6. パーキンソン病
[臨床試験数:2,123,薬物数:2,046(DrugBank:324),標的遺伝子数:183,標的パスウェイ数:198

Searched query = "Parkinson disease"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
1798 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
1NCT04468919
(ClinicalTrials.gov)
July 1, 20218/7/2020Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitOptimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitAmyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in SyndromeBehavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modelingOregon Health and Science UniversityNULLNot yet recruiting18 Years75 YearsAll60N/AUnited States
2NCT03309514
(ClinicalTrials.gov)
June 202110/10/2017Transplantation of Neural Stem Cell-Derived Neurons for Parkinson's DiseaseClinical Investigation of Transplantation of Neural Stem Cell-derived Neurons for the Treatment of Parkinson's DiseaseParkinson's DiseaseBiological: Intracerebral microinjectionsNeuroGenerationNULLNot yet recruiting35 Years85 YearsAll12Phase 1;Phase 2NULL
3NCT04287543
(ClinicalTrials.gov)
May 202121/2/2020Melatonin on Clock Genes in Parkinson's DiseaseEffect of Melatonin Administration on the PER1 and BMAL1 Clock Genes in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Melatonin;Drug: PlacebosInstituto Mexicano del Seguro SocialNULLWithdrawn20 YearsN/AAll0Phase 2;Phase 3Mexico
4NCT04322461
(ClinicalTrials.gov)
March 15, 202124/3/2020Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders PopulationEffect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKAParkinson Disease;Alzheimer DiseaseDietary Supplement: Betaquik MCT supplementUniversité de SherbrookeNestléNot yet recruiting60 YearsN/AAll20N/ANULL
5NCT04665869
(ClinicalTrials.gov)
March 15, 20217/12/2020Long-term Effects of Combined Balance and Brisk Walking in Parkinson's DiseaseLong-term Effects of Combined Balance and Brisk Walking on Alleviating Motor and Non-motor Symptoms in Parkinson's Disease: a Randomized Controlled TrialParkinson DiseaseBehavioral: Combined balance and brisk walking training;Behavioral: Flexibility and strengthening exerciseThe Hong Kong Polytechnic UniversityNULLNot yet recruiting30 Years80 YearsAll70N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
6NCT04373317
(ClinicalTrials.gov)
January 1, 202129/4/2020Pimavanserin vs. Quetiapine for the Treatment Parkinson's PsychosisCSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)Parkinson's Disease PsychosisDrug: Pimavanserin;Drug: QuetiapineVA Office of Research and DevelopmentNULLNot yet recruiting40 YearsN/AAll358Phase 4United States
7NCT04625361
(ClinicalTrials.gov)
January 1, 20219/11/2020Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of HEC122505MsOH Tablets in Healthy Adult SubjectsA Single Center, Randomized, Double-Blind, Placebo-Controlled Study of Single/Multiple Ascending Doses to Evaluate the Safety, Tolerability, Pharmacokinetics, and Single Center, Randomized, Double-Blind, Two Periods, Crossover, Food Effect Study of HEC122505MsOH Tablets in Healthy Chinese SubjectsParkinson DiseaseDrug: HEC122505MsOHSunshine Lake Pharma Co., Ltd.NULLNot yet recruiting18 Years45 YearsAll102Phase 1China
8NCT04643327
(ClinicalTrials.gov)
January 202118/11/2020Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's DiseaseDouble-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept StudyParkinson Disease;Mild Cognitive Impairment;Memory ImpairmentDrug: Levetiracetam;Drug: PlaceboThe University of QueenslandQueensland University of Technology;Johns Hopkins University;Cleveland Clinic Lou Ruvo Center for Brain Health;Royal Brisbane and Women's HospitalNot yet recruitingN/AN/AAll28Phase 2NULL
9NCT04590612
(ClinicalTrials.gov)
January 202117/9/2020Improving Quality of Life in Early Parkinson's DiseaseThe Effects of Mood Symptoms Treatment on Quality of Life and Motor Function in de Novo Parkinson's Disease PatientsParkinson Disease;DepressionDrug: Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet;Drug: CitalopramWestern University, CanadaNULLNot yet recruiting50 Years80 YearsAll30N/ANULL
10NCT04584346
(ClinicalTrials.gov)
December 17, 202010/10/2020Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)Acute Effects of Medium Chain Triglyceride (MCT) Nutritional Ketosis on Parkinson's Disease (PD) Symptoms and Biomarkers (MCT-PD)Parkinson's DiseaseDietary Supplement: Liquigen MCT oilNational Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting50 YearsN/AAll32Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
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size
PhaseCountries
11NCT04377945
(ClinicalTrials.gov)
December 1, 20204/5/2020Study in Parkinson's Disease Patients With Dyskinesia With Combinations of JM-010 and Its Individual ComponentsA Randomized, Double-Blind, Placebo-Controlled, Two-Part Study in Parkinson's Disease Patients With Dyskinesia to Assess the Efficacy and Safety/Tolerability of Fixed Dose Combinations of JM-010 and Its Individual ComponentsDyskinesia, Drug-InducedDrug: Part 1, JM-010 component Group A;Drug: Part 1, JM-010 component Group B;Drug: Part 1, JM-010 component Group C;Drug: Part 1, Placebo Group;Drug: Part 2, JM-010 combination Group A;Drug: Part 2, JM-010 combination Group B;Drug: Part 2, Placebo Group;Drug: Part 2, JM-010 component Group CBukwang PharmaceuticalNULLNot yet recruiting18 Years80 YearsAll188Phase 2United States
12NCT04346394
(ClinicalTrials.gov)
December 202010/3/2020The Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's DiseaseThe Role of the Noradrenergic System in the Nonmotor Symptoms of Parkinson's Disease: Orthostatic Hypotension and Other Nonmotor SymptomsParkinson DiseaseDrug: Yohimbine HClNathaniel M. RobbinsNULLNot yet recruitingN/AN/AAll22Early Phase 1NULL
13NCT04147949
(ClinicalTrials.gov)
December 202027/10/2019AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiaRandomized, Double-Blind, Placebo-Controlled, Crossover, Proof-of-Concept Phase 2 Study to Test Efficacy and Safety of AV-101 (L-4-chlorokynurenine) in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiaParkinson Disease;Dyskinesia, Medication-Induced;L-Dopa Causing Adverse Effects in Therapeutic UseDrug: AV-101;Drug: PlaceboVistaGen Therapeutics, Inc.NULLNot yet recruiting30 Years80 YearsAll20Phase 2NULL
14NCT04658186
(ClinicalTrials.gov)
December 20201/12/2020A 18-month Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Oral UCB0599 in Study Participants With Early-stage Parkinson's DiseaseA Double-Blind, Placebo-Controlled, Randomized, 18-Month Phase 2a Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Oral UCB0599 in Study Participants With Early Parkinson's DiseaseEarly-stage Parkinson's DiseaseDrug: UCB0599;Drug: PlaceboUCB Biopharma SRLNULLNot yet recruiting40 Years70 YearsAll300Phase 2NULL
15NCT04651153
(ClinicalTrials.gov)
December 202025/11/2020A Safety and Pharmacokinetics Study of UCB7853 in Healthy Study Participants and Study Participants With Parkinson's Disease (PD)A Multicenter, Participant-Blind, Investigator-Blind, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of UCB7853 in Healthy Male Study Participants and Multiple Ascending Doses in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: UCB7853;Other: PlaceboUCB Biopharma SRLNULLNot yet recruiting18 Years80 YearsAll64Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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Inclusion_
agemin
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PhaseCountries
16EUCTR2019-003315-60-NL
(EUCTR)
10/11/202008/10/2020A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go
Product Name: APO-go®
INN or Proposed INN: Apomorphine
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Product Name: APORON
INN or Proposed INN: APORON
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Criceto IKM B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2Netherlands
17EUCTR2019-004235-23-NL
(EUCTR)
09/11/202026/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;Italy;United Kingdom;Japan
18NCT04620382
(ClinicalTrials.gov)
November 9, 202027/10/2020Effect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsEffect of Midodrine vs Abdominal Compression on Cardiovascular Risk Markers in Autonomic Failure PatientsNeurogenic Orthostatic Hypotension;Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson DiseaseDrug: Midodrine;Drug: Placebo pill;Device: Abdominal compression;Device: sham compressionVanderbilt University Medical CenterNULLRecruiting40 Years80 YearsAll31Early Phase 1United States
19EUCTR2019-002952-17-CZ
(EUCTR)
04/11/202012/10/2020A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
20NCT04386317
(ClinicalTrials.gov)
November 1, 202024/4/2020Terazosin Effect on Cardiac Changes in Early Parkinson's DiseaseThe Effect of a1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's DiseaseREM Sleep Behavior Disorder;Pre-motor Parkinson's Disease;Symptomatic Parkinson DiseaseDrug: TerazosinCedars-Sinai Medical CenterNULLRecruiting25 Years85 YearsAll15Phase 2United States
No.TrialIDDate_
enrollment
Date_
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PhaseCountries
21NCT03903549
(ClinicalTrials.gov)
November 1, 20203/4/2019Initial Investigation of [18F]P17-059 in Parkinson's Disease Patients and Healthy VolunteersA Positron Emission Tomography (PET) Study to Investigate [18F]D6-FP-DTBZ ([18F]P17-059) for Potential Use as a Radioligand for Vesicular Monoamine Transporter (VMAT2)Parkinson DiseaseDrug: [18F]P17-059Five Eleven Pharma, Inc.NULLNot yet recruiting45 Years90 YearsAll26Phase 1United States
22ChiCTR2000038937
2020-11-012020-10-10Clinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imagingClinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imaging Parkinson's diseaseGold Standard:Clinical diagnosis by experienced movement disorder specialists after 2 years of follow-up.;Index test:Including traditional imaging feature algorithms (SUVR value, total cortical volume, bilateral cortical surface area, cortical thickness, etc.), high-dimensional imaging omics feature algorithms (energy entropy, gray-level co-occurrence matrix, and mutual information, etc.), and brain connection group Learning feature algorithm.;Huashan Hospital, Fudan UniversityNULLRecruiting4580BothTarget condition:105;Difficult condition:0China
23NCT04435431
(ClinicalTrials.gov)
October 29, 202015/6/2020A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced DyskinesiaA Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Mesdopetam;Drug: PlaceboIntegrative Research Laboratories ABNULLRecruiting30 Years79 YearsAll140Phase 2United States
24NCT04542499
(ClinicalTrials.gov)
October 27, 20202/9/2020Flexible-Dose, Adjunctive Therapy Trial in Adults With Parkinson's Disease With Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson's Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll368Phase 3United States;Australia;Czechia;Germany;Hungary;Poland
25EUCTR2020-003796-17-GB
(EUCTR)
22/10/202001/09/2020A study to look at the effect of CST-103 or CST-139 on blood flow in the brain and on memory.An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139 Patients with Mild Cognitive Impairment or Parkinson’s Disease
MedDRA version: 21.1;Level: LLT;Classification code 10009846;Term: Cognitive impairment;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Spiropent
Product Name: Clenbuterol HCl
Product Code: CST-103
INN or Proposed INN: CLENBUTEROL HYDROCHLORIDE
Trade Name: Berachin
Product Name: Tulobuterol
Product Code: CST-139
INN or Proposed INN: Tolubuterol Hydrochloride
Other descriptive name: TULOBUTEROL HYDROCHLORIDE
CuraSen Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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agemin
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PhaseCountries
26ChiCTR2000038852
2020-10-202020-10-07Study on the effect and mechanism of cognitive-cup-tapping-balance-training on fall prevention in community Parkinson's patients: a randomized controlled trialStudy on the effect and mechanism of cognitive-cup-tapping-balance-training on fall prevention in community Parkinson's patients: a randomized controlled trial Parkinson's diseasedual task training group :cognitive-cup-tapping balance training;single task training group:-cup-tapping balance training;control group:education;Shanghai University of SportNULLRecruiting4080Bothdual task training group :29;single task training group:29;control group:29;N/Achina
27NCT04380142
(ClinicalTrials.gov)
October 19, 20206/5/2020Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkinson's DiseaseA Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease PatientsParkinson's Disease (PD)Drug: ABBV-951;Drug: Placebo for Levodopa/Carbidopa (LD/CD);Drug: Levodopa/Carbidopa (LD/CD);Drug: Placebo for ABBV-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia
28NCT04502550
(ClinicalTrials.gov)
October 15, 202030/7/2020Brain Networks and ConsciousnessSubcortical-cortical Network Dynamics of Anesthesia and ConsciousnessLoss of Consciousness;Parkinson Disease;Essential Tremor;AnesthesiaDrug: PropofolUniversity of California, Los AngelesNULLRecruiting18 YearsN/AAll48United States
29ChiCTR2000037856
2020-10-012020-09-02Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA)Detection of A-synuclein Aggregate as Biomarker in Diagnosing Parkinson's Disease at Early Stage by Using Protein Misfolding Cyclic Amplification (PMCA) Parkinson's DiseaseGold Standard:DAT-PET and 18F-FDG PET ;Index test:a-synuclein protein misfolding cyclic amplification;Huashan Hospital Affiliated to Fudan UniversityNULLRecruiting5075BothTarget condition:150;Difficult condition:76China
30ChiCTR2000036006
2020-10-012020-08-21The applications of multi- MRI in early diagnosis of Parkinson's Disease based on deep learningThe applications of multi- MRI in early diagnosis of Parkinson's Disease based on deep learning Parkinson's diseaseGold Standard:MDS clinical diagnostic criteria for Parkinson’s disease;Index test:multimodal MRI features in locus coeruleus and substantia nigra;Zhongshan Hospital, Fudan UniversityNULLPending1885BothTarget condition:400;Difficult condition:0China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
Recruitment_
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Inclusion_
agemin
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PhaseCountries
31ChiCTR2000037239
2020-10-012020-08-27Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomicsConstruction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics Parkinson's diseaseGold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip;Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting5580BothTarget condition:500;Difficult condition:600China
32ChiCTR2000036137
2020-10-012020-08-21Clinical study of 18F-FDG combined with 18F-AV-133 PET/CT imaging in the diagnosis and differentiation of primary Parkinson's diseaseClinical study of 18F-FDG combined with 18F-AV-133 PET/CT imaging in the diagnosis and differentiation of primary Parkinson's disease Parkinson’s diseaseGold Standard:UK Parkinson's disease Society Brain Bank Clinical Diagnosis Criteria;Index test:18F-FDG combined with 18F-AV-133 PET/CT imaging;Renji Hospital (South Court), School of Medicine, Shanghai Jiao Tong UniversityNULLPendingBothTarget condition:50;Difficult condition:0China
33ChiCTR2000037624
2020-10-012020-08-29Clinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic studyClinical efficacy of dopamine agonist Pramipexol in the treatment of cognitive impairment in PATIENTS with PD-RBD and its population pharmacokinetic study Parkinson's diseaseexperimental group:Pramipexol + dopa hydrazine combination therapy;control group: dopa hydrazine;Shanghai General HospitalNULLRecruiting1885Bothexperimental group:50;control group:50;China
34NCT04593511
(ClinicalTrials.gov)
October 202021/9/2020to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy VolunteersAn Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular InjectionParkinson's DiseaseDrug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4Luye Pharma Group Ltd.NULLNot yet recruiting18 Years65 YearsAll40Phase 1NULL
35NCT04338997
(ClinicalTrials.gov)
October 20203/4/2020PK Study in Patients With Parkinson's Disease With IZD174An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: IZD174Inflazome UK LtdNULLWithdrawn45 Years75 YearsAll0Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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Recruitment_
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agemin
Inclusion_
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PhaseCountries
36NCT03665493
(ClinicalTrials.gov)
September 30, 20204/9/2018Dopamine Effect on Inhibitory ControlDopamine Effect on Inhibitory ControlIdiopathic Parkinson's DiseaseDrug: PD patients H&Y=1.5-2 Medications ON;Drug: PD patients H&Y=1.5-2 Medications OFF;Behavioral: Healthy age-matched controls;Drug: PD patients H&Y=3 Medications OFF;Drug: PD patients H&Y=3 Medications ONGiovanni MirabellaNULLRecruiting40 Years70 YearsAll102N/AItaly
37EUCTR2020-001175-32-GB
(EUCTR)
29/09/202007/08/2020Clinical study to evaluate the effect of opicapone 50 mg in the pain associated to Parkinson’s disease.Randomised, double-blind, placebo-controlled, clinical study to evaluate the effect of opicapone 50 mg on Parkinson’s disease patients with end-of-dose motor fluctuations and associated pain. - OpiCapone Effect on motor fluctuations and pAiN (OCEAN) Parkinson's disease patients with wearing-off motor fluctuations andassociated pain.
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ongentys
Product Name: Ongentys
INN or Proposed INN: Opicapone
Bial - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
176Phase 4Portugal;Spain;Germany;Italy;United Kingdom
38NCT04591535
(ClinicalTrials.gov)
September 28, 202011/9/2020PK Study of WD-1603 in Healthy SubjectsAn Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed ConditionsParkinson DiseaseDrug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
39NCT04553978
(ClinicalTrials.gov)
September 18, 202013/9/2020A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting ConditionsAn Open Label, Balanced, Randomised, 2-treatment, 2-period, 2-sequence, Single Oral Dose, Corssover Comparative PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fasting ConditionsParkinson DiseaseDrug: WD-1603Hong Kong WD Pharmaceutical Co., LimitedNULLNot yet recruiting18 Years45 YearsAll8Phase 1NULL
40EUCTR2019-004235-23-GB
(EUCTR)
15/09/202028/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Japan;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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Inclusion_
agemin
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size
PhaseCountries
41NCT04476017
(ClinicalTrials.gov)
September 11, 202015/7/2020A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive ImpairmentParkinson Disease;Cognitive DysfunctionDrug: SAGE-718Sage TherapeuticsNULLRecruiting50 Years75 YearsAll22Phase 2United States
42EUCTR2019-002949-38-DE
(EUCTR)
07/09/202021/01/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
552Phase 3United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
43ChiCTR2000037828
2020-09-012020-09-02Clinical study of Wuqinxi combined with selegilan in improving frozen gait of Parkinson's diseaseClinical study of Wuqinxi combined with selegilan in improving frozen gait of Parkinson's disease Parkinson's diseaseGroup 1:Routine anti PD treatment + stretching training;Group 2:Routine anti PD treatment + stretching training + selegiline;Group 3:Routine anti PD treatment + Wuqinxi training;Group 4:Routine anti PD treatment + Wuqinxi training + selegiline;Union Medical College Affiliated Hospital of Tongji Medical College, Huazhong University of science and technologyNULLRecruiting4080MaleGroup 1:30;Group 2:30;Group 3:30;Group 4:30;China
44ChiCTR2000035872
2020-09-012020-08-19Effect of repetitive transcranial magnetic stimulation on gait and balance function in patients with Parkinson's disease and Parkinson's syndromeEffect of repetitive transcranial magnetic stimulation on gait and balance function in patients with Parkinson's disease and Parkinson's syndrome Parkinson's disease and Parkinson's syndromeParkinson's disease observation group:Repetitive transcranial magnetic stimulation+Visual feedback balance training system+Digital treadmill ;Parkinson's disease control group:Visual feedback balance training system+Digital treadmill;Parkinson's syndrome observation group:Repetitive transcranial magnetic stimulation+Visual feedback balance training system+Digital treadmill;Parkinson's syndrome control group:Visual feedback balance training system+Digital treadmill ;Gansu Provincial HospitalNULLPending5085BothParkinson's disease observation group:28;Parkinson's disease control group:28;Parkinson's syndrome observation group:28;Parkinson's syndrome control group:28;China
45NCT04332276
(ClinicalTrials.gov)
September 202025/3/2020Dopaminergic restauratIon by intraVEntriculaire AdministrationA New Concept of Continuous Dopaminergic Stimulation by Cerebroventricular Administration of A-dopamine (Dopamine Stored in Anaerobia) for Severe Motor Fluctuations in Parkinson's Disease?Parkinson DiseaseDrug: A-dopamineUniversity Hospital, LilleInBrain PharmaNot yet recruiting45 Years75 YearsAll20Phase 1;Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2019-004235-23-IT
(EUCTR)
26/08/202022/10/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. - na Parkinson's Disease
MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: [ABBV-951]
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;United Kingdom;Japan;Italy
47ChiCTR2000035564
2020-08-172020-08-13Pharmacokinetics and Bioequivalence study of Pramipexole Extended-Release Tablets in Healthy Chinese VolunteersPharmacokinetics and Bioequivalence study of Pramipexole Extended-Release Tablets in Healthy Chinese Volunteers Parkinson’s diseasefasting administration group-TR:phase I: Pramipexole Extended-Release Tablets; phase II: Reference preparation;fasting administration group-RT:phase I: Reference preparation: pahse II: Test preparation;high-fat postprandial administration group-TR:phase I: Pramipexole Extended-Release Tablets; phase II: Reference preparation;high-fat postprandial administration group-RT:phase I: Pramipexole Extended-Release Tablets; phase II: Reference preparation;West China Hospital of Sichuan UniversityNULLRecruiting1865Bothfasting administration group-TR:28;fasting administration group-RT:28;high-fat postprandial administration group-TR:28;high-fat postprandial administration group-RT:28;Phase 1China
48NCT04513340
(ClinicalTrials.gov)
August 13, 202012/8/2020WD-1603 PK Study Under Fasting and Fed Conditions in Healthy SubjectsAN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONSParkinson DiseaseDrug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
49NCT04449484
(ClinicalTrials.gov)
August 4, 202023/4/2019Multiple Ascending Dose Study of MEDI1341 in Patients With Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of MEDI1341 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: MEDI1341;Other: PlaceboAstraZenecaNULLRecruiting40 Years85 YearsAll36Phase 1United States
50ChiCTR2000034323
2020-08-012020-07-02The effect and correlation of rehabilitation training mode combined with visual feedback balance system and digital treadmill on three-dimensional Gait kinematics and diffusion tensor imaging in patients with early and mid period Parkinson's diseaseThe effect of rehabilitation training mode combined with visual feedback balance system and digital treadmill on Gait kinematics and diffusion tensor imaging in patients with early and mid period Parkinson's disease Parkinson's diseaseexperimental group:Combined Rehabilitation Training of visual feedback balance system and digital treadmill;control group:Traditional Gait Balance Rehabilitation Training;Xianhui FengNULLPendingBothexperimental group:30;control group:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04483479
(ClinicalTrials.gov)
July 30, 202020/7/2020Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week PeriodParkinson Disease;ConstipationDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLRecruiting30 Years90 YearsAll50Phase 2United States
52EUCTR2019-002951-40-DE
(EUCTR)
29/07/202012/02/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
53NCT04630860
(ClinicalTrials.gov)
July 7, 20205/11/2020A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PDA Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLRecruiting18 Years80 YearsAll30Phase 1China
54EUCTR2019-002951-40-HU
(EUCTR)
02/07/202029/04/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden
55JPRN-UMIN000040889
2020/06/2424/06/2020Comparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's diseaseComparison of gastrointestinal function before and after levodopa-carbidopa continuous infusion gel (LCIG) therapy for patients with Parkinson's disease - Comparison of gastrointestinal function before and after LCIG therapy for Parkinson's disease Parkinson's diseaseLevodopa-carbidopa continuous infusion gel (LCIG) therapyFujita Health University School of MedicineDepartment of GastroenterologyNULLRecruiting20years-oldNot applicableMale and Female200Phase 4Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-004156-37-PT
(EUCTR)
16/06/202009/12/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD/CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;France;Italy;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
57EUCTR2018-004156-37-NL
(EUCTR)
14/06/202013/01/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3Portugal;Serbia;United States;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Netherlands;Sweden;Korea, Republic of
58EUCTR2019-002951-40-CZ
(EUCTR)
03/06/202025/02/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
59NCT04384666
(ClinicalTrials.gov)
June 2, 20208/5/2020A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersA Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersParkinson DiseaseDrug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal PatchLuye Pharma Group Ltd.NULLCompleted18 Years45 YearsAll56Phase 1United States
60NCT04414813
(ClinicalTrials.gov)
June 202021/5/2019Stereotactic Transplantation of hAESCs for Parkinson's DiseaseClinical Study of Stereotactic Transplantation of Human Amniotic Epithelial Stem Cells (hAESCs) in the Treatment of Parkinson's Disease (PD)Parkinson's DiseaseBiological: Human Amniotic Epithelial Stem CellsShanghai East HospitalShanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaNot yet recruiting30 Years70 YearsAll3Early Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61ChiCTR2000032616
2020-05-302020-05-04Assistant diagnosis machinery system development based on speech and movement sensitive device for Parkinson's diseaseParkinson's disease, Assistant diagnosis machinery system, speech, movement sensitive device Parkinson's diseaseGold Standard:clinical outcome meet 2015 MDS-probable PD criteria;Index test:Acoustic receptive and analysis device,Wearable movement sensor;Shanghai Jiao Tong University School of Medicine affiliated Shanghai General HospitalNULLPendingBothTarget condition:20;Difficult condition:80China
62NCT04379050
(ClinicalTrials.gov)
May 19, 20201/5/2020Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's DiseaseAn Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLEnrolling by invitation30 YearsN/AAll121Phase 3United States;Australia;Belgium;Canada;Denmark;Italy;Japan;Netherlands;Spain;United Kingdom
63EUCTR2018-004156-37-SE
(EUCTR)
18/05/202010/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
64NCT03568968
(ClinicalTrials.gov)
May 15, 202014/6/2018A Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's DiseaseA Randomized Controlled Trial of Nicotinamide Supplementation in Early Parkinson's Disease: the NOPARK StudyParkinson DiseaseDietary Supplement: Nicotinamide Riboside;Drug: PlaceboHaukeland University HospitalNULLRecruiting18 YearsN/AAll400N/ANorway
65EUCTR2019-002949-38-PL
(EUCTR)
13/05/202020/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2018-002144-85-DE
(EUCTR)
07/05/202006/06/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan
67EUCTR2019-002950-22-HU
(EUCTR)
06/05/202012/03/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's DiseaseA Phase 3, Double-Blind, Randomized, Placebo Controlled, Parallel Group, Flexible-Dose, 27 Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson’s Disease (TEMPO 2 Trial) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
296Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany
68NCT04265209
(ClinicalTrials.gov)
May 20206/2/2020[18F] LBT-999 PET Compared to [123I]-FP/CIT SPECT to Distinguish Between Parkinson's Diseases and Essential TremorNon-inferiority Study of the Molecular Imaging of Dopamine Transporters Using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to Distinguish Between Parkinson's Disease and Essential Tremor.Parkinson Disease;Essential TremorDrug: SPECT;Drug: PETZionexaNULLNot yet recruiting35 Years80 YearsAll112Phase 3NULL
69NCT04459052
(ClinicalTrials.gov)
April 30, 202026/6/2020FDOPA PET and Nutritional Support in Parkinson's DiseasePhase II: Physiological Effects of Nutritional Support in Patients With Parkinson's DiseaseParkinson Disease;Idiopathic Parkinson DiseaseDietary Supplement: N acetyl cysteine;Drug: [F-18] Fluorodopa Positron Emission TomographyThomas Jefferson UniversityNULLActive, not recruiting30 YearsN/AAll50Phase 2United States
70EUCTR2018-004156-37-SK
(EUCTR)
30/04/202013/02/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Levodopa/Carbidopa Solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Serbia;Portugal;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2018-004156-37-BE
(EUCTR)
27/04/202003/03/2020A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
72EUCTR2018-002233-37-PL
(EUCTR)
23/04/202024/01/2020Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy
73EUCTR2019-002951-40-ES
(EUCTR)
14/04/202006/03/2020A clinical trial which runs in multiple countries and aims to analyse how efficient, safe and tolerable the investigational product (TAVAPADON) is compared with placebo treatment when given in multiple doses for patients diagnosed with Parkinson's Disease with Motor FluctuationsA Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon as Adjunctive Therapy for Parkinson’s Disease in Levodopa-Treated Adults With Motor Fluctuations (TEMPO-3 Trial) - TEMPO-3 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease with Motor Fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
368Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
74EUCTR2019-002949-38-ES
(EUCTR)
07/04/202028/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
75ChiCTR2000029465
2020-04-062020-02-02Comparison of effects of sitagliptin and metformin on motor function and cognitive function in patients with Parkinson's disease complicated with type 2 diabetesComparison of effects of sitagliptin and metformin on motor function and cognitive function in patients with Parkinson's disease complicated with type 2 diabetes Type 2 DiabetesSitagliptin group:Sitagliptin 100mg/d for 52 weeks;metformin group:metformin 1000-1500mg/d for 52 weeks;Peking Union Medical College HospitalNULLPending1875BothSitagliptin group:20;metformin group:20;Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT04167540
(ClinicalTrials.gov)
April 1, 20207/11/2019GDNF Gene Therapy for Parkinson's DiseaseOpen-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's DiseaseParkinson's DiseaseBiological: AAV2-GDNFBrain Neurotherapy Bio, Inc.NULLRecruiting35 Years75 YearsAll12Phase 1United States
77NCT02967250
(ClinicalTrials.gov)
April 1, 202013/9/2016Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA Treatment7T Magnetic Resonance Spectroscopy Monitoring Brain Bioenergetics in Parkinson's Disease and Response to Repeated Oral UDCA TreatmentParkinson DiseaseDrug: ursodeoxycholic acidUniversity of MinnesotaNULLNot yet recruiting18 YearsN/AAll20Phase 1United States
78NCT04182399
(ClinicalTrials.gov)
April 1, 202024/11/2019Role of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot StudyRole of Zonisamide in Advanced Parkinson's Disease (PD) in Egyptian Population: Pilot StudyParkinson DiseaseDrug: Zonisamide CapsulesAin Shams UniversityNULLRecruiting18 YearsN/AAll90N/AEgypt
79NCT04342273
(ClinicalTrials.gov)
March 31, 20208/4/2020A Through QT/QTc Study of KW-6356A Through QT/QTc Study of KW-6356 in Japanese Healthy AdultsParkinson's DiseaseDrug: KW-6356;Drug: Placebo;Drug: MoxifloxacinKyowa Kirin Co., Ltd.NULLCompleted20 Years54 YearsAll128Phase 1Japan
80EUCTR2020-000686-16-NL
(EUCTR)
26/03/202009/03/2020Validation of finger tapping in PD patientsRandomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson’s Disease patients. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 125
Product Name: SINEMET
Product Code: RVG 08740
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopamonohydraat
Other descriptive name: CARBIDOPA MONOHYDRATE
Centre for Human Drug ResearchNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 2Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2019-003962-41-GB
(EUCTR)
23/03/202006/02/2020Trial of Ondansetron as a Parkinson's HAllucinations Treatment: TOP HATTrial of Ondansetron as a Parkinson’s HAllucinations Treatment - TOP HAT Adults aged over 18 years with Parkinson's disease and visual hallucinations
MedDRA version: 21.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations;System Organ Class: 100000004873;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
Trade Name: Ondansetron 8 mg film-coated tablets
Product Name: Ondansetron 8 mg film-coated tablets
INN or Proposed INN: Ondansetron hydrochloride dihydrate
University College LondonNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
216Phase 2United Kingdom
82NCT04269642
(ClinicalTrials.gov)
March 19, 202013/1/2020SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's DiseasePhase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's DiseaseEarly Parkinson's DiseaseDrug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mgPeptron, Inc.NULLRecruiting40 Years75 YearsAll99Phase 2Korea, Republic of
83EUCTR2018-003941-41-AT
(EUCTR)
05/03/202019/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
84EUCTR2019-002949-38-CZ
(EUCTR)
04/03/202019/12/2019A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
85NCT04127695
(ClinicalTrials.gov)
March 3, 20209/10/2019A Study to Evaluate the Safety and Tolerability of ABBV-0805 in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Placebo Controlled Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of ABBV-0805 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ABBV-0805;Drug: Placebo ABBV-0805AbbVieNULLWithdrawnN/A85 YearsAll0Phase 1United States;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2018-004156-37-AT
(EUCTR)
02/03/202005/11/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Portugal;Serbia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
87NCT04260581
(ClinicalTrials.gov)
March 1, 20205/2/2020Is Long-term Use of Amantadine Effective in PD?Is Long-term Use of Amantadine Effective in Parkinson Disease?Parkinson DiseaseDrug: Determination of drug effects through amantadine cessationSeoul National University HospitalNULLNot yet recruiting40 YearsN/AAll32N/AKorea, Republic of
88NCT04154072
(ClinicalTrials.gov)
February 27, 20204/11/2019A Clinical Study of NLY01 in Patient's With Early Parkinson's DiseaseMulticenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of 36 Weeks of Treatment With NLY01 in Early-stage Parkinson's DiseaseParkinson DiseaseDrug: NLY01;Drug: VehicleNeuraly, Inc.NULLRecruiting30 Years80 YearsAll240Phase 2United States;Canada
89NCT04291859
(ClinicalTrials.gov)
February 26, 202028/2/2020Lu AF28996 in Patients With Parkinson's Disease (PD)Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Lu AF28996H. Lundbeck A/SNULLRecruiting45 Years75 YearsAll10Phase 1Netherlands
90EUCTR2018-004156-37-ES
(EUCTR)
11/02/202006/11/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT04292223
(ClinicalTrials.gov)
February 10, 202028/2/2020Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisA 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: PimavanserinACADIA Pharmaceuticals Inc.NULLRecruiting40 YearsN/AAll53Phase 4United States
92EUCTR2019-002949-38-HU
(EUCTR)
06/02/202017/12/2019A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (18 to 60 years age) who have diagnosis of Parkinson's DiseaseProduct Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Hungary;Czech Republic;Canada;Poland;Australia;Bulgaria;Germany;Sweden
93EUCTR2018-002234-21-GB
(EUCTR)
05/02/202004/07/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom
94NCT04251585
(ClinicalTrials.gov)
February 4, 202028/1/2020Intranasal Insulin in Parkinson's DiseaseSingle Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's DiseaseParkinson DiseaseDrug: Regular Novolin R;Drug: PlaceboHealthPartners InstituteNULLRecruiting41 Years89 YearsAll30Phase 2United States
95NCT04246437
(ClinicalTrials.gov)
February 4, 202025/1/2020[18F]F-DOPA Imaging in Patients With Autonomic Failure[18F]F-DOPA Imaging in Patients With Autonomic FailureAutonomic Failure;Pure Autonomic Failure;Parkinson Disease;Multiple System Atrophy;Dementia With Lewy BodiesDrug: [18F]FDOPA;Drug: Carbidopa 200mg oral dose;Drug: Entacapone 400mg oral doseDaniel ClaassenNULLRecruiting18 YearsN/AAll40Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2018-003941-41-PT
(EUCTR)
03/02/202021/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
97NCT04428983
(ClinicalTrials.gov)
February 3, 202020/11/2019The Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's DiseaseThe Effect of Hericium Erinaceus Mycelium in Non-motor Symptoms of Parkinson's DiseaseParkinson DiseaseDietary Supplement: Hericium erinaceus myceliumNational Cheng-Kung University HospitalNULLRecruiting50 Years79 YearsAll80N/ATaiwan
98EUCTR2018-003289-15-DE
(EUCTR)
28/01/202008/02/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Denmark;Bulgaria;Germany
99NCT04322227
(ClinicalTrials.gov)
January 23, 202029/1/2020Study Investigating Effects of Foliglurax in Patients With Parkinson's Disease (PD) and Healthy SubjectsInterventional, Randomized, Double-blind, Placebo-controlled Three-way Crossover Study Investigating the Pharmacodynamic Effects of Two Doses of Foliglurax Using Electroencephalography in Patients With Parkinson's Disease and in Healthy SubjectsParkinson Disease;HealthyDrug: Foliglurax 10 mg (treatment A);Drug: Foliglurax 30 mg (treatment B);Drug: Placebo (treatment C)H. Lundbeck A/SNULLTerminated50 Years70 YearsAll6Phase 1France
100NCT04220762
(ClinicalTrials.gov)
January 21, 202017/12/2019A Study to Determine the Dose of WIN-1001X by Evaluating Efficacy and Safety in Early Parkinson's Disease PatientsA Clinical Study to Determine the Optimal Dose of WIN-1001X by Evaluating Its Efficacy and Safety in Patients With Early Parkinson's Disease: Double-blind, Randomized, Placebo-controlled, Multicenter, Phase II StudyParkinson DiseaseDrug: WIN-1001X;Drug: PlaceboMedi Help LineNULLRecruiting30 YearsN/AAll188Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT04232969
(ClinicalTrials.gov)
January 20, 202010/1/2020Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's DiseaseA Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's DiseaseParkinson's DiseaseDrug: Exenatide extended release 2mg (Bydureon)University College, LondonNULLRecruiting25 Years80 YearsAll200Phase 3United Kingdom
102NCT04369430
(ClinicalTrials.gov)
January 16, 202013/4/2020Study Assessing Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic TreatmentA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects With Parkinson's Disease on Stable Dopaminergic TreatmentParkinson DiseaseDrug: AKST4290;Drug: PlaceboAlkahest, Inc.NULLRecruiting50 Years80 YearsAll120Phase 2United States;Estonia;Germany;Poland;Slovakia;Hungary
103EUCTR2019-001657-42-SK
(EUCTR)
14/01/202001/10/2019A study to learn how well the drug AKST4290 works and how safeAKST4290 is in people who have Parkinson's disease that are takingdopamine based medication.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate theEfficacy and Safety of AKST4290 in Subjects with Parkinson's Disease onStable Dopaminergic Treatment. - N/A Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Hungary;Estonia;Slovakia;Poland;Germany
104EUCTR2018-004156-37-GB
(EUCTR)
14/01/202013/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
105EUCTR2018-003289-15-PT
(EUCTR)
13/01/202021/08/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT04295642
(ClinicalTrials.gov)
January 8, 202024/1/2020A 2-Part Trial of CVL-751 in Subjects With Parkinson's DiseaseA 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: CVL-751Cerevel Therapeutics, LLCNULLRecruiting45 Years75 YearsAll33Phase 1United States
107NCT04223193
(ClinicalTrials.gov)
January 6, 20207/1/2020Flexible-Dose Trial in Early Parkinson's Disease (PD)A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Flexible-Dose, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Tavapadon in Early Parkinson's Disease (TEMPO-2 Trial)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll296Phase 3United States
108NCT04127578
(ClinicalTrials.gov)
January 3, 202014/10/2019Phase 1/2a Clinical Trial of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 MutationParkinson DiseaseBiological: PR001A;Drug: Methylprednisolone;Drug: Sirolimus;Drug: PrednisonePrevail TherapeuticsNULLRecruiting35 Years80 YearsAll12Phase 1;Phase 2United States
109NCT04152655
(ClinicalTrials.gov)
January 1, 20207/10/2019A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson DiseaseA Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)REM Sleep Behavior Disorder;Parkinson DiseaseDrug: Idebenone;Drug: Placebo oral tabletSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting18 YearsN/AAll180Phase 2;Phase 3China
110NCT04301492
(ClinicalTrials.gov)
January 1, 202017/2/2020Tolerability, Safety and Efficacy of VortioxetineTolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label StudyDepressionDrug: VortioxetineIRCCS San RaffaeleNULLRecruiting30 Years80 YearsAll20Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03808961
(ClinicalTrials.gov)
January 1, 202016/1/2019Niacin for Parkinsons DiseaseNAPS: Niacin for Parkinsons DiseaseParkinson's DiseaseDietary Supplement: Niacin;Dietary Supplement: Niacinamide;Other: PlaceboVA Office of Research and DevelopmentNULLRecruiting35 YearsN/AAll100N/AUnited States
112NCT04218968
(ClinicalTrials.gov)
December 30, 201926/12/2019Cardiac Changes in Early Parkinson's Disease: A Follow up StudyThe Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up StudyREM Sleep Behavior Disorder;Pre-motor Parkinson Disease;Symptomatic Parkinson DiseaseDrug: CarvedilolCedars-Sinai Medical CenterNULLEnrolling by invitation18 Years85 YearsAll15Phase 2United States
113EUCTR2018-004156-37-HU
(EUCTR)
19/12/201918/10/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
350Phase 3Serbia;Portugal;United States;Slovakia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Netherlands;Korea, Republic of;Sweden
114NCT04164121
(ClinicalTrials.gov)
December 17, 201912/11/2019A Clinical Study Trial of Phenlarmide in ChinaA Randomized, Double-blind, Placebo-controlled, Single-dose, Multiple-dose, Incremental Tolerance and Pharmacokinetics Study of Phenlarmide Tablets in Chinese Healthy Adult VolunteersParkinson DiseaseDrug: Phenlarmide Tablets;Drug: PlacebosYiling Pharmaceutical Inc.NULLRecruiting18 Years65 YearsAll36Phase 1China
115NCT04097080
(ClinicalTrials.gov)
December 15, 201918/9/2019Comparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's DiseaseComparative Controlled Study of Analgesic, Antiasthenic and Anti-Anxiety Effects of Xenon in Patients With Parkinson's DiseaseParkinson DiseaseDrug: NBTX-001;Drug: Standard of CareNobilis Therapeutics Inc.NULLRecruiting18 YearsN/AAll60Phase 1Russian Federation
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT04201093
(ClinicalTrials.gov)
December 13, 201913/12/2019Fixed-Dose Trial in Early Parkinson's Disease (PD)A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, 27-Week Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses of Tavapadon in Early Parkinson's Disease (TEMPO-1 TRIAL)Parkinson DiseaseDrug: Tavapadon;Drug: PlaceboCerevel Therapeutics, LLCNULLRecruiting40 Years80 YearsAll522Phase 3United States;Australia
117NCT04183634
(ClinicalTrials.gov)
December 3, 201928/11/2019An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.Parkinson DiseaseDrug: Rotigotine TTS (Test);Drug: Neupro (Reference)SandozNULLTerminated18 Years80 YearsAll31Phase 1Germany
118EUCTR2018-003089-14-GB
(EUCTR)
03/12/201907/10/2019Can suppressing the immune system with azathioprine slow down the progression of Parkinson's disease?Azathioprine Immunosuppression and Disease Modification in Parkinson’s Disease (AZA-PD): a randomised double-blind placebo-controlled phase II trial - AZA-PD Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Azathioprine
INN or Proposed INN: Azathioprine
Cambridge University Hospitals NHS Foundation Trust and University of CambridgeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2United Kingdom
119NCT04191577
(ClinicalTrials.gov)
December 2, 201930/10/2019Study of CVN424 in Parkinson's Disease Patients With Motor FluctuationsA Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of CVN424 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: CVN424 Low Dose;Drug: CVN424 High Dose;Drug: PlaceboCerevance Beta, Inc.NULLRecruiting30 Years80 YearsAll66Phase 2United States
120NCT03436953
(ClinicalTrials.gov)
December 20197/2/2018A Phase 2 Study of CX-8998 in Adults With Tremor Associated With Parkinson's DiseaseA Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of CX-8998 for Tremor Associated With Parkinson's DiseaseParkinson's Disease;TremorDrug: CX-8998;Drug: PlaceboJazz PharmaceuticalsNULLNot yet recruiting40 Years80 YearsAll60Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-004156-37-CZ
(EUCTR)
26/11/201926/09/2019A clinical study to investigate the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral treatment in subjects with Parkinson’s disease (BouNDless)A multicenter, randomized, active-controlled, double-blind, double-dummy, parallel group clinical trial, investigating the efficacy, safety, and tolerability of continuous subcutaneous ND0612 infusion in comparison to oral IR-LD/CD in subjects with Parkinson’s disease experiencing motor fluctuations (BouNDless) - BouNDless Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: IR LD / CD
Product Name: Carbidopa and Levodopa tablets, USP
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
482Phase 3United States;Serbia;Portugal;Czechia;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Netherlands;Sweden;Korea, Republic of
122ChiCTR1900027306
2019-11-152019-11-08Application of optical coherence tomography and detection of a-synuclein in tears in the diagnosis of Parkinson's diseaseMorphological changes of retina in patients with Parkinson's disease and the role of a-synuclein in retinal damage Parkinson's diseaseGold Standard:British brain bank Parkinson's disease diagnostic criteria;Index test:Application of optical coherence tomography to observe the retinal structure of the macular area, optic disc area and the expression level of a-synuclein in tears in the diagnosis of Parkinson's disease.;The First Affiliated Hospital of Chengdu Medical CollegeNULLRecruitingBothTarget condition:85;Difficult condition:85China
123NCT04175132
(ClinicalTrials.gov)
November 12, 201912/11/2019Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's DiseaseHealthy;Parkinson DiseaseDrug: foligluraxH. Lundbeck A/SNULLTerminated50 Years70 YearsAll6Phase 1Sweden
124NCT03652870
(ClinicalTrials.gov)
November 1, 20198/8/2018Antidepressants Trial in Parkinson's DiseaseA Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's DiseaseDepression;Parkinson DiseaseDrug: Nortriptyline;Drug: Escitalopram;Drug: PlaceboUniversity College, LondonLondon North West Healthcare NHS Trust;King's College London;University Hospital Plymouth NHS Trust;NHS LothianNot yet recruiting18 Years85 YearsAll408Phase 3NULL
125ChiCTR1900027210
2019-11-012019-11-05Effects of different anesthesia methods on postoperative delirium in patients with Parkinson's disease and biological markers of postoperative delirium in patients with Parkinson's diseaseEffects of different anesthesia methods on postoperative delirium in patients with Parkinson's disease and biological markers of postoperative delirium in patients with Parkinson's disease Delirium1:Total Intravenous Anesthesia;2:Balance Anesthesia;Tsinghua University Yuquan HospitalNULLRecruitingFemale1:60;2:60;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2018-002942-35-GB
(EUCTR)
31/10/201905/09/2019A Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo, and standard psychological care, for depression in Parkinson’s diseaseA Randomised Controlled Trial of Escitalopram and Nortriptyline compared with placebo and standard psychological care for depression in Parkinson’s Disease - Antidepressants Trial in Parkinson's Disease (ADepT-PD) Depression in Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10012378;Term: Depression;System Organ Class: 10037175 - Psychiatric disorders
MedDRA version: 20.0;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Escitalopram
INN or Proposed INN: Escitalopram oxalate
Trade Name: Nortriptyline
Product Name: Nortriptyline
INN or Proposed INN: Nortriptyline hydrochloride
University College London Comprehensive Clinical Trials UnitNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
408Phase 3United Kingdom
127EUCTR2018-003941-41-DK
(EUCTR)
29/10/201924/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Denmark;Australia;Bulgaria;Germany;New Zealand
128EUCTR2019-000732-26-SE
(EUCTR)
23/10/201907/05/2019Exenatide Treatment in Parkinson's DiseaseEffect of Exenatide on disease progression in early Parkinson's disease. Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Bydureon 2 mg powder and solvent for prolonged-release suspension
Product Name: BYDUREON
INN or Proposed INN: EXENATIDE
Stockholm Health Care ServicesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Sweden
129NCT04164758
(ClinicalTrials.gov)
October 23, 201913/11/2019Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineA Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose QuetiapineParkinson's DiseaseDrug: Pimavanserin;Other: Placebo;Drug: QuetiapineACADIA Pharmaceuticals Inc.NULLTerminated50 Years85 YearsAll11Phase 2United States
130EUCTR2019-001657-42-DE
(EUCTR)
22/10/201911/06/2019A study to learn how well the drug AKST4290 works and how safe AKST4290 is in people who have Parkinson's disease that are taking dopamine based medication.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AKST4290 in Subjects with Parkinson's Disease on Stable Dopaminergic Treatment - N/A Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AKST4290
Product Code: AKST4290
INN or Proposed INN: AKST4290
Other descriptive name: 2-[[[(2R)-1-[1-[(4-CHLORO-3-METHYLPHENYL)METHYL]-4- PIPERIDINYL]-5-OXO-2-PYRROLIDINYL]CARBONYL]AMINO]- N,N,6-TRIMETHYL-4-PYRIDINECARBOXAMIDE,DIHYDROCHLORIDE
Alkahest, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Estonia;Hungary;Slovakia;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131ChiCTR1900026956
2019-10-212019-10-27Minimum alveolar concentration-awake of sevoflurane in patients with Parkinson's diseaseMinimum alveolar concentration-awake of sevoflurane in patients with Parkinson's disease Parkinson’s diseaseParkinson’s disease group:Sevoflurane induction;Non-Parkinson’s disease group:Sevoflurane induction;The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of ChinaNULLPending4064BothParkinson’s disease group:30;Non-Parkinson’s disease group:30;N/AChina
132EUCTR2018-003337-15-ES
(EUCTR)
17/10/201930/04/2019A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease Early Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sun Pharma Advanced Research Company (SPARC) LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
504Phase 2United States;Hungary;Czech Republic;Slovakia;Poland;Spain;India
133NCT04273932
(ClinicalTrials.gov)
October 17, 201931/10/2019Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.Effects of Lithium Therapy on Blood-based Therapeutic Targets in Parkinson's Disease.Parkinson DiseaseDrug: LithiumUniversity at BuffaloNULLRecruiting45 Years80 YearsAll20Phase 1United States
134NCT04157933
(ClinicalTrials.gov)
October 16, 20191/11/2019Staccato Apomorphine Multi-dose PK and PD in Patients With Parkinson's DiseaseA Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamic Profile of AZ-009 in Subjects With Established Parkinson's DiseaseParkinson's DiseaseDrug: 009-A1;Drug: 009-A2;Drug: 009-A3;Drug: 009-A0;Drug: 009-B1 (active --> placebo) crossover;Drug: 009-B2 (placebo --> active) crossoverAlexza Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll35Phase 1Netherlands
135NCT04165837
(ClinicalTrials.gov)
October 14, 201913/11/2019Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy SubjectsA Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral FB-101 in Healthy SubjectsParkinson's DiseaseDrug: FB-101;Drug: Placebo1ST Biotherapeutics, Inc.NULLRecruiting19 Years55 YearsAll48Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136JPRN-jRCTs031190115
11/10/201911/10/2019PK & PD of coadministration of XOR inhibitor and inosinePharmacokinetics and pharmacodynamics study of coadministration of either allopurinol or febuxostat and inosine Parkinson's disease
neurodegenerative disease
Coadministration of allopurinol and inosine, or coadministration of febuxostat and inosineKamatani NaoyukiNULLRecruiting>= 20age old<= 40age oldMale28Phase 1Japan
137EUCTR2018-002233-37-GB
(EUCTR)
11/10/201914/02/2019Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
138EUCTR2018-003941-41-BG
(EUCTR)
10/10/201926/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
139EUCTR2018-003289-15-BG
(EUCTR)
10/10/201924/07/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
140NCT03987750
(ClinicalTrials.gov)
October 201912/6/2019Safinamide for Levodopa-induced Dyskinesia (PD-LID)A Phase 3, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of 2 Doses of Safinamide Compared to Placebo in the Treatment of LID in PD Patients With Motor FluctuationsDyskinesia, Drug-Induced;Parkinson DiseaseDrug: Safinamide Methanesulfonate 150mg;Drug: Safinamide Methanesulfonate 100mg;Drug: Safinamide Methanesulfonate matching placeboZambon SpANULLWithdrawn30 YearsN/AAll0Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2018-002234-21-DE
(EUCTR)
23/09/201916/05/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
142ChiCTR1900025894
2019-09-112019-09-12Parallel randomized controlled trial for Shengyang Yiwei Granule in the treatment of early Parkinson's diseaseParallel randomized controlled trial for Shengyang Yiwei Granule in the treatment of early Parkinson's disease parkinson diseaseexperimental group:Parkinson's disease routine medication, plus Shengyang Yiwei granules, water blunt, one dose, morning and evening;control group:Parkinson's disease routine medication, add Buzhong Yiqi granules, water blunt, one dose, morning and evening;Kaida WangNULLRecruitingBothexperimental group:45;control group:23;China
143EUCTR2018-002144-85-NL
(EUCTR)
11/09/201927/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
144NCT04477161
(ClinicalTrials.gov)
September 5, 201922/6/2020Effect of Ketone Esters in Parkinson's DiseaseEffect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.Parkinson Disease;KetosisDietary Supplement: Ketone Ester Elite endurance Nutrition Drink;Other: Stool SampleUniversity of FloridaNULLRecruiting40 Years75 YearsAll15N/AUnited States
145EUCTR2018-003028-35-GB
(EUCTR)
04/09/201915/11/2019A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease.A randomised, double blind, parallel group, placebo controlled, Phase 3 trial of exenatide once weekly over 2 years as a potential disease modifying treatment for Parkinson's disease. - Phase 3 Trial of exenatide for Parkinson’s disease Parkinson's disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
University College London Comprehensive Clinical Trial UnitNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT03959540
(ClinicalTrials.gov)
September 201923/4/2019Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseA Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Levodopa (L-DOPA) + Standard careBial - Portela C S.A.NULLNot yet recruiting75 YearsN/AAll100NULL
147NCT04054960
(ClinicalTrials.gov)
September 20199/8/2019A Trial of tPCS on Parkinson's Disease OFF StateA Trial of tPCS on Parkinson's Disease OFF StateParkinson DiseaseDevice: Active tPCS;Device: Sham tPCS;Drug: Levodopa tabletWestern University, CanadaNULLNot yet recruiting40 Years80 YearsAll15N/ACanada
148NCT04006210
(ClinicalTrials.gov)
August 27, 201930/6/2019A Clinical Trial Investigating the Efficacy, Safety and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless).A Multicenter, Randomized, Active-controlled, Double-blind, Double-dummy, Parallel Group Clinical Trial, Investigating the Efficacy, Safety, and Tolerability of Continuous Subcutaneous ND0612 Infusion in Comparison to Oral IR-LD/CD in Subjects With Parkinson's Disease Experiencing Motor Fluctuations (BouNDless)Parkinson's DiseaseCombination Product: ND0612 Solution for SC infusion;Combination Product: Placebo for SC infusion;Drug: Carbidopa and Levodopa 25mg/100mg;Drug: Placebo for Carbidopa and Levodopa 25mg/100mgNeuroDerm Ltd.NULLRecruiting30 Years80 YearsAll380Phase 3United States;Austria;Belgium;Czechia;France;Hungary;Israel;Italy;Netherlands;Poland;Portugal;Russian Federation;Slovakia;Spain;Ukraine;United Kingdom
149NCT04070495
(ClinicalTrials.gov)
August 27, 201926/8/2019A Drug Interaction Study of KW-6356 and Clarithromycin or RifampicinA Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin (A Drug Interaction Study With a CYP3A4/5 Inhibitor or Inducer)Parkinson's DiseaseDrug: KW-6356;Drug: Clarithromycin;Drug: RifampicinKyowa Kirin Co., Ltd.NULLCompleted20 Years44 YearsMale20Phase 1Japan
150EUCTR2018-003941-41-PL
(EUCTR)
23/08/201903/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2018-002234-21-ES
(EUCTR)
21/08/201911/06/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
152EUCTR2018-002144-85-BE
(EUCTR)
20/08/201924/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan
153ChiCTR1900025372
2019-08-182019-08-25Digital assessment of Parkinson's diseaseQuantitative evaluation of drug response test in patients with Parkinson's disease and the influence of rehabilitation intervention on the evaluation of drug response and the exploration of related mechanisms Parkinson's disease1:rehabilitation;1:take levodopa;30:Wear wearable devices;Tianjin Huanhu HospitalNULLRecruitingBoth1:30;1:30;30:30;China
154NCT04062526
(ClinicalTrials.gov)
August 14, 201914/8/2019Evaluation of Neuroinflammation in Parkinson's Disease Using 18F-NOS PET/CTEvaluation of in Vivo Neuroinflammation in Parkinson's Disease Using 18F-NOS Positron Emission Tomography (PET/CT)Parkinson Disease;Healthy VolunteerDrug: [18F]NOSUniversity of PennsylvaniaNULLRecruiting18 Years75 YearsAll30Early Phase 1United States
155EUCTR2018-003941-41-ES
(EUCTR)
13/08/201911/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2018-003941-41-GB
(EUCTR)
09/08/201916/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
157NCT03881371
(ClinicalTrials.gov)
August 1, 201918/3/2019A Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of LevodopaA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide, as add-on Therapy, in Idiopathic Chinese Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Stable Doses of LevodopaParkinson DiseaseDrug: Safinamide;Other: PlaceboZambon SpANULLRecruiting18 YearsN/AAll306Phase 3China
158JPRN-UMIN000037421
2019/08/0101/08/2019A study on improvement of cognitive function by istradefylline for parkinson diseaseAn open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease Parkinson diseasePrescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months.
The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26.
Ichinomiya Nishi HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
159ChiCTR1900023725
2019-08-012019-06-09Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS)Study for the Role of Butylphthalide in Delaying the progression of Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS) Parkinson's disease (PD), Vascular Parkinson's disease (VP) and Parkinsonism-plus syndrome (PPS)PD-Placebo:Placebo;PD-Butylphthalide:Butylphthalide;VP-Placebo:Placebo;VP-Butylphthalide:Butylphthalide;MSA-Placebo:Placebo;MSA-Butylphthalide :Butylphthalide ;PSP-Placebo:Placebo;PSP-Butylphthalide:Butylphthalide;Zhujiang Hospital of Southern Medical UniversityNULLPending1880MalePD-Placebo:50;PD-Butylphthalide:50;VP-Placebo:50;VP-Butylphthalide:50;MSA-Placebo:50;MSA-Butylphthalide :50;PSP-Placebo:50;PSP-Butylphthalide:50;China
160JPRN-UMIN000037422
2019/08/0101/08/2019An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson diseaseAn open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease Parkinson diseasePrescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months.Ichinomiya Nishi HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2018-003941-41-HU
(EUCTR)
30/07/201901/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
162EUCTR2018-002144-85-GB
(EUCTR)
29/07/201913/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom
163NCT04056689
(ClinicalTrials.gov)
July 23, 201912/8/2019Study to Evaluate DNL151 in Subjects With Parkinson's DiseaseA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL151 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: DNL151;Drug: PlaceboDenali Therapeutics Inc.NULLActive, not recruiting30 Years75 YearsAll34Phase 1United States;Belgium;Netherlands;United Kingdom
164EUCTR2018-003289-15-PL
(EUCTR)
19/07/201907/05/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine chydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
165EUCTR2018-002144-85-ES
(EUCTR)
11/07/201912/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2018-002144-85-DK
(EUCTR)
08/07/201914/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Australia;Denmark;Netherlands;United Kingdom;Japan
167EUCTR2018-003941-41-EE
(EUCTR)
04/07/201929/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
168EUCTR2018-003289-15-DK
(EUCTR)
02/07/201914/03/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Denmark;Australia;Bulgaria;Germany;New Zealand
169ChiCTR1900021708
2019-07-012019-03-05Study for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphiStudy for the brain network mechanism of pramipexole in the treatment of tremor-type PD patients based on DRD3 Ser9Gly polymorphism Parkinson's DiseaseHealthy control group:No;tremor-dominant phenotype PD patients group:pramipexole;Department of Neurology, Brain Hospital Affiliated to Nanjing Medical UniversityNULLPending5070BothHealthy control group:80;tremor-dominant phenotype PD patients group:80;China
170NCT03977441
(ClinicalTrials.gov)
July 201912/5/2019the Efficacy and Safety of Agomelatine in the Patients With Parkinson's DiseaseA Multicenter, Randomized, Double-blind, Placebo-controlled Study: Evaluation of the Efficacy and Safety of Agomelatine in the Treatment of Sleep Disorders and Depression in Patients With Parkinson's DiseaseParkinson Disease;Depression;Sleep Disorders;Circadian Rhythm DisordersDrug: Agomelatine or PIaceboSecond Affiliated Hospital of Soochow UniversityNULLNot yet recruiting30 Years75 YearsAll240Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2018-003219-23-GB
(EUCTR)
28/06/201904/06/2019CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease)CHIEF-PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson’s Disease): A phase 3 randomised double-blind placebo-controlled trial of rivastigmine to prevent falls in Parkinson’s disease - CHIEF-PD This trial will investigate the effectiveness of Rivastigmine on prevention of falls in patients with Parkinson's disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h
Product Name: Rivastigmin Luye Transdermal Patches - 4.6mg/24h
Product Code: N/A
INN or Proposed INN: Rivastigmine
Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below)
Trade Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h
Product Name: Rivastigmine Luye Transdermal Patch- 9.5mg/24h
INN or Proposed INN: Rivastigmine
Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below)
Product Name: Rivastigmine transdermal system 13.3 mg/24 h
Product Code: RIV-TDS 13.3 mg/24 h
INN or Proposed INN: Rivastigmine
Other descriptive name: Ethylmethylcarbamic acid 3-[(1S)-1-(dimethylamino)ethyl]phenyl ester (**See other 2 names below)
University of BristolNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Kingdom
172EUCTR2018-003289-15-ES
(EUCTR)
26/06/201927/06/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Denmark;Germany
173EUCTR2018-003337-15-HU
(EUCTR)
18/06/201912/04/2019A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease Early Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sun Pharma Advanced Research Company (SPARC) LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
504Phase 2United States;Hungary;Slovakia;Poland;Spain;India
174EUCTR2018-002234-21-CZ
(EUCTR)
14/06/201930/05/2019 An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
175NCT03938922
(ClinicalTrials.gov)
June 13, 201918/4/2019A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease DementiaA Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.Parkinson Disease;DementiaDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLActive, not recruiting30 Years90 YearsAll40Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT03939559
(ClinicalTrials.gov)
June 10, 20193/5/2019The Efficiency of Home Based Dual Task Training in Parkinson DiseaseThe Efficiency of Home Based Dual Task Training in Parkinson DiseaseParkinson DiseaseProcedure: Static, dynamic and functional balance exercises;Procedure: Static, dynamic and functional balance exercises with dual taskIstanbul University-CerrahpasaNULLNot yet recruiting30 Years80 YearsAll60N/ANULL
177EUCTR2018-003337-15-SK
(EUCTR)
05/06/201926/04/2019A study to look at how safe, and effective the study drug K0706 is in patients with early Parkinson's Disease.A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson’s Disease Early Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Product Code: K0706
INN or Proposed INN: K0706
Other descriptive name: K0706
Sun Pharma Advanced Research Company (SPARC) LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
504Phase 2United States;Hungary;Slovakia;Poland;Spain;India
178NCT04389762
(ClinicalTrials.gov)
June 4, 201930/4/2020PS128 May Improve Off Duration on Parkinson's DiseaseLactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot StudyParkinson DiseaseDietary Supplement: daily ingestion of Lactobacillus plantarum PS128Professor Lu Neurological ClinicNULLCompleted40 Years80 YearsAll60N/ATaiwan
179JPRN-UMIN000036952
2019/06/0404/06/2019A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. - A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients. Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others.18F-FDOPA, 11C-Raclopride PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
180EUCTR2018-003289-15-HU
(EUCTR)
04/06/201905/04/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Denmark;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181ChiCTR1900022534
2019-06-012019-04-15Efficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trialEfficacy of entacapone and pramipexole for non-motor symptoms of Parkinson’s disease: a prospective randomized controlled trial non-motor symptoms of Parkinson’s diseaseentacapone group:Patients in the entacapone group will be administered entacapone (Novartis; import drug registration certificate number: H20160680), 10 times per day, 200 mg each time, for 3 weeks. ;pramipexole group:Patients in the pramipexole group will be administered pramipexole (Boehringer-Ingelheim; import drug registration certificate number: 20140918) , 3 times per day, 1 mg each time, for 3 weeks.;Geriatric Hospital of HainanNULLPending4075Bothentacapone group:194;pramipexole group:194;N/AChina
182JPRN-UMIN000036908
2019/05/3131/05/2019A dementia study by 11C-PiB, 18F-FDG PETA dementia study by 11C-PiB, 18F-FDG PET - A dementia study by 11C-PiB, 18F-FDG PET mild cognitive impairment, Alzheimer's disease, dementia with Lewy bodies, cerebrovascular dementia, frontotemporal degeneration, progressive supranuclear palsy, corticobasal degeneration, Parkinson's disease with dementia, other neurodegenerative diseases, normal pressure hydrocephalus, hypoxic encephalopathy, brain tumor, brain injury etc.11C-PiB, 18F-FDG PETNagoya City Rehabilitation AgencyNULLRecruiting20years-oldNot applicableMale and Female150Not applicableJapan
183NCT03971617
(ClinicalTrials.gov)
May 29, 201930/5/2019Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Hydrogen;Drug: Placebo oral tabletStony Brook UniversityNULLRecruiting40 Years80 YearsAll70Phase 2;Phase 3United States
184NCT03970798
(ClinicalTrials.gov)
May 22, 201923/5/2019A Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or RosuvastatinA Drug Interaction Study of KW-6356 With Midazolam, Caffeine, or RosuvastatinParkinson's DiseaseDrug: Midazolam;Drug: Caffeine;Drug: Rosuvastatin;Drug: KW-6356Kyowa Kirin Co., Ltd.NULLCompleted20 Years44 YearsMale50Phase 1Japan
185NCT03693872
(ClinicalTrials.gov)
May 15, 20191/10/2018Evaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsEvaluation of the Nonmotor Symptomatology of Parkinsonian Patients Treated With Two Strategies Related to Apomorphine Pump Therapy in French HospitalsParkinson DiseaseDrug: Apomorphine;Drug: Dopaminergic Agonist + ApomorphineRennes University HospitalNULLRecruiting18 YearsN/AAll42N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03552068
(ClinicalTrials.gov)
May 15, 201917/5/2018Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease:Study of Clonidine Efficacy for the Treatment of Impulse Control Disorders in Parkinson's Disease: A Pilot Double Blind Randomized TrialParkinson's Disease;Mpulse Control DisordersDrug: placebo;Drug: ClonidineHospices Civils de LyonNULLRecruiting30 Years80 YearsAll38Phase 2France
187EUCTR2018-003289-15-AT
(EUCTR)
15/05/201922/03/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled, Parallel-group Study of TD-9855 inTreating Symptomatic Neurogenic Orthostatic Hypotension inSubjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Czechia;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
188NCT03970239
(ClinicalTrials.gov)
May 13, 20196/5/2019Serotonin in Impulse Control Disorders in Parkinson's DiseaseRole of the Serotoninergic System in Impulse Control Disorders in Parkinson's DiseaseParkinson Disease;Impulse Control DisordersDrug: Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin);Drug: Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)Hospices Civils de LyonNULLRecruiting30 Years80 YearsAll45N/AFrance
189NCT03958708
(ClinicalTrials.gov)
May 13, 201914/5/2019Modulation of Gut Microbiota by Rifaximin in PD PatientsModulation of Gut Microbiota by Rifaximin in PD PatientsParkinson Disease;InflammationDrug: Rifaximin 550 MGTaipei Medical University Shuang Ho HospitalNULLRecruiting45 Years70 YearsAll20Phase 1;Phase 2Taiwan
190EUCTR2018-003289-15-GB
(EUCTR)
08/05/201928/12/2018This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF)A Phase 3, 4-week, Multicenter, Randomized, Double-blind,Placebo-controlled,Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Sequoia study Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
188Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT04566341
(ClinicalTrials.gov)
May 4, 201911/8/2020Study of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's DiseaseStudy of Gastrointestinal Dysfunction and Enteric Neural Pathology in Patients With Parkinson's DiseaseParkinson Disease;ParkinsonDevice: OCT - TCEMassachusetts General HospitalNULLRecruiting40 Years85 YearsAll20United States
192EUCTR2019-000247-27-FR
(EUCTR)
02/05/201905/03/2019Study to demonstrate an at least equivalent performance of a new test in brain imaging test compared to the reference examination to establish the differential diagnosis between Parkinson's Disease and Essential Tremor.Non-inferiority study of the molecular imaging of dopamine transporters using [123I]-FP/CIT-SPECT and [18F] LBT-999-PET to distinguish between Parkinson’s Disease and Essential Tremor. - DATTEP Patients suffering from an essential tremor or with Parkinson's disease.
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10015496;Term: Essential tremor;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: DaTSCAN 74 MBq/ml solution for injection
Product Code: [18F] LBT-999
ZIONEXANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
112Phase 3France
193ChiCTR1900022715
2019-05-012019-04-23Accurate treatment under the multidisciplinary cooperative diagnosis and treatment model of Parkinson's diseaseAccurate treatment under the multidisciplinary cooperative diagnosis and treatment model of Parkinson's disease Parkinson's DiseaseAnteversion group:DBS;Balance dysfunction group:DBS;Gait abnormality group:DBS;Tianjin Huanhu HospitalNULLRecruitingBothAnteversion group:40;Balance dysfunction group:40;Gait abnormality group:40;N/AChina
194NCT03781167
(ClinicalTrials.gov)
April 29, 201918/12/2018A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France
195NCT03899324
(ClinicalTrials.gov)
April 26, 201929/3/2019Evaluation of the Efficacy and Safety of Bumetanide in Parkinson's DiseaseA Randomized Double-blind Placebo-controlled Multicenter Proof-of-concept Trial to Assess the Efficacy and Safety of Bumetanide in Parkinson's DiseaseParkinson DiseaseDrug: Bumetanide white, oblong, scored tablet;Drug: Placebo white, oblong, scored tabletB&A TherapeuticsNULLRecruiting40 Years80 YearsAll40Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196JPRN-JapicCTI-194763
22/4/201920/05/2019Safety and PK study of LY03003An open-label study in Japanese patients with Parkinson's disease to evaluate the safety, pharmacokinetics and preliminary efficacy of LY03003 following intramuscular injections and its comparative bioavailability to Rotigotine transdermal patch. Parkinson's DiseaseIntervention name : Rotigotine
INN of the intervention : Rotigotine
Dosage And administration of the intervention : LY03003 IM injections 14, 28 and 56 mg/week.
Control intervention name : Rotigotine
INN of the control intervention : Rotigotine
Dosage And administration of the control intervention : Rotigotine transdermal patch applications 4.5, 9 and 18 mg/day.
Shandong Luye Pharmaceutical Co., Ltd./CMIC Co., Ltd.NULLcomplete20BOTH32Phase 1Japan
197EUCTR2018-002233-37-DE
(EUCTR)
17/04/201908/01/2019Evaluate the safety and efficacy of IPX203 carbidopa-levodopa extended release capsules compared to carbidopa-levodopa immediate release tablets in patients with Parkinson’s with motor fluctuations.A randomized controlled study to compare the safety and efficacy of IPX203 with immediate-release carbidopa-levodopa in Parkinson's disease patients with motor fluctuations. Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Carbidopa and Levodopa Tablets, USP
Product Name: IR CD-LD (carbidopa-levodopa) tablets
Product Code: IR CD-LD
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
510Phase 3United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy
198NCT04420910
(ClinicalTrials.gov)
April 15, 20194/6/2020Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's DiseaseInvestigation of Non-motor Symptoms, Balance, Muscle Strength, and Functional Mobility in Patients With Parkinson's DiseaseParkinson Disease;Balance;Muscle Strength;Mobility;Non-motor SymptomsOther: Non-Motor Symptoms;Other: Balance;Other: Lower Limb Strength;Other: Functional mobilityAnkara Yildirim Beyazit UniversityNULLCompleted50 Years65 YearsAll44Turkey
199EUCTR2018-003289-15-EE
(EUCTR)
11/04/201930/01/2019This study will look at whether an investigational drug called TD-9855 works and how safe it is for treating symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA) or pure autonomic failure (PAF) A Phase 3, 4-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects With Primary Autonomic Failure - Phase 3 Clinical Effect of TD-9855 for Treating snOH in Subjects With Primary Autonomic Failure Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
188Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
200NCT03841604
(ClinicalTrials.gov)
April 9, 201930/1/2019Effect of Safinamide on Parkinson's Disease Related Chronic PainA Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Safinamide 100mg Once Daily, as add-on Therapy, in Idiopathic Parkinson's Disease (PD) Patients With Motor Fluctuations and PD Related Chronic PainIdiopathic Parkinson DiseaseDrug: Safinamide Methanesulfonate;Drug: Safinamide methanesulfonate matching placeboZambon SpANULLRecruiting30 YearsN/AAll177Phase 4Austria;France;Germany;Italy;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT03775096
(ClinicalTrials.gov)
April 4, 20199/12/2018Adrenergic Blockers for Cardiac Changes in Early Parkinson's DiseaseThe Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's DiseaseREM Sleep Behavior Disorder;Pre-motor Parkinson Disease;Symptomatic Parkinson DiseaseDrug: CarvedilolMichele Tagliati, MDNULLRecruiting30 Years75 YearsAll15Phase 2United States
202EUCTR2016-000657-12-GR
(EUCTR)
04/04/201911/01/2019A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: -
Other descriptive name: Genz-682452-AU
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: -
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
203NCT03877510
(ClinicalTrials.gov)
April 3, 201912/3/2019Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor FluctuationsAn Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mgImpax Laboratories, LLCNULLEnrolling by invitation40 YearsN/AAll300Phase 3United States;Czechia;France;Germany;Italy;Spain;United Kingdom
204ChiCTR1800015757
2019-04-012018-04-18Value of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's diseaseValue of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's disease Parkinson's DiseaseGold Standard:PD diagnostic criteria made by MDS in 2016;Index test:reduced uptake in salivery gland and myocardium in I-131-MIBG scintigraphic imaging;Tongji hospital, Tongji UniversityNULLPendingBothTarget condition:30;Difficult condition:30China
205NCT03858270
(ClinicalTrials.gov)
April 1, 20192/10/2018Inhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, MemantineInhibition of a-synuclein Cell-cell Transmission by NMDAR Blocker, MemantineParkinson DiseaseDrug: Memantine;Other: PlaceboWayne State UniversityNULLRecruiting45 Years85 YearsAll50Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206JPRN-jRCTs051180214
29/03/201927/03/2019The usefulness of flutemetamol for diagnostic imaging of neurogenerative diseaseThe usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease - The usefulness of brain amyloid image using flutemetamol and glucose metabolism for the neurogenerative disease Alzheimer's disease,Dementia with Lewy Bodies,Parkinson's syndrome,Frontotemporal lober degeneration
Alzheimer's disease, Dementia with Lewy Bodies, Parkinson's syndrome, Frontotemporal lober degeneration, Parkinson's disease, Mild cognitive impairment, Non-Alzheimer's disease, Progressive aphasia, Neurodegenerative disease, Cerebral corticobasal degeneration, Progressive supranuclear palsy
Amyloid PET: Given the flutemetamol (3mL) intravenously
FDG-PET:Given the FDG scanR (3mL) intravenously
Itoh YoshiakiNULLRecruitingAges 20 and overN/ABoth100N/AJapan
207NCT03922711
(ClinicalTrials.gov)
March 26, 201917/4/2019A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's DiseaseA Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)Parkinson DiseaseDrug: Pridopidine;Drug: PlaceboPrileniaNULLTerminated30 Years85 YearsAll23Phase 2United States
208NCT04064983
(ClinicalTrials.gov)
March 14, 201919/8/2019Individual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells for Parkinson's DiseaseIndividual Patient Expanded Access IND of Hope Biosciences Autologous Adipose-derived Mesenchymal Stem Cells (HB-adMSCs) for Parkinson's DiseaseParkinson DiseaseDrug: HB-adMSCsHope BiosciencesNULLNo longer available18 YearsN/AAllUnited States
209NCT03716570
(ClinicalTrials.gov)
March 12, 201922/10/2018A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Participants With Parkinson's DiseaseA Multicenter, Blinded, Placebo-Controlled, Randomized, Single and Multiple-Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Japanese Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: BIIB054;Drug: PlaceboBiogenNULLActive, not recruiting40 Years80 YearsAll24Phase 1Japan
210ChiCTR1900021760
2019-03-092019-03-08Effect-site concentration of remifentanil for I-gel insertion in male patients with Parkinson’s disease undergoing deep brain stimulator implantation during target-controlled infusion of propofolEffect-site concentration of remifentanil for I-gel insertion in male patients with Parkinson’s disease undergoing deep brain stimulator implantation during target-controlled infusion of propofol Parkinson’s diseaseParkinson’s disease:propofol and remifentanil;Non-Parkinson’s disease:propofol and remifentanil;The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of ChinaNULLRecruiting4064MaleParkinson’s disease:25;Non-Parkinson’s disease:25;N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT03816020
(ClinicalTrials.gov)
March 9, 20197/12/2018NAD-supplementation in Drug naïve Parkinson's DiseaseNAD-PARK: A Double-blinded Randomized Pilot Trial of NAD-supplementation in Drug naïve Parkinson's DiseaseParkinson Disease;Neurodegenerative DiseasesDietary Supplement: Nicotinamide Riboside;Other: PlaceboHaukeland University HospitalNULLCompleted18 YearsN/AAll30N/ANorway
212EUCTR2017-005170-19-FI
(EUCTR)
06/03/201907/12/2018A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension StudyA Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Renishaw Neuro Solutions Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
213NCT03887884
(ClinicalTrials.gov)
March 5, 20191/3/2019Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301;Drug: SinemetAcorda TherapeuticsNULLCompleted30 Years85 YearsAll23Phase 1United States
214NCT03820037
(ClinicalTrials.gov)
March 201925/1/2019Relative Bioavailability and Bioequivalence of OpicaponeA Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy SubjectsParkinson DiseaseDrug: Ongentys;Drug: BIA 9-1067 (test)Bial - Portela C S.A.NULLNot yet recruiting18 Years55 YearsAll45Phase 1United Kingdom
215NCT03830528
(ClinicalTrials.gov)
February 26, 20193/2/2019A Study of Single and Multiple Doses of KW-6356 in Healthy SubjectsA Phase I Study of KW-6356 in Japanese and Caucasian Healthy AdultsParkinson's DiseaseDrug: KW-6356 Low Dose;Drug: KW-6356 Middle Dose;Drug: KW-6356 High Dose;Drug: KW-6356 X Dose;Drug: KW-6356 Y Dose;Drug: PlaceboKyowa Kirin Co., Ltd.NULLCompleted20 Years44 YearsMale48Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03845387
(ClinicalTrials.gov)
February 26, 201915/2/2019A Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.A Phase II Clinical Study of KDT-3594 in Patients With Early Parkinson's Disease.Parkinson DiseaseDrug: KDT-3594;Drug: PramipexoleKissei Pharmaceutical Co., Ltd.NULLActive, not recruiting20 Years79 YearsAll100Phase 2Japan
217NCT03655236
(ClinicalTrials.gov)
February 18, 201918/8/2018PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of K0706 in Subjects With Early Parkinson's DiseaseEarly Parkinson DiseaseDrug: K0706;Other: placeboSun Pharma Advanced Research Company LimitedNULLRecruiting50 YearsN/AAll504Phase 2United States;Hungary;Poland;Slovakia;Spain
218NCT03413384
(ClinicalTrials.gov)
February 15, 20198/1/2018To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaA Randomized, Double Blinded, Placebo-controlled Phase II Study to Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease DementiaParkinson's Disease DementiaDrug: Ceftriaxone;Other: PlaceboBrainX CorporationNULLRecruiting50 Years80 YearsAll106Phase 2Taiwan
219NCT03815071
(ClinicalTrials.gov)
February 1, 201921/1/2019A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem CellsClinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's DiseaseParkinson DiseaseDrug: Ips-nsc cellsAllife Medical Science and Technology Co., Ltd.The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital;Henan Provincial People's Hospital;Beijing HospitalNot yet recruiting18 Years60 YearsAll10Early Phase 1NULL
220NCT03790670
(ClinicalTrials.gov)
January 30, 201918/12/2018Biomarker Assessments of Leukine During Treatment of Parkinson's DiseaseSafety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot StudyParkinson DiseaseDrug: sargramostimUniversity of NebraskaNULLRecruiting35 Years85 YearsAll10Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2017-003458-18-SE
(EUCTR)
23/01/201910/12/2018A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaA randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia Parkinson's disease dyskinesia
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Integrative Research Laboratories AB (IRLAB)NULLNot Recruiting Female: yes
Male: yes
74Phase 2Sweden
222EUCTR2017-002426-20-AT
(EUCTR)
22/01/201903/12/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain.
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Zambon SpANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
177Phase 4Spain;Austria
223EUCTR2018-002877-23-AT
(EUCTR)
21/01/201907/12/2018Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study.Oxytocin and social attention in healthy controls and patients with Parkinson's disease. A randomised, double-blind, placebo-controlled, crossover eye tracking study. - Oxytocin in healthy controls and PD Social functioning in Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Syntocinon 40 IU/ml nasal spray
INN or Proposed INN: Synthetic Oxytocin
Other descriptive name: OXYTOCIN SYNTHETIC
Abteilung für Neurologie der Medizinischen Universität InnsbruckNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: yes
76Phase 2Austria
224NCT03826134
(ClinicalTrials.gov)
January 17, 201930/1/2019A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy SubjectsInterventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy SubjectsParkinson DiseaseDrug: [11C]PXT012253H. Lundbeck A/SNULLCompleted20 Years50 YearsAll7Early Phase 1Sweden
225NCT04620863
(ClinicalTrials.gov)
January 15, 201926/10/2020TRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASETRANSCRANIAL DIRECT CURRENT STIMULATION (t-DCS) AS ADD-ON TO NEUROREHABILITATION OF PISA SYNDROME IN PARKINSON DISEASE: A RANDOMIZED CONTROLLED TRIALParkinson Disease;Pisa SyndromeOther: t-DCS group;Other: Sham groupIRCCS National Neurological Institute C. Mondino FoundationNULLCompleted18 Years80 YearsAll30N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226JPRN-UMIN000035602
2019/01/1121/01/2019Hydrogen gas inhalation randomized double blinded trial for Parkinson's diseaseHydrogen gas inhalation randomized double blinded trial for Parkinson's disease - Hydrogen gas inhalation randomized double blinded trial for Parkinson's disease Parkinson's diseasehydrogen gas16 weeks inhalation
two times of the inhalation for 60 minutes per day
8 weeks obsebation after the inhalation
placebo gas
16 weeks inhalation
two times of the inhalation for 60 minutes per day
8 weeks obsebation after the inhalation
Juntendo University Koshigaya HospitalNULLComplete: follow-up complete40years-old80years-oldMale and Female20Not selectedJapan
227NCT03638479
(ClinicalTrials.gov)
January 8, 201913/8/2018Utilizing Smart Devices to Identify New Phenotypical Characteristics in Movement DisordersUtilizing Smart Devices to Identify New Phenotypical Characteristics in Movement DisordersParkinson Disease;Essential Tremor;Movement Disorders;Parkinson's Syndrome;Atypical ParkinsonismOther: Data CaptureWestfälische Wilhelms-Universität MünsterNULLRecruiting18 YearsN/AAll500Germany
228NCT03659682
(ClinicalTrials.gov)
January 2, 20193/9/2018GLP1R in Parkinson's DiseaseEffect of GLPIR Stimulation on Neuroprotection and Inflammation in Parkinson's DiseaseParkinson DiseaseDrug: SemaglutideOslo University HospitalNULLNot yet recruiting40 Years75 YearsAll120Phase 2NULL
229NCT03727295
(ClinicalTrials.gov)
January 1, 201930/10/2018Idebenone Treatment of Early Parkinson's DiseasesymptomsA Multicenter, Randomized, Double-blind, Placebo-controlled Study of Idebenone in the Treatment of Early-stage Parkinson's Disease With Motor and Non-motor SymptomsOxidative Stress is an Important Cause of Parkinson's DiseaseDrug: Idebenone/placeboSecond Affiliated Hospital of Soochow UniversityQilu Pharmaceutical Co., Ltd.Not yet recruiting30 Years80 YearsAll180Phase 4NULL
230ChiCTR1800019942
2018-12-312018-12-09A Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s DiseaseA Multicenter Randomized Controlled Trial for Effect of Zishen Pingchan Granules Combined with Pramipexole in the treatment of Depression in Parkinson’s Disease Parkinson’s DiseaseExperimental group:Zishen Pingchan Granules combined with Pramipexole;Control group:Zishen Pingchan Granules placebo combined with Pramipexole;The Affiliated Brain Hospital of Nanjing Medical University( Nanjing Brain Hospital)NULLPending3085BothExperimental group:150;Control group:150;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT03391882
(ClinicalTrials.gov)
December 19, 20182/1/2018A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor FluctuationsMotor OFF Episodes Associated With Parkinson's DiseaseDrug: APL-130277;Drug: subcutaneous apomorphineSunovionNULLRecruiting18 YearsN/AAll106Phase 3Austria;France;Germany;Italy;Spain;United Kingdom
232NCT03781791
(ClinicalTrials.gov)
December 10, 201827/11/2018Orally Administered ENT-01 for Parkinson's Disease-Related Constipation (KARMET)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate Safety, Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease-Related Constipation (KARMET)Constipation;Parkinson DiseaseDrug: Active Investigational Treatment ENT-01;Drug: Placebo TreatmentEnterin Inc.NULLActive, not recruiting30 Years90 YearsAll152Phase 2United States
233NCT03710707
(ClinicalTrials.gov)
December 4, 201815/10/2018Study to Evaluate DNL201 in Subjects With Parkinson's DiseaseA Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: DNL201;Drug: PlaceboDenali Therapeutics Inc.NULLCompleted30 Years80 YearsAll29Phase 1United States
234NCT03639064
(ClinicalTrials.gov)
December 20184/7/2018Cannabis Oil for Pain in Parkinson's DiseaseA Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's DiseaseParkinson DiseaseDrug: Cannabis OilUniversity Health Network, TorontoParkinson Society CanadaUnknown status18 YearsN/AAll15Phase 2NULL
235NCT03942172
(ClinicalTrials.gov)
November 27, 20186/5/2019Treatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance GlassesTreatment of Balance Disorders in Parkinson's Patients Using SpotOn Balance GlassesParkinson DiseaseDevice: SpotOn balance glassesSpotOn Therapeutics Ltd.NULLSuspended30 YearsN/AAll50N/AIsrael
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236NCT03822364
(ClinicalTrials.gov)
November 26, 201818/12/2018Staccato Apomorphine Single and Multi Dose PKA Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5Alexza Pharmaceuticals, Inc.NULLCompleted18 Years60 YearsAll56Phase 1Netherlands
237NCT03823638
(ClinicalTrials.gov)
November 20, 201820/11/2018Safety, Tolerability and Effects of Mannitol in Parkinson's DiseaseA Phase II Single Center, Randomized, Double Blind and Placebo Controlled Study Assessing the Safety, Tolerability and Effects of Progressively Increased Dose of Oral Mannitol in Parkinson's DiseaseParkinson DiseaseDietary Supplement: Oral D-Mannitol of PlaceboHadassah Medical OrganizationNULLRecruiting40 Years75 YearsAll60Phase 2Israel
238NCT03733561
(ClinicalTrials.gov)
November 9, 20186/11/2018A Study to Assess Pharmacokinetic Profiles of LY03003 and NeuproA Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersParkinson DiseaseDrug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal PatchLuye Pharma Group Ltd.NULLRecruiting18 Years45 YearsAll40Phase 1United States
239EUCTR2018-001887-46-GB
(EUCTR)
08/11/201819/06/2019Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study'A Phase II, Placebo Controlled, Double Blind, Randomised Clinical Trial to assess the safety and tolerability Of 30mg/kg daily Ursodeoxycholic Acid (UDCA) in Patients with Parkinson’s Disease (PD) - Trial of Ursodeoxycholic Acid (UDCA) for PD. The 'UP-study' Parkinson’s disease (PD)
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sheffield Teaching Hospitals NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
30Phase 2United Kingdom
240NCT03670953
(ClinicalTrials.gov)
November 6, 201812/9/2018A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients With Motor FluctuationsA Randomized Controlled Study to Compare the Safety and Efficacy of IPX203 With Immediate-Release Carbidopa-Levodopa in Parkinson's Disease Patients With Motor FluctuationsParkinson's Disease (Disorder)Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placeboImpax Laboratories, LLCNULLRecruiting40 YearsN/AAll510Phase 3United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT04629404
(ClinicalTrials.gov)
November 5, 20185/11/2020A Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of LY03003 in Early PD PatientsA Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Pharmacodynamics/Pharmacokinetics and Safety of Multiple Intramuscular Doses of LY03003 in Patients With Early Parkinson's DiseaseParkinson DiseaseDrug: LY03003;Drug: PlaceboLuye Pharma Group Ltd.NULLCompleted30 YearsN/AAll32Phase 1China
242NCT03069911
(ClinicalTrials.gov)
November 1, 201828/2/2017Trial of OnabotulinumtoxinA for Depression in Parkinson DiseaseRandomized Controlled Trial of OnabotulinumtoxinA for Depression in Parkinson DiseaseParkinson Disease;DepressionBiological: OnabotulinumtoxinA;Biological: ControlJohns Hopkins UniversityNULLTerminated18 Years95 YearsAll3Phase 1United States
243NCT03727139
(ClinicalTrials.gov)
November 1, 201830/10/2018Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term SafetyAZILECT Tablets Special Drug Use-Results Survey Survey on Long-term SafetyParkinson's DiseaseDrug: RasagilineTakedaNULLActive, not recruitingN/AN/AAll1021Japan
244JPRN-JapicCTI-184181
01/11/201830/10/2018Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term SafetyAZILECT Tablets Special Drug Use-Results Survey Survey on Long-term Safety Parkinson's diseaseIntervention name : Rasagiline
INN of the intervention : rasagiline
Dosage And administration of the intervention : Rasagiline 1 milligram (mg), orally, once daily for up to 24 months. Participants received interventions as part of routine medical care.
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
TAKEDA PHARMACEUTICAL COMPANY LTD.NULLcompleteBOTH1021NAJapan
245EUCTR2016-002033-30-NL
(EUCTR)
31/10/201815/11/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2017-003415-19-ES
(EUCTR)
31/10/201820/08/2018A Clinical Study in Parkinson’s Disease Patients With Moderate to Severe Abnormal Movements to See If JM-010 is Effective and Safe/Tolerable.A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study in Parkinson’s Disease Patients With Moderate to Severe Dyskinesia to Assess the Efficacy and Safety/Tolerability of Two Dose Combinations Of JM-010 Parkinson’s Disease Patients With Moderate to Severe Dyskinesia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: JM-010
Product Code: JM-010
INN or Proposed INN: Buspirone hydrochloride
INN or Proposed INN: Zolmitriptan
Product Name: JM-010
Product Code: JM-010
INN or Proposed INN: Buspirone hydrochloride
INN or Proposed INN: Zolmitriptan
Contera PharmaNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Spain;Germany
247ChiCTR1800017949
2018-10-302018-08-24Clinical study for the effect of the combination of Shudipingchan prescription and Monoamine oxidase inhibitor on improving early PD symptoms and delaying the progression of the diseaseClinical study for the effect of the combination of Shudipingchan prescription and Monoamine oxidase inhibitor on improving early PD symptoms and delaying the progression of the disease Parkinson's diseaseGroup 1:Selegiline and Shudipingchan granule;Group 2:Selegiline and simulant TCM granule;Longhua Hospital Shanghai University of Traditional Chinese MedicineNULLPending3085BothGroup 1:72;Group 2:72;China
248ChiCTR1800018017
2018-10-302018-08-27Clinical study for the effect of the combination of Shudipingchan prescription and Monoamine oxidase inhibitor on improving early Parkinson‘s Disease symptoms and delaying the progression of the diseaseClinical study for the effect of the combination of Shudipingchan prescription and Monoamine oxidase inhibitor on improving early Parkinson‘s Disease symptoms and delaying the progression of the disease Parkinson's diseaseTreatment group:Selegiline+Shudipingchan granule;Control group:Selegiline+TCM simulant;Longhua Hospital Shanghai University of Traditional Chinese MedicineNULLPending3085BothTreatment group:92;Control group:92;China
249EUCTR2017-002426-20-ES
(EUCTR)
19/10/201820/08/2018Effect of Safinamide on Parkinson’s Disease Related Chronic PainA randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of safinamide 100 mg once daily, as add-on therapy, in idiopathic Parkinson’s Disease (IPD) patients with motor fluctuations and PD related chronic pain - Pain study Idiopathic Parkinson's Disease, Hoehn and Yahr stage between 2-3 inclusive during the ON” phase, experiencing motor fluctuations while on stable doses of L-Dopa (with or without benserazide/carbidopa, with or without addition of a catechol O-methyltransferase (COMT) inhibitor) and may be on stable doses of other PD medications (a dopamine agonist, an anticholinergic and/or amantadine), yet are experiencing more than 2 hours of OFF time per day and chronic PD related pain.
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xadago
Product Name: Xadago
INN or Proposed INN: Safinamide methansulfonate
Other descriptive name: SAFINAMIDE METHANESULFONATE
Trade Name: Xadago
Product Name: Xadago
INN or Proposed INN: Safinamide methansulfonate
Other descriptive name: SAFINAMIDE METHANESULFONATE
Zambon SpANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
177Phase 4Spain
250NCT04048291
(ClinicalTrials.gov)
October 15, 20189/10/2018Efficacy of Brisk Walking in Parkinson's DiseaseEfficacy of Brisk Walking on Improving Balance and Gait Performance, and Functional Mobility in Parkinson's Disease - a Randomized Controlled TrialParkinson DiseaseBehavioral: Brisk walking and balance training;Behavioral: Upper limb exerciseThe Hong Kong Polytechnic UniversityNULLCompleted30 YearsN/AAll80N/AHong Kong
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT04451096
(ClinicalTrials.gov)
October 6, 201819/6/2020Probiotics-prebiotic Fiber Therapy in Parkinson's Disease Patients With ConstipationProbiotics-prebiotic Fiber Therapy Improved Bowel Opening Frequency and Whole Gut Transit Time in Parkinson's Disease Patients With Constipation: A Randomised Controlled StudyParkinson Disease;ConstipationDietary Supplement: Probiotics with prebiotic;Dietary Supplement: PlaceboNational University of MalaysiaNULLCompleted18 YearsN/AAll48Phase 3Malaysia
252EUCTR2018-000346-19-FI
(EUCTR)
03/10/201809/07/2018An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
253EUCTR2016-004610-95-DE
(EUCTR)
01/10/201827/02/2018Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB054
INN or Proposed INN: n/a
Other descriptive name: BIIB054
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
254NCT03703570
(ClinicalTrials.gov)
September 29, 20185/10/2018A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing PreparationsA Phase 2b Study of KW-6356 in Subjects With Parkinson's Disease on Treatment With Levodopa-containing PreparationsParkinson's DiseaseDrug: KW-6356;Drug: PlaceboKyowa Kirin Co., Ltd.NULLCompleted20 Years80 YearsAll502Phase 2Japan
255NCT03648905
(ClinicalTrials.gov)
September 6, 201824/8/2018Clinical Laboratory Evaluation of Chronic Autonomic FailureClinical Laboratory Evaluation of Chronic Autonomic FailureParkinson's Disease;Multiple System Atrophy;Autonomic FailureDrug: 18F-Dopa;Drug: 11C-methylreboxetine;Drug: 13N-Ammonia;Drug: 18F-Dopamne;Drug: Desipramine (DMI)National Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll140Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256NCT03608371
(ClinicalTrials.gov)
August 31, 20189/5/2018BTRX-246040 Study in Subjects With Parkinson's Disease With Motor FluctuationsPhase 2A, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BTRX-246040 in Parkinson's Disease Subjects With Motor FluctuationsParkinson Disease;Motor DisorderDrug: BTRX-246040;Drug: PlaceboBlackThorn Therapeutics, Inc.NULLCompleted30 Years76 YearsAll24Phase 2United States
257EUCTR2016-004610-95-FR
(EUCTR)
08/08/201801/03/2018Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
311Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom;Sweden
258NCT03773796
(ClinicalTrials.gov)
August 6, 201819/7/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and EfficacyParkinson DiseaseDrug: Nabilone 0.25 mgMedical University InnsbruckNULLRecruiting30 Years100 YearsAll48Phase 3Austria
259JPRN-JMA-IIA00385
01/08/201812/09/2018Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's DiseaseKyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease Parkinson's diseaseIntervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value..Kyoto University HospitalNULLTemporarily Closed>=50 YEARS<70 YEARSBOTH7Phase 3Japan
260ChiCTR1800016949
2018-08-012018-07-04Efficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's diseaseEfficacy assessment and standard treatment of rasagiline in Chinese patients with early Parkinson's disease Parkinson's diseaseRasagiline early start group:rasagiline-rasagiline;Rasagiline delay start group:placebo-rasagiline;Beijing HospitalNULLPending3080BothRasagiline early start group:130;Rasagiline delay start group:130;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261ChiCTR1800017084
2018-08-012018-07-11Investigation of new approaches and technologies in the management of Parkinson's diseaseThe efficacy of Butylphthalide on cognitive impairment of patients with idiopathic PD and DBS patients: A Randomized, double-blind, placebo-controlled, multicenter trial Parkinson's diseaseButylphthalide group:Butylphthalide, 2 capsules/time, 3 times/day, for 48 weeks;Control group:Placebo, 2 capsules/time, 3 times/day, for 48 weeks;Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNULLRecruiting1880BothButylphthalide group:140;Control group:140;Phase 4China
262NCT04455555
(ClinicalTrials.gov)
August 1, 201828/6/2020Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseEfficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseParkinson's DiseaseDrug: LY03003( the name of rotigotine);Other: PlaceboPeking University Third HospitalNULLCompleted18 YearsN/AAll294Phase 3China
263EUCTR2017-005170-19-SE
(EUCTR)
30/07/201810/04/2018A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension StudyA Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Renishaw Neuro Solutions Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
264NCT03611569
(ClinicalTrials.gov)
July 25, 201826/7/2018Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseInterventional, Randomized, Double-blind, Sequential-group, Placebo-controlled, Single-ascending-dose Study Investigating the Safety, Tolerability and Pharmacokinetic and Pharmacodynamic Properties of Lu AF82422 in Healthy Non-Japanese and Japanese Subjects and in Patients With Parkinson's DiseaseHealthy;Parkinson DiseaseDrug: Lu AF82422;Drug: PlaceboH. Lundbeck A/SNULLRecruiting18 Years80 YearsAll84Phase 1United States
265NCT03587168
(ClinicalTrials.gov)
July 20, 20183/7/2018The Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's DiseaseThe Reliability, Validity, and Responsiveness of the Timed 360° Turn Test in Patients With Parkinson's DiseaseParkinson DiseaseOther: the timed 360° turn test;Other: Berg Balance Scale;Other: Four Square Step Test;Other: Functional Reach Test;Other: Trunk Impairment Scale;Other: Timed Up and Go Test;Other: Hoehn and Yahr Scale;Other: Unified Parkinson's Disease Rating ScaleGazi UniversityNULLCompleted40 YearsN/AAll86Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266JPRN-jRCTs052180158
19/07/201825/03/2019The effect of rehabilitation robots for patients with Parkinson's disease.A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. Parkinson's Disease;D010300Robot group: The participants performs twelve per a session, 2sessions per a week for 8 weeks.
Control group: The participants receives balance exercise by physical therapist twice a week for 8 weeks.
Domen KazuhisaNULLRecruiting>= 40age old<= 80age oldBoth50N/AJapan
267NCT03594656
(ClinicalTrials.gov)
July 15, 201811/7/2018Effects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's DiseaseEffects of Lingzhi on Disease Progression in Patients With Untreated Early Parkinson's Disease: A Multicenter, Randomized, Double-blind, Placebo-controlled TrialParkinson DiseaseDrug: Ganoderma;Drug: PlacebosXuanwu Hospital, BeijingNULLRecruiting30 Years80 YearsAll288Phase 3China
268NCT03624920
(ClinicalTrials.gov)
July 12, 201810/7/2018Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessSafety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessParkinson DiseaseDrug: THN102 Dosage A;Drug: THN102 Dosage B;Drug: THN102 Dosage CTheranexusNULLCompleted18 Years80 YearsAll77Phase 2United States;Czechia;France;Germany;Hungary
269NCT03146130
(ClinicalTrials.gov)
July 5, 20183/5/2017Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control DisordersStudy of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders (TCI) Induced by Dopaminergic Treatments in Parkinson's DiseaseImpulse Control Disorder;ParkinsonBiological: Variation of behaviors of Parkinson's diseaseCentre Hospitalier Universitaire, AmiensNULLUnknown status18 YearsN/AAll70Phase 3France
270EUCTR2017-004335-36-ES
(EUCTR)
04/07/201811/04/2018A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients.A Phase II, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Parkinson’s Disease with Dementia Patients. - A Phase II Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 Cognition in Parkinson’s Disease with dementia;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: ANAVEX2-73
INN or Proposed INN: ANAVEX2-73
Product Name: ANAVEX2-73
INN or Proposed INN: ANAVEX2-73
Anavex Life Sciences Corp.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT03521635
(ClinicalTrials.gov)
July 3, 201811/4/2018The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-DopaA Two- Stage Multicenter, Open-label, Randomized, Active Controlled Parallel Group Study Comparing the Efficacy and Safety of Pramipexole SR Versus Pramipexole IR Administered Orally Over an 18-week Treatment on Nocturnal Symptoms in L-Dopa+ Treated Patients With Advanced Parkinson's Disease (PD)Parkinson DiseaseDrug: Pramipexole SR;Drug: Pramipexole IRBoehringer IngelheimNULLCompleted30 YearsN/AAll98Phase 4China
272JPRN-UMIN000033409
2018/07/0217/07/2018Prevention of local skin reaction by heparinoid due to rotigotine transdermal patch: a pilot randomized clinical trial. Parkinson's diseasePretreatment by heparinoid
In the pretreatment group, heparinoid is applied daily to the sites (shoulder, upper arm, abdomen, thigh, buttocks on both sides) to be applied rotigotine transdermal patch from the beginning of 1 week before. The dose is one finger tip unit (about 0.5 g) for two palms. The period is 8 weeks.
Non-pretreatment by heparinoid.
The non-pretreatment group use rotigotine without using heparinoid. The period is 8 weeks.
Wakayama Medical UniversityNULLRecruiting20years-old85years-oldMale and Female20Phase 1Japan
273NCT03566589
(ClinicalTrials.gov)
July 2, 201812/6/2018Effects of PS128 on Parkinsonian SymptomsEffects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot StudyParkinson DiseaseDietary Supplement: Lactobacillus plantarum PS128Professor Lu Neurological ClinicNULLCompleted40 Years80 YearsAll30N/ATaiwan
274JPRN-UMIN000033454
2018/07/0120/07/2018A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. - A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient. Parkinson's Diseaserobot assisted balance training (RABT)
The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16.
traditional balance training (TBT)
The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16.
Hyogo College of MedicineNULLRecruiting40years-old80years-oldMale and Female50Not selectedJapan
275NCT03576638
(ClinicalTrials.gov)
July 201825/6/2018Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease PatientsAn Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release TabletIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll12Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT03407378
(ClinicalTrials.gov)
June 26, 201815/1/2018A Study to Investigate a New Treatment in Patients With Parkinson's DiseaseA Proof of Concept Study to Investigate the Effect of IPT803 Adjunct Treatment in Patients With Parkinson's DiseaseParkinson DiseaseDrug: IPT803;Genetic: Optional pharmacogenetic assessment;Other: Questionnaires;Other: Optional Blood-Oxygen-level Dependent functionalMRI;Other: Motor Assessments before taking regular PD treatment;Other: Motor Assessments on regular PD treatmentTools4PatientNULLCompleted35 YearsN/AAll110Phase 1;Phase 2United States;Belgium;France
277EUCTR2017-001420-21-DE
(EUCTR)
18/06/201816/02/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
278EUCTR2017-001420-21-ES
(EUCTR)
13/06/201815/03/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
279EUCTR2017-004006-18-NL
(EUCTR)
07/06/201815/11/2017The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's diseaseTherapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia.
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Levodopa powder for inhalation
Product Code: Levodopa Cyclops
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Trade Name: Madopar 125 mg, orodispersible tablet
Pharmaceutical Technology and Biopharmacy, University of GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8Phase 2Netherlands
280EUCTR2018-000346-19-SE
(EUCTR)
04/06/201809/04/2018An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT03684122
(ClinicalTrials.gov)
June 1, 201823/9/2018Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).A Safety and Efficacy Study of the Effects of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) on the Motor and Non-motor Symptoms in People With Parkinson's Disease (PD).Parkinson DiseaseBiological: Injection of Umbilical cord derived MSCsUniversity of JordanNULLRecruiting20 Years75 YearsAll10Phase 1;Phase 2Jordan
282EUCTR2017-002780-17-ES
(EUCTR)
21/05/201812/02/2018Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa.A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension Parkinson’s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ND0612
Product Code: ND0612
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET Plus
Product Name: SINEMET
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: Duodopa LD/CD 20/5 mg/mL
Product Name: Duodopa LD/CD 20/5 mg/mL
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;United States;Spain;Austria;Netherlands;Italy
283EUCTR2016-004610-95-ES
(EUCTR)
18/05/201807/03/2018Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB054
INN or Proposed INN: n/a
Other descriptive name: BIIB054
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
311Phase 2France;United States;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom;Sweden
284NCT03589066
(ClinicalTrials.gov)
May 15, 20188/6/2018Pharmacokinetic Study of LY03003 in Patients With Parkinson's DiseaseAn Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's DiseaseParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLCompleted18 YearsN/AAll24Phase 1United States
285EUCTR2017-004475-31-CZ
(EUCTR)
09/05/201809/05/2018Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease. Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease Excessive daytime sleepiness associated with Parkinson’s disease
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Theranexus S.A.NULLNot Recruiting Female: yes
Male: yes
60Phase 2France;United States;Hungary;Czech Republic;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT03541356
(ClinicalTrials.gov)
May 8, 20185/4/2018Therapeutic Potential for Intranasal Levodopa in Parkinson's Disease -Off ReversalA Phase IIa, Randomized, Double Blind, Placebo Controlled, Single Ascending Dose, Safety and Pharmacokinetic/Pharmacodynamic Study of INP103 (POD L-dopa) Administered in the Presence of DCI to L-dopa Responsive Parkinson's Disease PatientsParkinson's DiseaseCombination Product: Placebo;Combination Product: L-dopa 35 mg;Combination Product: L-dopa 70mg;Combination Product: L-dopa 140 mg;Combination Product: L-dopa 70mg/carbidopa 7mgImpel NeuroPharma Inc.NULLCompleted40 Years80 YearsAll32Phase 2Australia
287NCT03587649
(ClinicalTrials.gov)
May 7, 20183/7/2018Evaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density LossEvaluation of [18F]MNI-1126 as an Imaging Marker for Synaptic Density Loss in the Brain of Patients With Probable Alzheimer's Disease, Probable Parkinson's Disease (PD) Subjects as Compared to Healthy Volunteers (HV).Alzheimer Disease;Parkinson Disease;Healthy VolunteersDrug: [18F]MNI-1126InvicroNULLCompleted18 Years55 YearsAll12Phase 1United States
288NCT04228887
(ClinicalTrials.gov)
May 4, 20185/8/2019Effects of Inspiratory Muscle Training in Patients With Parkinson's DiseaseEffects of Inspiratory Muscle Training on Postural Stability, Mobility, Activities of Daily Living, Quality of Life and Respiratory Function in Patients With Parkinson's DiseaseParkinson DiseaseDiagnostic Test: Respiratory Muscle Strength;Device: Balance Training;Device: Inspiratory Muscle TrainingBezmialem Vakif UniversityNULLCompleted60 Years85 YearsAll30N/ATurkey
289EUCTR2016-004610-95-GB
(EUCTR)
01/05/201827/12/2017Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB054
INN or Proposed INN: n/a
Other descriptive name: BIIB054
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;Italy;United Kingdom
290NCT03843944
(ClinicalTrials.gov)
May 1, 201812/2/2019Overnight Switch From Rasagiline To SafinamideOvernight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety StudyParkinson DiseaseDrug: SafinamideIRCCS San RaffaeleNULLCompleted30 Years80 YearsAll20Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2017-002780-17-FR
(EUCTR)
26/04/201827/02/2018-A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension Parkinson’s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
292NCT03230526
(ClinicalTrials.gov)
April 20, 201818/7/2017Identification of a Biomarker Predictive of Evolution of Parkinson DiseaseBrain Microglial Activation in the Early Stage of the Parkinson's Disease: a Predictive Biomarker of the Evolution?Parkinson DiseaseDrug: [18F]DPA-714 PET scanNantes University HospitalNULLRecruiting40 Years67 YearsAll64Phase 2France
293NCT03374917
(ClinicalTrials.gov)
April 18, 20188/12/2017A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient EnvironmentAn Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient EnvironmentParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted30 Years85 YearsAll20Phase 1United States
294EUCTR2017-004475-31-HU
(EUCTR)
17/04/201809/02/2018Safety and efficacy study of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease.Randomised, double-blind, placebo-controlled, complete 3-way cross-over phase IIa trial to investigate safety and efficacy of two THN102 doses in subjects with excessive daytime sleepiness associated with Parkinson’s disease Excessive daytime sleepiness associated with Parkinson’s disease
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10041349;Term: Somnolence;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Flecainide acetate
Product Code: THN02
INN or Proposed INN: Flecainidum
Other descriptive name: FLECAINIDE ACETATE
Product Name: Flecainide acetate
Product Code: THN02
INN or Proposed INN: Flecainidum
Other descriptive name: FLECAINIDE ACETATE
Trade Name: Modiodal
Product Name: over-encapsulated Modafinil
INN or Proposed INN: MODAFINIL
Theranexus S.A.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Czech Republic;Hungary;Germany
295EUCTR2017-004253-16-AT
(EUCTR)
13/04/201827/02/2018Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-Motor symptoms (e.g.sleeping dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...)Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy Subject with non-Motor symptoms of Parkinson´s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Medizinische Universität Innsbruck, Universitätsklinik für NeurologieNULLNot Recruiting Female: yes
Male: yes
48Phase 3Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2017-002780-17-IT
(EUCTR)
10/04/201804/11/2020study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusionA Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered Parkinson¿s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET Plus
Product Name: SINEMET
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Trade Name: Duodopa LD/CD 20/5 mg/mL
Product Name: Duodopa LD/CD 20/5 mg/mL
INN or Proposed INN: LEVODOPA
Other descriptive name: levodopa
INN or Proposed INN: CARBIDOPA
Other descriptive name: carbidopa
Product Name: ND0612
Product Code: ND0612
INN or Proposed INN: CARBIDOPA
Other descriptive name: carbidopa
INN or Proposed INN: LEVODOPA
Other descriptive name: levodopa
NEURODERM LTD.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
297EUCTR2017-002707-10-DK
(EUCTR)
10/04/201803/11/2017Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effectsSerum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies
MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10075174;Term: Mixed dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Memantin Orion
INN or Proposed INN: MEMANTINE
Product Name: Donepezil Sandoz
Product Code: 25330
INN or Proposed INN: DONEPEZIL
Regional Dementia Research Centre, Dept of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 4Denmark
298EUCTR2016-003456-70-DE
(EUCTR)
04/04/201803/04/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomor
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
299ChiCTR1800015331
2018-04-012018-03-23Dopaminergic Mechanisms of Temporal Working Memory in Parkinson's DiseaseDopaminergic Mechanisms of Temporal Working Memory in Parkinson's Disease Parkinson's diseasede novo PD patients:levodopa 4 weeks;de novo PD patients:pramipexole 4 weeks;de novo PD patients:selegiline 4 weeks;Institute of Psychology, Chinese Academy of SciencesNULLRecruiting5080Bothde novo PD patients:50;de novo PD patients:50;de novo PD patients:50;China
300EUCTR2017-004297-34-GB
(EUCTR)
31/03/201822/06/2018Use of low-dose zolpidem in Parkinson's.A placebo controlled double blind randomised controlled proof of concept study of zolpidem for the treatment of motor and cognitive deficits in late-stage Parkinson’s - Zolpidem for treatment of motor and cognitive deficits in Parkinson's Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Stilnoct
Product Name: Stilnoct
Product Code: 207-3120
INN or Proposed INN: Zolpidem Tartrate
Aston UniversityNULLNot RecruitingFemale: yes
Male: yes
28Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2018-000405-23-FI
(EUCTR)
27/03/201821/02/2018Postitron emission tomography imaging of neuroinflammation in Parkinson´s diseaseIn vivo PET imaging of neuroinflammation in Parkinson’s disease using the purinergic P2X7 receptor ligand [11C]SMW139 (PRI-PD) - PRI-PD Parkinson´s disease
MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: (2-chloro-5-[11C]methoxy-N-(((3s,5s,7s)-3,5,7-trifluoroadamantan-1-yl)methyl) benzamide)
Product Code: [11C]SMW139
Juha Rinne / PET CentreNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
14Phase 2Finland
302EUCTR2016-004610-95-AT
(EUCTR)
23/03/201804/01/2018Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants with Parkinson’s DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, with an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects with Parkinson’s Disease - SPARK Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: BIIB054
INN or Proposed INN: n/a
Other descriptive name: BIIB054
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
357Phase 2United States;France;Canada;Spain;Austria;Israel;Germany;United Kingdom;Italy
303NCT03457493
(ClinicalTrials.gov)
March 22, 201823/2/2018TSPO-PET for Neuroinflammation in Parkinson's DiseaseUAB Neuroinflammation in Parkinson's Disease - TSPO-PET SubstudyParkinson DiseaseDrug: DPA-714-PET/MRIUniversity of Alabama at BirminghamNULLRecruiting30 YearsN/AAll20Phase 1;Phase 2United States
304NCT03301272
(ClinicalTrials.gov)
March 22, 201813/9/2017Effectiveness of Botox on Reducing Rest Tremor in Parkinson's DiseaseEffectiveness of Onabotulinumtoxin A on Reduction of Rest Tremor in Parkinson's Disease: a Pilot StudyParkinson DiseaseDrug: Onabotulinumtoxin A Injection;Other: PlaceboUniversity of North Carolina, Chapel HillNULLCompleted45 Years80 YearsAll16Phase 2United States
305NCT03482882
(ClinicalTrials.gov)
March 9, 201823/3/2018Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and DepressionAn Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and DepressionTreatment of Depression in Adults With Parkinson's Disease (PD)Drug: PimavanserinACADIA Pharmaceuticals Inc.NULLCompleted50 YearsN/AAll47Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT03149809
(ClinicalTrials.gov)
March 1, 20189/5/2017Behavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson DiseaseBehavioral or Solifenacin Therapy for Urinary Symptoms in Parkinson DiseaseOveractive Bladder;Parkinson DiseaseDrug: solifenacin;Behavioral: Pelvic floor muscle exercise-based behavioral therapyVA Office of Research and DevelopmentNULLRecruitingN/AN/AAll90Phase 3United States
307NCT04265027
(ClinicalTrials.gov)
February 20, 20187/2/2020Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers.Parkinson DiseaseDrug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg OngentysBial - Portela C S.A.NULLCompleted18 Years55 YearsAll72Phase 1United Kingdom
308NCT03882398
(ClinicalTrials.gov)
February 15, 201811/3/2019Effects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's DiseaseEffects of a High-intensity Progressive-cycle Program on Quality of Life and Motor Symptomatology in Parkinson's Disease Population: a Pilot Randomized Controlled TrialParkinson Disease;Exercise;Physical Activity;Quality of LifeOther: Balance;Other: EnduranceUniversity of VigoNULLCompleted60 Years80 YearsAll14N/ASpain
309NCT03496870
(ClinicalTrials.gov)
February 8, 20181/3/2018A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Carbidopa LevodopaNeurocrine BiosciencesNULLCompleted18 Years85 YearsAll16Phase 1United States
310EUCTR2016-000637-43-ES
(EUCTR)
06/02/201807/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT03189563
(ClinicalTrials.gov)
February 6, 201812/6/2017Safety and Efficacy of DA-9805 for Parkinson's DiseaseA Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of DA-9805 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: DA-9805 45mg;Drug: DA-9805 90mg;Other: PlaceboDong-A ST Co., Ltd.NULLCompleted30 Years79 YearsAll60Phase 2United States
312EUCTR2016-003456-70-ES
(EUCTR)
06/02/201807/12/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
85Phase 3Spain;Austria;United Kingdom
313EUCTR2016-000637-43-AT
(EUCTR)
01/02/201815/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;United Kingdom;Italy
314NCT03329508
(ClinicalTrials.gov)
January 29, 201830/10/2017A Phase 3 Study With P2B001 in Subjects With Early Parkinson'sA Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.Parkinson DiseaseDrug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ERPharma Two B Ltd.NULLRecruiting35 Years80 YearsAll525Phase 3United States;Canada;Germany;Spain
315JPRN-UMIN000030930
2018/01/2901/01/2019Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease.Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. - Effect of febuxostat and inosine on Parkinson's disease Parkinson's diseaseAdministration of febuxostat 20 mg and inosine 500 mg twice a day for 58 daysStaGen Co. Ltd.NULLComplete: follow-up complete20years-old80years-oldMale and Female30Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2016-001403-23-HU
(EUCTR)
23/01/201822/01/201812-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
317ChiCTR1800014542
2018-01-222018-01-20Up-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's diseaseUp-down sequential testing of propofol - induced half-effective dose ( ed50 ) in patients with Parkinson's disease and non - Parkinson's disease Parkinson's DiseasePD group:propofol;NPD group:propofol;Xuanwu Hospital of CCMUNULLRecruiting1865BothPD group:40;NPD group:40;China
318NCT03531086
(ClinicalTrials.gov)
January 19, 20188/5/2018Idiopathic Parkinson's Progression and Dopamine Transporter SPECTExploring Dopamine Transporter Single-photon Emission Computer Tomography Quantification as a Measure of Disease Progression in Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: Ioflupane I 123Julie GurwellNULLActive, not recruiting40 Years75 YearsAll12United States
319NCT03331848
(ClinicalTrials.gov)
January 15, 20181/11/2017Study to Evaluate the Efficacy, Safety, and Tolerability of PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety, and Tolerability of 8-week Oral Treatment With PXT002331 (Foliglurax) in Reducing Levodopa-Induced Dyskinesia and Wearing OFF in Subjects With Parkinson's Disease Experiencing Motor Complications of Levodopa Therapy (ATTUNED)Parkinson DiseaseDrug: Placebo oral capsule;Drug: PXT002331 - 20mgPrexton TherapeuticsNULLWithdrawn35 Years85 YearsAll0Phase 2NULL
320NCT03318523
(ClinicalTrials.gov)
January 10, 201819/10/2017Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Participants With Parkinson's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study, With an Active-Treatment Dose-Blinded Period, to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BIIB054 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: BIIB054BiogenNULLActive, not recruiting40 Years80 YearsAll357Phase 2United States;Austria;Canada;France;Germany;Israel;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321NCT03550183
(ClinicalTrials.gov)
January 10, 201811/5/2018Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's DiseaseSafety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsParkinson's DiseaseBiological: mesenchymal stem cellsHebei Newtherapy BIo-Pharma technology Co., Ltd.NULLEnrolling by invitation40 Years80 YearsAll20Phase 1China
322EUCTR2016-003456-70-AT
(EUCTR)
04/01/201816/11/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;Italy;United Kingdom
323EUCTR2017-000087-15-DE
(EUCTR)
21/12/201717/05/2017A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6 -Year all-Participants-on Treatment Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
324EUCTR2017-003458-18-GB
(EUCTR)
19/12/201727/09/2017A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaA randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia Parkinson's disease dyskinesia
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Integrative Research Laboratories AB (IRLAB)NULLNot Recruiting Female: yes
Male: yes
74Phase 2United Kingdom;Sweden
325EUCTR2017-000877-35-IT
(EUCTR)
04/12/201710/11/2020A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson's Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson's Disease Patients (CASPAR) Excessive daytime sleepiness with Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Bavisant
Product Code: JNJ31-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Product Name: Bavisant
Product Code: [JNJ31-31001074]
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
BENEVOLENTAI BIONULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czechia;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326JPRN-UMIN000030084
2017/12/0101/12/2017Practical evaluation of PET studies with [18F]-GE180, [18F]-FDOPA and [18F]-FLT for a future clinical trial of iPSC-based cell therapy in Parkinson's disease neuroinflammatory disorder, Parkinson's disease, Brain tumor[18F]GE180 is injected intravenously as 3-4 MBq/Kg. PET is dynamically scanned for 90 minutes.

Carbidopa 150mg is administrated orally 1hr before scan.[18F]FDOPA is injected intravenously as 3-4 MBq/Kg. Dynamic PET is scanned for 90 minutes.

[18F]FLT is injected intravenously as 3-4 MBq/Kg. Statical PET is scanned after 60 minutes
Kyoto UniversityNULLComplete: follow-up complete50years-oldNot applicableMale and Female12Phase 1;Phase 2Japan
327NCT03377322
(ClinicalTrials.gov)
December 1, 20177/12/2017Trial of Probiotics for Constipation in Parkinson's DiseaseA Randomized Double-Blinded Placebo-Controlled Trial of Probiotics for Constipation in Parkinson's DiseaseParkinson DiseaseDrug: Probiotic Capsule;Drug: Placebo CapsuleUniversity of MalayaNULLCompleted40 Years85 YearsAll72N/AMalaysia
328NCT03944785
(ClinicalTrials.gov)
November 30, 20171/5/2019Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)TabletsIdiopathic Parkinson DiseaseDrug: XADAGO (safinamide)US WorldMeds LLCNULLCompleted30 Years80 YearsAll209United States
329EUCTR2016-002033-30-GB
(EUCTR)
27/11/201705/09/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
330NCT03194217
(ClinicalTrials.gov)
November 10, 201719/6/2017BEN-2001 in Parkinson Disease Patients With Excessive Daytime SleepinessDose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).Excessive Daytime Sleepiness;Parkinson DiseaseDrug: BEN-2001;Drug: PlaceboBenevolentAI BioNULLCompleted50 Years80 YearsAll244Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT03305809
(ClinicalTrials.gov)
November 9, 20174/10/2017A Study of LY3154207 in Participants With Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)Effect of LY3154207 on Cognition in Mild-to-Moderate Dementia Due to Lewy Body Dementia (LBD) Associated With Idiopathic Parkinson's Disease (PD) or Dementia With Lewy Bodies (DLB)Lewy Body DementiaDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted40 Years85 YearsAll344Phase 2United States;Canada;Puerto Rico;China
332EUCTR2016-002033-30-HU
(EUCTR)
08/11/201719/09/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Netherlands;Germany
333NCT02611167
(ClinicalTrials.gov)
November 1, 201711/11/2015Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's DiseasePilot Phase I Study of Allogeneic Bone Marrow-Derived Mesenchymal Stem Cell Therapy for Idiopathic Parkinson's DiseaseParkinson's DiseaseBiological: Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg);Biological: Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg)The University of Texas Health Science Center, HoustonNULLCompleted45 Years70 YearsAll20Phase 1United States
334NCT03232996
(ClinicalTrials.gov)
November 1, 201724/7/2017Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.Evaluation of a Computer Game Based Rehabilitation System for Assessment and Treatment of Balance and Gait Impairments in Individuals With Parkinson's Disease.Parkinson Disease;ParkinsonOther: Computer game based balance and walking rehabilitation for individuals with Parkinson's DiseaseUniversity of ManitobaNULLCompleted55 Years70 YearsAll30N/ACanada
335EUCTR2017-000877-35-DE
(EUCTR)
19/10/201704/09/2017A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.Dose finding phase IIb study of Bavisant to evaluate its safety and effiCacy in treAtment of exceSsive daytime sleePiness (EDS) in PARkinson’s Disease (PD). CASPAR study. - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) Excessive daytime sleepiness with Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
BenevolentAI BioNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czech Republic;Spain;Poland;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT03250117
(ClinicalTrials.gov)
October 10, 201711/8/2017Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral RopiniroleAn Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-DopaParkinson DiseaseDrug: Ropinirole oral product;Drug: Ropinirole ImplantTitan PharmaceuticalsNULLTerminated30 Years80 YearsAll3Phase 1;Phase 2United States
337NCT03769896
(ClinicalTrials.gov)
October 3, 20176/12/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: A Randomized Placebo-controlled, Double-blind, Parallel-group, Enriched Enrolment Randomized Withdrawal StudyParkinson DiseaseDrug: Nabilone 0.25 mg;Drug: PlaceboMedical University InnsbruckNULLCompleted30 Years100 YearsAll48Phase 2Austria
338EUCTR2017-001673-17-FI
(EUCTR)
03/10/201729/08/2017A study to evaluate the safety and tolerability of IRL752 treatment inpatients with Parkinson's disease dementia.A randomized, double-blind, placebo-controlled, multi-centre phase IIastudy evaluating the safety and tolerability of IRL752 in patients withParkinson's Disease Dementia Dementia in Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;System Organ Class: 100000014717;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IRL752
INN or Proposed INN: IRL752
Integrative Research Laboratories ABNULLNot RecruitingFemale: yes
Male: yes
40Phase 2Finland;Sweden
339ChiCTR1800019216
2017-09-302018-10-31Study for accurate diagnosis and treatment of Parkinson's disease by using the combination of TMS-EEGStudy for accurate diagnosis and treatment of Parkinson's disease by using the combination of TMS-EEG Parkinson's diseaseBradykinesia Group:Sick side, SAM region, 10Hz rTMS;Tremor Group:Sick side, M1 region, 1Hz rTMS;Health control:N/A;Shenzhen People's HospitalNULLRecruiting5080BothBradykinesia Group:30;Tremor Group:30;Health control:30;China
340NCT03257046
(ClinicalTrials.gov)
September 28, 201714/8/2017Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ITI-214 in Parkinson's DiseaseA Randomized, Placebo-Controlled, Double-Blind Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of ITI-214 in Patients With Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: ITI-214;Other: PlaceboIntra-Cellular Therapies, Inc.NULLCompleted50 YearsN/AAll40Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2015-004175-73-FI
(EUCTR)
27/09/201707/07/2016A clinical study to test the safety of CDNF by brain infusion in patients with Parkinson's disease.A Phase I-II, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intermittent Bilateral Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Administered via an Investigational Drug Delivery System to Patients with Idiopathic Parkinson’s Disease (PD) of Moderate Severity. Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
17Phase 1;Phase 2Finland
342NCT03104725
(ClinicalTrials.gov)
September 25, 20174/4/2017Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?Does N-Acetylcysteine Decrease Spontaneous Oxidation of Central Neural Dopamine in Parkinson's Disease?Parkinson Disease;Cerebrospinal FluidDrug: N-Acetylcysteine;Procedure: Lumbar Puncture;Radiation: FluoroscopyNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted18 YearsN/AAll6Phase 1United States
343EUCTR2017-000128-81-DE
(EUCTR)
20/09/201706/07/2017PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEPHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE Parkinson’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PF-06649751 - 1mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 5mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 15mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Canada;Spain;Germany
344EUCTR2017-000192-86-AT
(EUCTR)
15/09/201710/08/2017Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-motor symptoms (e.g.sleeping disorders,cognitive dysfunction, hallucinations, autonomic dysfunction including urinary incontinence, constipation,...)Nabilone for non-motor symptoms in Parkinson´s disease: A Randomized Placebo-controlled, double-blind, parallel-group, enriched enrollment randomized withdrawal Study Subjects with non-motor symptoms of Parkinson´s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Medizinische Universität Innsbruck, Universitätsklinik für NeurologieNULLNot Recruiting Female: yes
Male: yes
48Phase 2Austria
345NCT03306329
(ClinicalTrials.gov)
September 13, 201725/9/2017DNS-7801 vs. Placebo in Parkinson's DiseaseA Phase 2a, Double-Blind, Placebo-Controlled Two-Part Study To Investigate the Safety and Efficacy of Increasing Doses Of DNS-7801 In Parkinson's Disease (PD) Subjects With Motor FluctuationsParkinson's DiseaseDrug: DNS-7801 (low-dose);Drug: DNS-7801 (high dose);Drug: PlaceboDart NeuroScience, LLCNULLTerminated30 YearsN/AAll5Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346EUCTR2016-003961-25-CZ
(EUCTR)
07/09/201715/05/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;United Kingdom
347NCT03272230
(ClinicalTrials.gov)
September 6, 20173/8/2017Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based SystemAssessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral DiseaseApathy;Frontotemporal Dementia;Parkinson Disease;Depressive SymptomsBehavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's DiseaseInstitut National de la Santé Et de la Recherche Médicale, FranceNULLRecruiting40 Years85 YearsAll135N/AFrance
348JPRN-jRCTs041180018
04/09/201720/12/2018Pupillary autonomic dysfunction and visual hallucination in Parkinson's diseaseAssociation between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease - Pupillary autonomic dysfunction and visual hallucination in Parkinson's disease Parkinson's disease and related diseasesTwo drops of 0.05% pilocarpine hydrochloride, which is a parasympathomimetic agent, on the right eye, 2 drops of 0.04% dipivefrin hydrochloride, which is a sympathomimetic agent, to the left eyekatsuno MasahisaNULLRecruiting>= 40age oldNot applicableBoth40Phase 2Japan
349ChiCTR-INR-17012013
2017-09-012017-07-17Clinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's diseaseClinical study of botulinum toxin type A in the treatment of depressive symptoms in patients with Parkinson's disease Parkinson‘s disease, DepressionBTX-A:BOTOX Allergan;Placebo:0.9% Sodium Chloride Injection;Shanghai Tongji Hospital, Tongji UniversityNULLPending1880BothBTX-A:40;Placebo:40;China
350EUCTR2017-000128-81-ES
(EUCTR)
28/08/201712/07/2017PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEPHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE Parkinson’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PF-06649751 - 1mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 5mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 15mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Canada;Spain;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT03292016
(ClinicalTrials.gov)
August 22, 201711/9/2017A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by OFF EpisodesA Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277;Drug: APO-go;Drug: ApokynSunovionNULLCompleted18 YearsN/AAll8Phase 2United States
352EUCTR2017-000087-15-AT
(EUCTR)
17/08/201718/05/2017A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab(PRX002) in Participants with Early Parkinson's Disease with A 6-Year all-Participants-on-Treatment Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
353NCT04162275
(ClinicalTrials.gov)
August 15, 201722/9/2019A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in ChinaA Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalation Tolerance and Pharmacokinetics Study of Oral Taking Finamine Tablets in Chinese Healthy-adult SubjectsParkinson DiseaseDrug: Finamine tablets;Drug: Placebo tabletsYiling Pharmaceutical Inc.NULLActive, not recruiting18 Years65 YearsAll34Phase 1China
354NCT03204929
(ClinicalTrials.gov)
August 14, 201728/6/2017Dose Escalation Study of Cu(II)ATSM in Parkinson's DiseaseA Phase 1 Dose Escalation Study of Cu(II)ATSM Administered Orally to Patients With Early Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: Cu(II)ATSMCollaborative Medicinal Development Pty LimitedNULLCompleted30 YearsN/AAll31Phase 1Australia
355EUCTR2017-000877-35-CZ
(EUCTR)
09/08/201705/06/2017A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) Excessive daytime sleepiness with Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
BenevolentAI BioNULLNot Recruiting Female: yes
Male: yes
240Phase 2United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356EUCTR2017-000877-35-GB
(EUCTR)
08/08/201717/07/2017A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) Excessive daytime sleepiness with Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
BenevolentAI BioNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom
357EUCTR2017-000877-35-ES
(EUCTR)
03/08/201709/06/2017A phase IIb, randomized, double blind, parallel group, placebo control, multicentre, 6-week dose-finding study to assess the efficacy and safety of Bavisant for the treatment of excessive daytime sleepiness in subjects with Parkinson's disease.Dose finding phase IIb study of Bavisant to evaluate its safety and efficacy in treatment of excessive daytime sleepiness (EDS) in parkinson’s Disease (PD). - Treatment of excessive daytime sleepiness with Bavisant in Parkinson’s Disease Patients (CASPAR) Excessive daytime sleepiness with Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
Product Name: Bavisant
Product Code: JNJ-31001074
INN or Proposed INN: Bavisant dihydrochloride monohydrate
Other descriptive name: BAVISANT HYDROCHLORIDE MONOHYDRATE
BenevolentAI BioNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United Kingdom;United States;Czech Republic;Poland;Spain;Germany;Italy
358NCT03187301
(ClinicalTrials.gov)
August 3, 20177/6/2017A Cardiac Safety Study of an Investigational Drug to See How if Affects the Heart in People With Parkinson's Disease Complicated by Motor Fluctuations OFF EpisodesA Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson's Disease;Off Episodes of Parkinson DiseaseDrug: APL-130277;Drug: Placebo;Drug: MoxifloxacinSunovionNULLCompleted18 YearsN/AAll48Phase 2United States;Italy
359EUCTR2014-004865-26-GR
(EUCTR)
01/08/201725/04/201726-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 3United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden
360ChiCTR-IPR-17011875
2017-08-012017-07-05Effects of Baduanjin Combined Balance Training on Gait and Posture Control of Patients with Mild and Moderate Parkinson's DiseaseEffects of Baduanjin Combined Balance Training on Gait and Posture Control of Patients with Mild and Moderate Parkinson's Disease Parkinson's DiseaseControl group:Conventional drug therapy;Baduanjin group:Baduanjin aerobic exercise;Balance function training group:Balance function training group;Affiliated Lianyungang Hospital of Xuzhou Medical UniversityNULLPending4080BothControl group:30;Baduanjin group:30;Balance function training group:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2017-000087-15-FR
(EUCTR)
27/07/201730/10/2017A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
362EUCTR2017-000087-15-ES
(EUCTR)
26/07/201708/06/2017A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
363NCT03178786
(ClinicalTrials.gov)
July 18, 20175/6/2017Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's DiseaseVisual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's DiseaseParkinson DiseaseBehavioral: PAT sessionsNYU Langone HealthNULLRecruiting40 Years75 YearsAll40N/AUnited States
364NCT03412513
(ClinicalTrials.gov)
July 17, 201721/1/2018Mirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's DiseaseMirabegron for Treatment of Overactive Bladder Symptoms in Patients With Parkinson's Disease: a Double-blind, Randomized Placebo-controlled TrialOveractive Bladder;Parkinson DiseaseDrug: Mirabegron;Drug: PlaceboSeoul National University HospitalNULLUnknown status40 Years80 YearsAll144Phase 4Korea, Republic of
365NCT03555292
(ClinicalTrials.gov)
July 12, 201724/4/201811C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesSafety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesParkinson DiseaseDrug: 11C-PiBOriental Neurosurgery Evidence-Based-Study TeamNULLRecruiting18 YearsN/AAll200Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366ChiCTR-IPR-17011987
2017-07-122017-07-14The effect of conduction exercise and self-acupressure in treatment of Parkinson’s disease: a pilot studyThe effect of conduction exercise and self-acupressure in treatment of Parkinson’s disease: a pilot study Parkinson's DiseaseGroup 1:CE+ SA + routine western medications;Group 2:Routine western medications only (control);HKBU School of Chinese MedicineNULLRecruiting1880BothGroup 1:29;Group 2:29;China
367EUCTR2017-000135-14-ES
(EUCTR)
07/07/201709/06/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany
368EUCTR2015-005814-31-BE
(EUCTR)
06/07/201705/05/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
369NCT03185481
(ClinicalTrials.gov)
July 6, 20179/6/2017Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson's Disease With Motor FluctuationsDrug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QDPfizerNULLTerminated40 Years87 YearsAll5Phase 2United States
370NCT03162874
(ClinicalTrials.gov)
July 4, 201719/5/2017Study to Evaluate the Efficacy, Safety and Tolerability of PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Parkinson Disease's PatientsA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment With PXT002331 (Foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects With Parkinson's Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED)Parkinson DiseaseDrug: Placebo oral capsule;Drug: PXT002331 - dose 1;Drug: PXT002331 - dose 2Prexton TherapeuticsNULLCompleted35 Years85 YearsAll157Phase 2Austria;France;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371NCT04146519
(ClinicalTrials.gov)
July 1, 201718/10/2019Parkinson's Disease Therapy Using Cell TechnologyDevelopent and Implement a Method of Parkinson's Disease Therapy Using Cell TechnologyTransplantation:Mesenchymal Stem Cell TransplantationBiological: Autologous mesenchymal stem cellsBelarusian Medical Academy of Post-Graduate EducationNULLActive, not recruiting18 YearsN/AAll12Phase 2Belarus
372EUCTR2016-003961-25-DE
(EUCTR)
30/06/201701/02/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
373NCT04403399
(ClinicalTrials.gov)
June 29, 201721/5/2020Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Exp. 3 - Proj#3 (UdallP3)Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Exp. 3 - Proj#3Parkinson's DiseaseDrug: Varenicline;Other: Evaluation by Investigator;Other: PlaceboUniversity of MichiganNULLCompleted45 YearsN/AAll33Phase 2United States
374NCT04223245
(ClinicalTrials.gov)
June 29, 20172/12/2019A Home Program Using Multimodal Sensory Feedback for People With Parkinson DiseaseA Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.Parkinson DiseaseBehavioral: exercise+multi-modal sensory feedback (MMSF);Behavioral: Exercise onlyRegis UniversityNULLCompleted21 YearsN/AAll26N/AUnited States
375NCT03195231
(ClinicalTrials.gov)
June 25, 201720/6/2017Wuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's DiseaseWuling Powder for the Treatment and Underlying Mechanism of Depressive Symptoms in Patients With Parkinson's Disease: a Randomised, Double-blind, Placebo-controlled Trial.Antidepressive AgentsDrug: Wuling Powder;Drug: PlaceboBeijing HospitalTongji Hospital;Shanghai Tong Ren Hospital;The First Hospital of Hebei Medical UniversityNot yet recruiting40 YearsN/AAll120Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376EUCTR2015-005814-31-ES
(EUCTR)
22/06/201721/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
377NCT03116295
(ClinicalTrials.gov)
June 20, 201712/4/2017Bioavailability and Bioequivalence Study of Two Different Sources of OpicaponeA Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy SubjectsParkinson DiseaseDrug: Opicapone (OPC)Bial - Portela C S.A.NULLCompleted18 Years55 YearsAll56Phase 1Germany
378EUCTR2017-000135-14-GB
(EUCTR)
15/06/201717/03/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;United Kingdom
379EUCTR2015-005814-31-HU
(EUCTR)
14/06/201720/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany
380NCT03083132
(ClinicalTrials.gov)
June 13, 20177/3/2017Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)Modafinil as a Novel Therapy for the Treatment of Freezing of Gait in Parkinson's DiseaseParkinson DiseaseDrug: modafinil 50mg;Drug: Placebo oral capsuleUniversity of ArkansasNULLCompleted50 Years90 YearsAll23Early Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381NCT03973502
(ClinicalTrials.gov)
June 12, 201730/5/2019Application of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) With HCV and PDApplication of 18F-FDOPA PET and Magnetic Resonance Spectroscopy (MRS) in Research of the Association Between HCV Infection and Parkinson's Disease.Hepatitis C;Hepatitis B;Parkinson DiseaseDrug: 18F-DOPA PETNational Taiwan University HospitalNULLRecruiting20 YearsN/AAll230N/ATaiwan
382EUCTR2016-003961-25-ES
(EUCTR)
08/06/201727/04/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
383EUCTR2017-000135-14-DE
(EUCTR)
06/06/201710/03/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;Italy;United Kingdom
384EUCTR2016-003961-25-HU
(EUCTR)
31/05/201703/04/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
385EUCTR2017-000135-14-IT
(EUCTR)
30/05/201704/11/2020A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaStudio di fase IIa, multicentrico, in doppio cieco, randomizzato, controllato verso placebo, a gruppi paralleli per valutare l'efficacia, la sicurezza e la tollerabilit¿ del trattamento orale con PXT002331 (foliglurax) della durata di 28 giorni nella riduzione delle complicazioni motorie dovute alla terapia con levodopa nei pazienti affetti da malattia di Parkinson che manifestano deterioramento da fine dose e discinesia indotta da levodopa (AMBLED) - AMBLED Study Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
PREXTON THERAPEUTICS B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2France;Spain;Austria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386EUCTR2017-000135-14-AT
(EUCTR)
26/05/201708/03/2017A study to look at how safe, well tolerated, and what effect on the body, study drug PXT002331 has in patients with Parkinson's Disease who are already taking the drug LevodopaA Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-arm Phase IIa Trial to Evaluate the Efficacy, Safety and Tolerability of 28-Day Oral Treatment with PXT002331 (foliglurax) in Reducing Motor Complications of Levodopa Therapy in Subjects with Parkinson’s Disease Experiencing End-of-dose Wearing Off and Levodopa-Induced Dyskinesia (AMBLED) - AMBLED Study Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Product Name: foliglurax
Product Code: PXT002331
INN or Proposed INN: foliglurax
Other descriptive name: CVD00118-E
Prexton Therapeutics B.V.NULLNot RecruitingFemale: yes
Male: yes
165Phase 2Spain;Austria;Germany;United Kingdom
387EUCTR2015-005814-31-PL
(EUCTR)
25/05/201714/02/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
388NCT03033498
(ClinicalTrials.gov)
May 17, 201725/1/2017A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseA Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted45 Years85 YearsAll29Phase 1United States
389NCT03242499
(ClinicalTrials.gov)
May 15, 20171/8/2017Lovastatin as a Neuroprotective Treatment for Early Stage Parkinson's DiseaseLovastatin as a Neuroprotective Treatment for Early Stage Parkinson's Disease: a Single-center, Double-blind, Placebo-controlled Randomized TrialParkinson DiseaseDrug: Lovastatin;Drug: PlaceboNational Taiwan University HospitalNULLRecruiting30 Years90 YearsAll80Phase 2Taiwan
390NCT03047629
(ClinicalTrials.gov)
May 11, 20173/2/2017Evaluation of Safety and Tolerability of ENT-01 for the Treatment of Parkinson's Disease Related ConstipationA Multi-Center, Single-Dose, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Related ConstipationParkinson's Disease;ConstipationDrug: ENT-01;Other: PlaceboEnterin Inc.NULLCompleted30 Years86 YearsAll50Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391EUCTR2015-004507-23-FI
(EUCTR)
08/05/201730/03/2017Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
392NCT02982512
(ClinicalTrials.gov)
May 1, 201728/11/2016Dexmedetomidine on Basal Ganglia Neuronal Activity in Parkinson's DiseaseEffects of Different Concentrations of Dexmedetomidine on Basal Ganglia Neuronal Activity (Local Field Potentials) in Parkinson's DiseaseDexmedetomidine;Deep Brain Stimulation;Parkinson DiseaseDrug: DexmedetomidineClinica Universidad de Navarra, Universidad de NavarraNULLUnknown status18 YearsN/AAll12Phase 4Spain
393NCT02702076
(ClinicalTrials.gov)
May 20172/3/2016Apomorphine in Parkinson's Disease Patients With Visual HallucinationsRandomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy of Continuous Subcutaneous Infusion in Parkinson's Disease Patients With Refractory Visual HallucinationsParkinson's Disease;Hallucinations, VisualDrug: Apomorphine;Drug: PlaceboUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll35Phase 2Netherlands
394ChiCTR-IPR-17011155
2017-04-202017-04-16Dihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's diseaseDihydroergotoxine mesylate for the treatment of sialorrhea in Parkinson's disease Parkinson’s diseasetreatment group:dihydroergotoxine mesylate 2.5 mg, twice daily, two weeks;intervention group:identical placebo 2.5 mg, twice daily, two weeks;Nanjing First Hospital Affiliated to Nanjing Medical UniversityNULLRecruiting1880Bothtreatment group:10;intervention group:10;China
395NCT03140956
(ClinicalTrials.gov)
April 19, 201712/4/2017Pharmacokinetic of Levodopa Study in Healthy MalesPharmacokinetics of Levodopa After Repeated Doses of Different Pellet Formulations; An Open, Randomized Study With Crossover Design in Healthy Male SubjectsParkinson DiseaseDrug: Levodopa, carbidopa, ODM-104Orion Corporation, Orion PharmaNULLCompleted18 Years65 YearsMale20Phase 1Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396NCT03128450
(ClinicalTrials.gov)
April 15, 20179/2/2017A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease PatientA Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's DiseaseParkinson DiseaseBiological: human neural stem cellSecond Affiliated Hospital of Soochow UniversityNULLEnrolling by invitation35 Years70 YearsAll12Phase 2;Phase 3China
397EUCTR2016-004629-18-NL
(EUCTR)
13/04/201717/01/2017The influence of stress on Parkinson's tremorThe noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor Tremor in Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Radboud University NijmegenNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60Phase 3Netherlands
398NCT03011476
(ClinicalTrials.gov)
April 11, 201727/12/2016Effect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson DiseaseEffect of Acetylcholinesterase Inhibitors on the Gait of the Patients With Parkinson Disease Characterized by Postural Instability and Gait DisturbanceParkinson DiseaseDrug: Donepezil;Drug: PlacebosKyung Hee University HospitalNULLUnknown status40 Years75 YearsAll20Phase 4Korea, Republic of
399EUCTR2016-003961-25-GB
(EUCTR)
04/04/201716/02/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biotie TherapiesNULLNot Recruiting Female: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
400JPRN-UMIN000026128
2017/04/0101/04/2017Association between pupillary autonomic dysfunction and visual hallucination in Parkinson's disease Parkinson's diseaseadministe pilocarpine and dipivefrine
administe pilocarpine and dipivefrine
Nagoya UniversityNULLRecruiting40years-old90years-oldMale and Female60Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401EUCTR2016-001403-23-GR
(EUCTR)
31/03/201714/10/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
402NCT02970019
(ClinicalTrials.gov)
March 30, 201718/11/2016Safety and Tolerability Study of K0706 in Subjects With Parkinson's DiseaseA Double-blind, Placebo-controlled Study to Determine Safety, Tolerability, Pharmacokinetic of K0706.Parkinson DiseaseDrug: K0706;Drug: PlaceboSun Pharma Advanced Research Company LimitedNULLCompleted18 Years65 YearsAll60Phase 1United States
403EUCTR2016-003456-70-GB
(EUCTR)
22/03/201726/01/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorp
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;Italy;United Kingdom
404EUCTR2016-001575-71-ES
(EUCTR)
16/03/201717/01/2017A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASEA 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE Parkinson's Disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Pfizer, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Israel;Germany
405EUCTR2015-003513-24-SK
(EUCTR)
14/03/201704/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406NCT02864004
(ClinicalTrials.gov)
March 3, 201715/7/2016Apomorphine Pump in Early Stage of Parkinson's Disease (EARLY-PUMP)Apomorphine Pump in Early Stage of Parkinson's DiseaseParkinson's DiseaseDrug: Apomorphine;Other: Best Medical TreatmentRennes University HospitalNULLRecruiting18 Years65 YearsAll192Phase 3France
407EUCTR2015-005814-31-CZ
(EUCTR)
03/03/201701/12/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
210Phase 2France;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
408EUCTR2015-004507-23-HU
(EUCTR)
24/02/201704/01/2017Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
409EUCTR2016-001403-23-FI
(EUCTR)
22/02/201731/08/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
410NCT03068481
(ClinicalTrials.gov)
February 20, 201726/2/2017Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's DiseaseA Phase I Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's DiseaseParkinson DiseaseDrug: KDT-3594;Drug: PlaceboKissei Pharmaceutical Co., Ltd.NULLCompleted20 Years74 YearsAll36Phase 1Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411EUCTR2016-000657-12-IT
(EUCTR)
16/02/201708/02/2017A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: 000000
Other descriptive name: Genz-682452-AU
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: 00000
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 2Portugal;United States;Taiwan;Spain;Austria;Israel;Italy;United Kingdom;France;Canada;Singapore;Australia;Norway;Germany;Japan;Sweden
412NCT02799381
(ClinicalTrials.gov)
February 9, 201710/6/2016A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)Parkinson's Disease (PD)Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tubeAbbVieNULLCompleted30 YearsN/AAll63Phase 3United States;Finland;Greece;Hungary;Italy;Slovakia;Spain
413EUCTR2015-005814-31-DE
(EUCTR)
07/02/201724/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
414EUCTR2015-004344-19-DE
(EUCTR)
07/02/201727/09/2016An international trial of deferiprone in patients with Parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ApoPharmaNULLNot Recruiting Female: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
415JPRN-UMIN000025645
2017/02/0117/01/2018Cross sectional analysis of Intestinal flora of Parkinson's disease: Parkinson's diseaseLevodopa/carbidopa intestinal gelJuntendo University School of MedicineNULLPendingNot applicableNot applicableMale and Female20Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416NCT03119194
(ClinicalTrials.gov)
January 27, 201713/4/2017Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male SubjectsParkinson DiseaseDrug: [14C]-BIA 9-1067Bial - Portela C S.A.NULLCompleted30 Years65 YearsMale7Phase 1United Kingdom
417EUCTR2016-000657-12-DE
(EUCTR)
26/01/201717/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
418EUCTR2016-000657-12-PT
(EUCTR)
09/01/201725/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
290Phase 2Portugal;United States;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Norway;Germany;Japan;Sweden
419ChiCTR-DDD-16009569
2017-01-012016-10-24Differential diagnosis of primary Parkinson's disease by 18F-FDG combined with 11C-ß-CFT PET / CT imagingDifferential diagnosis of primary Parkinson's disease by 18F-FDG combined with 11C-ß-CFT PET / CT imaging Parkinson's DiseaseGold Standard:;Index test:;Renji hospital, School of Medicine, Shanghai Jiao Tong UniversityNULLPending2080BothTarget condition:0;Difficult condition:0China
420NCT03037203
(ClinicalTrials.gov)
January 201723/1/2017A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessA 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessExcessive Sleepiness;Parkinson DiseaseDrug: JZP-110;Other: PlaceboJazz PharmaceuticalsNULLCompleted35 Years80 YearsAll66Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421NCT03034564
(ClinicalTrials.gov)
January 201725/1/2017A Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled Study of Droxidopa for Fatigue in Parkinson's DiseaseParkinson Disease;Fatigue;ParkinsonismDrug: Northera;Drug: Placebo Oral TabletThe Cooper Health SystemNULLRecruiting18 YearsN/AAll70Phase 4United States
422NCT02954978
(ClinicalTrials.gov)
January 20171/11/2016Impact of Nilotinib on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Study to Evaluate the Impact of Low Doses of Nilotinib Treatment on Safety, Tolerability, Pharmacokinetics and Biomarkers in Parkinson's DiseaseParkinson Disease;Parkinsons Disease With DementiaDrug: Placebo Oral Capsule;Drug: Nilotinib 150mg oral capsule [Tasigna];Drug: Nilotinib 300mg oral capsule [Tasigna]Georgetown UniversityNULLActive, not recruiting40 Years90 YearsAll75Phase 2United States
423NCT02969369
(ClinicalTrials.gov)
December 31, 201617/11/2016A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisA Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: SEP-363856;Drug: Placebo capsuleSunovionNULLCompleted55 Years105 YearsAll39Phase 2United States
424EUCTR2016-001575-71-DE
(EUCTR)
23/12/201626/09/2016A 15-WEEK CLINICAL STUDY TO DETERMINE THE EFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH EARLY PARKINSON’S DISEASEA 15 WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON’S DISEASE Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Pfizer, Inc.NULLNot RecruitingFemale: yes
Male: yes
88Phase 2France;United States;Spain;Israel;Germany
425ChiCTR-IOR-16010168
2016-12-202016-12-15Propofol-remifetanyl vs dexmedetomidine continous infusion for deep brain stimulation implantationPropofol-remifetanyl vs dexmedetomidine continous infusion for deep brain stimulation implantation Parkinson's Diseasepropofol-remifentanyl group:propofol-remifentany infusion for monitored anesthesia care during awake deep brain stimulation surgery;dexmedetomidine group:dexmedetomidine infusion for monitored anesthesia care during awake deep brain stimulation surgery;West China Hospital, Sichuan UniversityNULLRecruiting18Bothpropofol-remifentanyl group:25;dexmedetomidine group:25;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426EUCTR2016-002033-30-BE
(EUCTR)
19/12/201621/11/2016A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
427NCT02906020
(ClinicalTrials.gov)
December 15, 201614/9/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of Venglustat (GZ/SAR402671) in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients With Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant.Parkinson's DiseaseDrug: GZ/SAR402671;Drug: PlaceboGenzyme, a Sanofi CompanyNULLActive, not recruiting18 Years80 YearsAll270Phase 2United States;Austria;Canada;France;Germany;Greece;Israel;Italy;Japan;Norway;Portugal;Singapore;Spain;Sweden;Taiwan;United Kingdom
428JPRN-UMIN000024859
2016/12/1416/11/2016The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide.The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. - The effectiveness of motor and psychiatric symptoms for Parkinson's disease patients by switching from Dopamine agonist to Zonisamide or combining Dopamine agonist and Zonisamide. Parkinson's diseaseSwitching from Dopamine agonist to Zonisamide.

Intervention period of 12 weeks.
Medical Corporation Abe Neurology ClinicNULLComplete: follow-up continuing30years-oldNot applicableMale and Female50Not applicableJapan
429ChiCTR2000037957
2016-12-012020-09-07Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's diseaseClinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease Deep brain stimulation in patients with Parkinson's diseaseExperimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline;Shanghai Jing'an District Central HospitalNULLCompleted4575BothExperimental group:27;control group:9;China
430NCT02934919
(ClinicalTrials.gov)
December 201614/10/2016Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label StudyEvaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label StudyImpulse Control Disorders;Parkinson DiseaseDrug: NalmefeneUniversity Hospital, Clermont-FerrandNULLNot yet recruiting18 Years80 YearsBoth30Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT02879136
(ClinicalTrials.gov)
December 201623/6/2016TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's DiseaseTAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot StudyParkinson's Disease, IdiopathicDrug: Methylphenidate;Other: Physical Therapy;Drug: AtomoxetineHubert FernandezNULLRecruiting18 Years90 YearsAll42Early Phase 1United States
432NCT03000569
(ClinicalTrials.gov)
November 30, 201628/11/2016A Study to Evaluate SAGE-217 in Participants With Parkinson's DiseaseA Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: SAGE-217;Drug: Levodopa;Drug: Antiparkinsonian Agent(s)Sage TherapeuticsNULLCompleted40 Years75 YearsAll29Phase 2United States
433EUCTR2016-001403-23-SK
(EUCTR)
29/11/201607/09/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60Phase 3United States;Hungary;European Union;Slovakia;Greece;Finland;Spain
434EUCTR2016-002033-30-FR
(EUCTR)
29/11/201612/01/2017A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
150Phase 3United States;France;Hungary;Canada;Belgium;Spain;Denmark;Israel;Netherlands;United Kingdom;Sweden
435JPRN-UMIN000024536
2016/11/2825/10/2016Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) Parkinson's diseaseTreatment with istradefylline combined with optimal medical therapy.

Treatment with istradefylline will be started at a dose of 20 mg administered once daily at Week 0. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4.

From the following day of Week 4, Optimal medical therapy including istradefylline will be applied to each patient.
Optimal medical therapy without istradefylline.

Treatment with increased dose of previously used antiparkinson drugs or addition of new antiparkinson drug other than istradefylline will be started at Week 0.

After Week 4, Optimal medical therapy without istradefylline will be applied to each patient.
Fukuoka UniversityNULLComplete: follow-up complete30years-old80years-oldMale and Female280Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436EUCTR2016-001690-33-FI
(EUCTR)
25/11/201623/11/2016Apomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossaApomorfiini-infuusiohoito edenneen Parkinsonin taudin hoidossa Edennyt parkinsonin tauti
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Dacepton 5 mg/ml infuusioneste, liuos
Product Name: Dacepton 5 mg/ml
Eero PekkonenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland
437EUCTR2015-004912-39-ES
(EUCTR)
25/11/201617/05/2016A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASE Parkinson's Disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Pfizer, Inc.NULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Spain;Germany;Japan;United Kingdom
438NCT02847442
(ClinicalTrials.gov)
November 23, 201621/7/2016Efficacy and Safety of Opicapone in Clinical PracticeEfficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor FluctuationsParkinson's Disease With Wearing-off Motor FluctuationsDrug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitorBial - Portela C S.A.NULLCompleted30 YearsN/AAll518Phase 4Germany
439EUCTR2016-000102-11-NL
(EUCTR)
23/11/201608/11/2016Trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations.Randomized, double-blind, placebo-controlled trial to evaluate the efficacy of continuous subcutaneous apomorphine infusion in Parkinson’s disease patients with refractory visual hallucinations. - Apomorphine in PD patients with visual hallucinations: a RCT Parkinson's disease patients with refractory visual hallucinations
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: APO-go
Product Name: Apomorphine
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2;Phase 3Netherlands
440EUCTR2016-001403-23-ES
(EUCTR)
14/11/201615/11/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;European Union;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT03007888
(ClinicalTrials.gov)
November 14, 20166/12/2016A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseA Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: IR CD-LD;Drug: ER CD-LDImpax Laboratories, LLCNULLCompleted40 Years100 YearsAll28Phase 2United States
442EUCTR2016-000657-12-SE
(EUCTR)
09/11/201612/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Germany;Norway;Japan;Sweden
443EUCTR2016-001762-29-IT
(EUCTR)
08/11/201625/05/2017A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)A Phase 2, Randomized, Double-Blind, Placebo Controlled, 3-Period Crossover, Positive Control, QT-Evaluation Study of APL-130277 in Subjects with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes) - CTH-201 Parkinson's Disease (PD)
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Product Name: APL-130277
Product Code: APL-130277
INN or Proposed INN: Apomorphine Hydrocloride Hemihydrate
Other descriptive name: Apomorphine Hydrocloride
Trade Name: AVALOX - 400 MG COMPRESSE RIVESTITE CON FILM 5 COMPRESSE IN BLISTER PP/AL
Product Name: Avalox
Product Code: n.a.
INN or Proposed INN: MOXIFLOXACINA CLORIDRATO
SUNOVION PHARMACEUTICALSNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Italy
444NCT03531060
(ClinicalTrials.gov)
November 8, 201610/4/2018A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced DyskinesiaA Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).Parkinson DiseaseDrug: IRL790;Drug: PlaceboIntegrative Research Laboratories ABNULLCompleted50 Years85 YearsAll15Phase 1;Phase 2NULL
445EUCTR2016-002033-30-ES
(EUCTR)
03/11/201625/08/2016A clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: Levodopa
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;France;Canada;Belgium;Spain;Denmark;Israel;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446JPRN-UMIN000025638
2016/11/0116/01/2017Adenosine A2A receptors in Parkinson's disease Parkinson's disease11C-preladenant-PET scanningTokyo Metropolitan Institute of GerontologyNULLComplete: follow-up complete40years-old89years-oldMale and Female40Not selectedJapan
447ChiCTR-IPR-16009395
2016-11-012016-10-14Clinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stageClinical trial on efficacy and safety of add-on treatment of Butylphthalide in patients with Parkinson's disease in early and moderate stage Parkinson’s diseaseButylphthalide group and Control group:Butylphthalide 200mg/time(2 capsules) , three time/day, for 24 weeks;Control:No treatment;The Second Affiliated Hospital of Soochow UniversityNULLPending35BothButylphthalide group and Control group:36;Control:36;China
448NCT02968433
(ClinicalTrials.gov)
November 201614/11/2016The Stanford Parkinson's Disease Plasma StudyThe Stanford Parkinson's Disease Plasma (SPDP) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Moderate Parkinson's DiseaseParkinson Disease(PD)Drug: Infusions of young plasmaStanford UniversityNULLActive, not recruiting50 Years80 YearsAll15Phase 1United States
449NCT03022799
(ClinicalTrials.gov)
November 201627/12/2016Phase I, KM-819 in Healthy Subjects for Parkinson's DiseaseA First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly SubjectsParkinson's DiseaseDrug: KM-819;Drug: PlaceboKainos Medicine Inc.NULLCompleted19 Years45 YearsAll88Phase 1Korea, Republic of
450NCT02857244
(ClinicalTrials.gov)
November 201625/7/2016A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsA Multidisciplinary Approach to Manage Gait Difficulty in Parkinson PatientsParkinson's DiseaseDrug: Duloxetine;Drug: Donepezil;Drug: ModafinilUniversity of ChicagoNULLWithdrawn18 Years100 YearsAll0Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451EUCTR2015-001786-10-DE
(EUCTR)
24/10/201607/04/2016A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot Recruiting Female: yes
Male: yes
40Phase 2United States;Germany;United Kingdom
452NCT02871427
(ClinicalTrials.gov)
October 20, 201615/8/2016Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior DisorderAn Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior DisorderLewy Body Dementia;Dementia With Lewy Bodies;Parkinson's Disease Dementia;Visual Hallucinations;REM Sleep Behavior DisorderDrug: NelotanserinAxovant Sciences Ltd.NULLTerminated50 YearsN/AAll80Phase 2United States
453EUCTR2016-000657-12-ES
(EUCTR)
20/10/201624/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: NA
Other descriptive name: Genz-682452-AU
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: NA
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
276Phase 2United States;Portugal;Taiwan;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden
454EUCTR2016-002680-34-ES
(EUCTR)
20/10/201605/08/2016Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease.Effects of different concentrations of dexmedetomidine on basal ganglia neuronal activity (local field potentials) in Parkinson's disease. Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trade Name: Dexdor
Product Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Other descriptive name: DEXMEDETOMIDINA
Clínica Universidad de Navarra/Universidad de NavarraNULLNot RecruitingFemale: yes
Male: yes
12Phase 4Spain
455EUCTR2016-002454-20-FR
(EUCTR)
17/10/201616/03/2017Apomorphine Pump in Early Stage of Parkinson’s DiseaseApomorphine Pump in Early Stage of Parkinson’s Disease - EARLY-PUMP Parkinson’s disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: APOKINON
Product Name: APOKINON
CHU de RennesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456NCT02847650
(ClinicalTrials.gov)
October 17, 201625/7/2016Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients at Early Stage of the DiseaseA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, FLEXIBLE DOSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH EARLY STAGE PARKINSON'S DISEASEParkinson DiseaseDrug: Placebo;Drug: PF-06649751PfizerNULLTerminated45 Years80 YearsAll57Phase 2United States;France;Germany;Israel
457EUCTR2015-002571-24-GB
(EUCTR)
14/10/201612/02/2019A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease. A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Joint Research OfficeNULLNot Recruiting Female: yes
Male: yes
20Phase 2United Kingdom
458NCT02728843
(ClinicalTrials.gov)
October 12, 201631/3/2016Study of Parkinson's Early Stage With DeferiproneA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone;Drug: PlaceboApoPharmaNULLCompleted18 Years80 YearsAll140Phase 2Canada;France;Germany;United Kingdom
459EUCTR2016-002391-27-GB
(EUCTR)
07/10/201604/08/2016Opicapone in clinical practice (OPTIPARK)This action will amend the information submitted in this data field for all relevant applications. Please refer to the guidance under the Amendment tab and consider whether further notification to review bodies is required. - Opicapone in clinical practice (OPTIPARK)_V1 Parkinson's disease (PD) patients with wearing-off motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
BIAL - Portela & Ca, S.A.NULLNot Recruiting Female: yes
Male: yes
550Phase 4Germany;United Kingdom
460EUCTR2016-002391-27-DE
(EUCTR)
05/10/201605/08/2016OPTIPARKEfficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations Parkinson's disease (PD) patients with wearing-off motor fluctuations;Therapeutic area: Not possible to specifyBIAL - Portela & Ca, S.A.NULLNot Recruiting Female: yes
Male: yes
550Phase 4Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT02935842
(ClinicalTrials.gov)
October 1, 201618/8/2016Evaluation of Intensive Language TherapyEffectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded TrialParkinson's DiseaseOther: Specific SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT)University Hospital, Basel, SwitzerlandNULLCompleted45 Years80 YearsAll38N/ASwitzerland
462NCT02940912
(ClinicalTrials.gov)
October 201614/10/2016Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseDouble Bind Randomized Placebo-controlled Cross-over Study to Evaluate Effect of Continuous Apomorphine During the Night on Sleep Disorders in Insomniac Patients With Parkinson's DiseaseParkinson DiseaseDrug: Apomorphine;Drug: PlaceboClinique Beau SoleilNULLRecruiting35 Years90 YearsAll45Phase 4France
463NCT02910102
(ClinicalTrials.gov)
October 201616/9/2016Study Evaluating Intepirdine (RVT-101) on Gait and Balance in Subjects With DementiaA Phase 2, Double-blind, Randomized, Placebo-controlled Crossover Study Evaluating the Effect of RVT-101 on Gait and Balance in Subjects With Alzheimer's Disease, Dementia With Lewy Bodies, or Parkinson's Disease DementiaAlzheimer's Disease;Dementia With Lewy Bodies;Parkinson's Disease DementiaDrug: RVT-101 35 mg;Drug: PlaceboAxovant Sciences Ltd.NULLCompleted50 Years89 YearsAll38Phase 2United States
464NCT03462680
(ClinicalTrials.gov)
September 28, 201622/2/2018GPR109A and Parkinson's Disease: Role of Niacin in Outcome MeasuresGPR109A and Parkinson's Disease: Role of Niacin in Outcome MeasuresParkinson's DiseaseDietary Supplement: niacin;Other: placeboVA Office of Research and DevelopmentNULLCompleted35 YearsN/AAll47N/AUnited States
465EUCTR2015-005078-39-DE
(EUCTR)
21/09/201602/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
466JPRN-UMIN000024312
2016/09/2025/05/2017Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
467EUCTR2015-003513-24-DE
(EUCTR)
08/09/201615/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
468NCT02688465
(ClinicalTrials.gov)
September 5, 201618/2/2016Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).Parkinson's DiseaseDrug: ApomorphineFondation Ophtalmologique Adolphe de RothschildNULLTerminated18 YearsN/AAll15Phase 4France
469NCT02385500
(ClinicalTrials.gov)
September 20164/3/2015Fesoterodine on Urgency Episodes in Parkinson's Disease PopulationRandomized Cross-Over Study of Fesoterodine on Urgency Episodes in Parkinson's Disease PopulationUrinary Bladder, Overactive;Parkinson DiseaseDrug: Fesoterodine;Drug: PlaceboSir Mortimer B. Davis - Jewish General HospitalNULLTerminated50 Years85 YearsAll5Phase 4Canada
470NCT02897063
(ClinicalTrials.gov)
September 20167/9/2016Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic FailureThe Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure Aim 2 of RDCRN (Rare Diseases Clinical Research Network) Project 2Autonomic Failure;Pure Autonomic Failure;Multiple System Atrophy;Parkinson Disease;Orthostatic HypotensionDrug: Droxidopa;Drug: Midodrine;Drug: PlaceboVanderbilt University Medical CenterNULLRecruiting40 Years80 YearsAll34Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471NCT02601586
(ClinicalTrials.gov)
September 201617/8/2015Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's DiseaseEvaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA TrialParkinson DiseaseDrug: PR Oxycodone;Drug: Levodopa;Drug: Oxycodone Placebo;Drug: Levodopa placeboUniversity Hospital, ToulouseNULLRecruiting40 Years75 YearsAll84Phase 2;Phase 3France
472NCT02939391
(ClinicalTrials.gov)
September 201617/10/2016A Study of KW-6356 in Subjects With Early Parkinson's DiseaseAn Early Phase 2 Study of KW-6356 in Subject With Early Parkinson's DiseaseParkinson's DiseaseDrug: KW-6356;Drug: PlaceboKyowa Kirin Co., Ltd.NULLCompleted20 Years80 YearsAll175Phase 2Japan
473EUCTR2015-005814-31-AT
(EUCTR)
29/08/201611/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
474EUCTR2015-003679-31-NL
(EUCTR)
09/08/201624/05/2016New therapeutic strategy in Parkinson’s diseaseConservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Deferiprone DR
INN or Proposed INN: DEFERIPRONE
Centre Hospitalier Régional et Universitaire de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Portugal;Spain;Austria;Netherlands
475NCT02782481
(ClinicalTrials.gov)
August 201622/5/2016A Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor FluctuationsA Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Group Clinical Study Investigating the Efficacy, Tolerability, and Safety of Continuous Subcutaneous ND0612 Infusion Given as Adjunct Treatment to Oral Levodopa in Patients With Parkinson's Disease With Motor FluctuationsParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLWithdrawn30 Years80 YearsAll0Phase 3Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476EUCTR2014-001014-25-ES
(EUCTR)
20/07/201615/07/2016Brain amyloid beta burden as per florbetaben PETBrain Amyloid-Beta burden as per florbetaben (Neuraceq) pet and cognitive outcomes after deep brain stimulation in Parkinsin's disease Parkinson's Disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neuraceq
Product Name: Neuraceq
INN or Proposed INN: FLORBETABEN (18F)
Fundació Clínic per la Recerca BiomèdicaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Spain
477ChiCTR-DOC-16008645
2016-07-012016-06-15The study of radionuclide imaging and biomarkers in clinical diagnosis and treatment of Parkinson's diseaseThe study of radionuclide imaging and biomarkers in clinical diagnosis and treatment of Parkinson's disease Parkinson DiseaseGold Standard:;Index test:;101th Hospital of PLANULLPending1880BothTarget condition:0;Difficult condition:0NULL
478ChiCTR-DRD-16008778
2016-07-012016-07-04The study of Parkinson's disease imaging biomarkers based on MR with high resolution and multi modeThe study of Parkinson's disease imaging biomarkers based on MR with high resolution and multi mode Parkinson`s DiseaseGold Standard:;Index test:;Xiangyang Hospital, Hubei University of MedicineNULLRecruitingBothTarget condition:0;Difficult condition:0China
479NCT02382198
(ClinicalTrials.gov)
July 201621/1/2015Study of Glycopyrrolate for Moderate-to-severe Sialorrhea in Parkinson's DiseaseA Randomized, Placebo-controlled, 2-arm Parallel-group Superiority Phase II Study of GLYCOpyrrolate for Moderate-to-severe Sialorrhea in PARkinson's DiseaseSialorrhea;Parkinson's DiseaseDrug: Glycopyrrolate;Drug: PlaceboOttawa Hospital Research InstituteNULLUnknown status30 YearsN/AAll28Phase 2Canada
480NCT02615873
(ClinicalTrials.gov)
July 201623/11/2015A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004Parkinson's DiseaseDrug: Accordion Pill™ Carbidopa/LevodopaIntec Pharma Ltd.NULLUnknown status30 Years100 YearsAll460Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481NCT02452723
(ClinicalTrials.gov)
July 201618/5/2015A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's DiseaseA Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's DiseaseParkinson DiseaseBiological: ISC-hpNSCCyto Therapeutics Pty LimitedNULLActive, not recruiting30 Years70 YearsAll12Phase 1Australia
482EUCTR2015-004344-19-FR
(EUCTR)
29/06/201620/04/2016An international trial of deferiprone in patients with parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ApoPharma Inc.NULLNot Recruiting Female: yes
Male: yes
140Phase 2United States;France;Canada;Germany;Italy;United Kingdom
483EUCTR2015-003513-24-BG
(EUCTR)
27/06/201626/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
484EUCTR2015-003513-24-IT
(EUCTR)
23/06/201605/11/2020OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [NA]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [NA]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy
485EUCTR2015-005626-19-CZ
(EUCTR)
23/06/201614/04/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301 35mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301 50mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Czech Republic;Canada;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486EUCTR2015-003679-31-CZ
(EUCTR)
23/06/201628/01/2016New therapeutic strategy in Parkinson’s diseaseConservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Deferiprone DR
INN or Proposed INN: DEFERIPRONE
Centre Hospitalier Régional et Universitaire de LilleNULLNot RecruitingFemale: yes
Male: yes
338Phase 2Portugal;Czech Republic;Spain;Austria;Netherlands
487EUCTR2015-003512-20-PL
(EUCTR)
22/06/201601/04/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
488EUCTR2015-004912-39-DE
(EUCTR)
14/06/201611/02/2016A 15-WEEK CLINICAL STUDY TO DETERMINE THEEFFECTIVENESS, SAFETY AND TOLERABILITY OF PF-06649751 IN PATIENTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THEEFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Product Name: PF-06649751
Product Code: PF-06649751
INN or Proposed INN: PF-06649751
Other descriptive name: PF-06649751
Pfizer, Inc.NULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Spain;Germany;Japan;United Kingdom
489EUCTR2015-005626-19-ES
(EUCTR)
13/06/201620/04/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301 35mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301 50mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, a wholly owned subsidiary of AcordaNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Czech Republic;Canada;Poland;Spain
490JPRN-jRCTs051180098
09/06/201606/03/2019The DAT-SPECT study for the benefit of Selegilline or Zonisamide in Parkinson's DiseaseA comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease Parkinson's disease;034034L-Dopa/DCI only : The drug is administered per oral at 300 mg/day. The treatment is started within 14 days after registration and continued until day 365.
L-Dopa/DCI + selegiline : L-Dopa/DCI is administered per oral at 300 mg/day and selegiline is administered at 5 mg/day. The treatment is started within 14 days after registration and continued until day 365.
L-Dopa/DCI + zonisamide : L-Dopa/DCI is administered per oral at 300 mg/day and zonisamide is administered at 25 mg/day. The treatment is started within 14 days after registration and continued until day 365.
Ito HidefumiNULLRecruiting>= 55age old< 80age oldBoth120Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491EUCTR2015-003512-20-IT
(EUCTR)
08/06/201605/11/2020Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852
MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
492JPRN-UMIN000022533
2016/06/0101/06/2016A comparative randomized study for the evaluation of the overlaying effect of Selegiline or Zonisamide over Levodopa in Parkinson's disease Parkinson's diseaseL-Dopa/DCI only
The drug is administered per oral at 150 to 300 mg/day. The treatment is started within 14days after registration and continued until day 365.
L-Dopa/DCI + selegiline
L-Dopa/DCI is administered per oral at 150 to 300 mg/day and selegiline is administered at 5mg/day. The treatment is started within 14days after registration and continued until day 365.
L-Dopa/DCI + zonisamide
L-Dopa/DCI is administered per oral at 150 to 300 mg/day and zonisamide is administered at 25mg/day. The treatment is started within 14days after registration and continued until day 365.
Osaka Redcross HospitalWakayama Prefectural Medical CollegeNULLRecruiting55years-old80years-oldMale and Female180Phase 2Japan
493JPRN-UMIN000022529
2016/06/0101/06/2016Effects on the pharmacokinetics of L-DOPA formulation by Proton pump inhibitors in patients with Parkinson's disease Parkinson's disease8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg)
Washout 6days

8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap
8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium Placebo Capsules(lactose,once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium Placebo Capsules 2Cap
Washout 6days

8-day oral administration of L-DOPA formulation(Menesit100 Tablets or DopacolL100 Tablets,dosage in taking)and Nexium10 Capsules(once a day 2Cap,after breakfast)

Blood concentration measurement date only, oral administration of L-DOPA formulation 1tablet(100mg) and Nexium10 2Cap(20mg)
Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up complete20years-old85years-oldMale and Female8Phase 3Japan
494NCT02812394
(ClinicalTrials.gov)
June 201622/6/2016A Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) TabletsA Phase 1 Single Dose Pharmacokinetic Bridging Study to Compare Two Dose Strengths of CVT-301 (Levodopa Inhalation Powder) With an Oral Dose of Sinemet® (Carbidopa-levodopa) TabletsParkinson DiseaseDrug: CVT-301 (Dose Level 1);Drug: CVT-301 (Dose Level 2);Drug: Sinemet®Acorda TherapeuticsNULLCompleted25 Years65 YearsBoth24Phase 1United States
495NCT02807675
(ClinicalTrials.gov)
June 201617/6/2016A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301, LIP;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll36Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496NCT02785978
(ClinicalTrials.gov)
June 201611/5/2016Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy VolunteersPilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy VolunteersParkinson Disease;Healthy VolunteersDrug: Levodopa acute challenge;Other: Controlled environment tests (series of tasks of everyday life);Other: Standardized scales: MDS-UPDRS (Part II to IV) and RDRS;Device: ActiMyo recording;Other: Diary completionInstitut de Myologie, FranceNULLCompleted18 YearsN/AAll30N/AFrance
497EUCTR2016-000679-25-ES
(EUCTR)
31/05/201618/03/2016Clinical study for the assessment of security of candesartan in Parkinson?s disease population and its potential benefit in cognitive impairment associated to Parkinson?s disease.A prospective, randomized, double-blind and placebo-controlled, parallel group, phase II study to compare the efficacy and safety of candesartan versus placebo on cognitive impairment associated with Parkinson?s disease. Exploratory study. Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]INSTITUT DE RECERCA HSCSPNULLNot Recruiting Female: yes
Male: yes
56Phase 2Spain
498JPRN-UMIN000009062
2016/05/3009/10/2012An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease Parkinson's diseaseTake oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dLDept. of Clinical pharmacology and NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 1Japan
499EUCTR2015-005078-39-AT
(EUCTR)
30/05/201609/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced Parkinson's disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
500EUCTR2015-003513-24-HU
(EUCTR)
24/05/201602/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501EUCTR2015-003512-20-ES
(EUCTR)
18/05/201618/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
502EUCTR2015-003513-24-ES
(EUCTR)
18/05/201618/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
503EUCTR2016-000636-18-GB
(EUCTR)
12/05/201604/03/2016 Phase 3, placebo controlled study to examine the efficacy, safety and tolerability of APL-130277 in patients with Parkinson's disease. A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 19.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sunuvion Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
126Phase 3United States;Canada;United Kingdom
504EUCTR2016-000637-43-GB
(EUCTR)
12/05/201604/03/2016Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom
505JPRN-UMIN000022022
2016/05/1010/05/2016A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson diseaseA randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease - A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease Parkinson diseaseChronic constipationStudy drug group:
A 12-week administration of lubiprostone 24 microrgrum (adjustable) twice daily after switching from magnesium oxide

Control group:
Continuous administration of magnesium oxide at the same dosage regimen as before the enrollment
Dokkyo Medical UniversityNULLComplete: follow-up complete20years-old90years-oldMale and Female64Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
506JPRN-UMIN000022023
2016/05/1010/05/2016A randomized controlled study comparing lubiprostone and magnesium oxide for treatment of chronic constipation in patients with Parkinson disease. -to evaluation by change of intestinal bacterial flora- Parkinson diseaseChronic constipationStudy drug group:
A 12-week administration of lubiprostone 24 microgrum (adjustable) twice daily after switching from magnesium oxide

Control group:
Continuous administration of magnesium oxide at the same dosage regimen as before the enrollmen
Dokkyo Medical UniversityNULLComplete: follow-up complete20years-old90years-oldMale and Female64Not selectedJapan
507EUCTR2015-003512-20-HU
(EUCTR)
09/05/201602/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
508EUCTR2015-003887-34-PL
(EUCTR)
06/05/201626/02/2016A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease Moderate to severe Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
509JPRN-UMIN000022187
2016/05/0606/05/2016Research on Parkinson's disease pathogenesis based on analysis of caffeine absorption in patients with Parkinson's disease Parkinson&#39;s diseasePD group, 200 mg caffeine administration, qd, 1 day
Control group, 200 mg caffeine administration, qd, 1 day
Department of Neurology, Juntendo UniversityNULLComplete: follow-up complete40years-old60years-oldMale and Female20Not applicableJapan
510NCT02762591
(ClinicalTrials.gov)
May 3, 20163/5/2016Expanded Access of Pimavanserin for Patients With PD PsychosisExpanded Access Program of Pimavanserin in Patients With Parkinson's Disease PsychosisParkinson's Disease PsychosisDrug: Pimavanserin tartrateACADIA Pharmaceuticals Inc.NULLApproved for marketing40 YearsN/AAllN/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511NCT02726386
(ClinicalTrials.gov)
May 201629/3/2016A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC InfusionA Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612NeuroDerm Ltd.NULLActive, not recruiting30 YearsN/AAll210Phase 2United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain
512NCT02728947
(ClinicalTrials.gov)
May 201631/3/2016Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's DiseaseA Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's DiseaseParkinson's DiseaseDrug: ROTIGOTINELuye Pharma Group Ltd.NULLCompleted18 Years99 YearsBoth28Phase 1United States
513NCT02705755
(ClinicalTrials.gov)
May 20167/3/2016TD-9855 Phase 2 in Neurogenic Orthostatic Hypotension (nOH)A Phase 2 Study to Assess the Effect of TD-9855 in Subjects With Neurogenic Orthostatic HypotensionNeurogenic Orthostatic Hypotension;Multiple System Atrophy (MSA) With Orthostatic Hypotension;Pure Autonomic Failure;Parkinson Disease;Hypotension, Orthostatic;Orthostatic Hypotension;Pure Autonomic Failure With Orthostatic Hypotension;Parkinson Disease With Orthostatic HypotensionDrug: TD-9855;Drug: PlaceboTheravance BiopharmaNULLCompleted40 YearsN/AAll34Phase 2United States
514NCT02784145
(ClinicalTrials.gov)
May 201617/5/2016Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseEffects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseParkinson DiseaseDietary Supplement: Resistant starch;Other: Recommendation with regard to nutritionSaarland UniversityNULLCompleted18 YearsN/AAll95N/AGermany
515EUCTR2015-003513-24-GB
(EUCTR)
28/04/201604/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516EUCTR2015-003512-20-GB
(EUCTR)
28/04/201603/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
517EUCTR2015-004507-23-DE
(EUCTR)
25/04/201613/01/2016Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
518EUCTR2015-003512-20-SK
(EUCTR)
22/04/201604/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
519EUCTR2015-003679-31-PT
(EUCTR)
18/04/201628/01/2016New therapeutic strategy in Parkinson’s diseaseConservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Deferiprone DR
INN or Proposed INN: DEFERIPRONE
Centre Hospitalier Régional et Universitaire de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
338Phase 2Portugal;Czech Republic;Spain;Austria;Netherlands
520EUCTR2014-005630-60-AT
(EUCTR)
12/04/201604/12/2015A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tozadenant
Product Code: SYN115
INN or Proposed INN: Tozadenant
Other descriptive name: TOZADENANT
Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521EUCTR2015-003887-34-DE
(EUCTR)
12/04/201623/12/2015A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease Moderate to severe Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
522NCT02764125
(ClinicalTrials.gov)
April 8, 201613/1/2016Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-offParkinson's DiseaseDrug: Stalevo;Drug: levodopa MROrion Corporation, Orion PharmaNULLCompleted30 YearsN/AAll84Phase 2Finland;Germany;Hungary;Latvia
523NCT03034538
(ClinicalTrials.gov)
April 8, 201625/1/2017An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's DiseaseAn Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's DiseaseParkinson Disease;Parkinsonism;DyskinesiasDrug: ZonegranThe Cooper Health SystemNULLRecruiting18 YearsN/AAll20Phase 4United States
524EUCTR2015-003679-31-AT
(EUCTR)
06/04/201611/01/2016New therapeutic strategy in Parkinson’s diseaseConservative iron chelation as a disease-modifying strategy in Parkinson’s disease - FAIRPARK II De Novo Parkinson’s disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Centre Hospitalier Régional et Universitaire de LilleNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
372Phase 2Portugal;France;Czech Republic;Spain;Austria;Netherlands;Germany;United Kingdom
525EUCTR2015-005067-17-CZ
(EUCTR)
01/04/201625/01/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson’s Disease Patients with OFF episodesA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™) Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301 35mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301 50mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
345Phase 3United States;Czech Republic;Canada;Poland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526NCT02719496
(ClinicalTrials.gov)
April 201615/3/2016Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseProve of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseGastrointestinal Disorders in Parkinson's DiseaseDrug: IBEROGASTNantes University HospitalNULLCompleted30 Years80 YearsAll45Phase 2France
527EUCTR2015-004344-19-GB
(EUCTR)
31/03/201616/02/2016An international trial of deferiprone in patients with Parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Deferiprone 600 mg delayed release tablet
INN or Proposed INN: DEFERIPRONE
ApoPharmaNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
528NCT02462603
(ClinicalTrials.gov)
March 31, 201620/5/2015Safety and Biomarker Study of EPI-589 in Parkinson's DiseaseA Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease SubjectsParkinson's DiseaseDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years75 YearsAll44Phase 2United States;Germany;United Kingdom
529JPRN-jRCTs061180060
22/03/201618/03/2019Randomized clinical trial to assess the disease modifying effect of oral inosine for patients with Parkinson's diseaseMulti-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease - Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease Parkinson's disease;D010300Inosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years or placebo (500mg/CP)Nagai MasahiroNULLRecruiting>= 20age oldNot applicableBoth100Phase 2Japan
530EUCTR2015-003679-31-ES
(EUCTR)
21/03/201613/01/2016New therapeutic strategy in Parkinson?s diseaseConservative iron chelation as a disease-modifying strategy in Parkinson?s disease: a multicentre, parallel-group, placebo-controlled, randomized clinical trial of deferiprone - FAIRPARK II De Novo Parkinson?s disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ferriprox 500 mg
Product Name: Deferiprone DR
INN or Proposed INN: DEFERIPRONE
Centre Hospitalier Régional et Universitaire de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
338Phase 3Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531EUCTR2015-004507-23-LV
(EUCTR)
15/03/201613/01/2016Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Finland;Germany;Latvia
532EUCTR2015-005067-17-ES
(EUCTR)
14/03/201617/02/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson?s Disease Patients with OFF episodesA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson?s Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD?) Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301 35mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301 50mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, a wholly owned subsidiary of Acorda Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
345Phase 3United States;Czech Republic;Canada;Poland;Spain
533EUCTR2015-004129-15-ES
(EUCTR)
07/03/201624/02/2016Subjects participating in a Parkinson Disease cohort are offered to undergo a PET imaging scan requiring an intravenous diagnostic drug (florbetaben) with the aim of identifying markers of disease progressionEvaluation of [18F] florbetaben in subjects participating in the Parkinson?s Progression Markers Initiative (PPMI) Protocol Parkinson's Disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neuraceq
Product Name: 18F florbetaben
INN or Proposed INN: FLORBETABEN (18F)
Institute for Neurodegenerative DisordersNULLNot RecruitingFemale: yes
Male: yes
Phase 2Spain
534NCT02687542
(ClinicalTrials.gov)
March 3, 201629/1/2016Efficacy, Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA 15-WEEK, PHASE 2, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED, DOSE RANGING STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson DiseaseDrug: Placebo;Drug: PF-06649751 low dose (1 mg QD);Drug: PF-06649751 middle dose 1 (3 mg QD);Drug: PF-06649751 middle dose 2 (7 mg QD);Drug: PF-06649751 high dose (15 mg QD)PfizerNULLTerminated40 Years85 YearsAll108Phase 2United States;Canada;France;Germany;Japan;Spain
535EUCTR2015-003887-34-CZ
(EUCTR)
02/03/201630/12/2015A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease Moderate to severe Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536NCT02994719
(ClinicalTrials.gov)
March 1, 201621/12/2015Gait Analysis in Neurological DiseaseGait Pattern Analysis in Neurological DiseaseParkinson's Disease;Parkinsonian Disorders;Atypical Parkinson Disease;Progressive Supranuclear Palsy;Multiple System Atrophy;Corticobasal Degeneration;Gait, Frontal;Huntington DiseaseDrug: Anti-Parkinson medication;Device: Deep Brain StimulationBeth Israel Deaconess Medical CenterNULLActive, not recruiting18 Years85 YearsAll120United States
537JPRN-UMIN000021236
2016/03/0101/03/2016Investigation in effect of aroma therapy using magnetoencepharography Normal volunteer, Epilepsy patients, Parkinson disease patientsaroma 1
Trans-nasal administration of lavender essence
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
aroma 2
Trans-nasal administration of grapefruit essence
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
fragrant
Trans-nasal administration of fragrant
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
Osaka University Graduate School of Medicine Department of NeurosurgeryNULLComplete: follow-up continuing20years-old80years-oldMale and Female10Phase 1Japan
538NCT02708186
(ClinicalTrials.gov)
March 201610/3/2016Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)A Phase 2, Double-blind, Randomized, Placebo-controlled Study of Nelotanserin Versus Placebo in Subjects With Dementia With Lewy Bodies (DLB) or Parkinson's Disease Dementia (PDD) Who Have REM Sleep Behavior Disorder (RBD)Dementia With Lewy Bodies;REM Sleep Behavior Disorder;Parkinson's Disease DementiaDrug: Nelotanserin;Drug: PlaceboAxovant Sciences Ltd.NULLCompleted50 YearsN/AAll34Phase 2United States
539NCT02605434
(ClinicalTrials.gov)
March 20165/11/2015A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's PatientsPhase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's PatientsParkinson's DiseaseDrug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- SinemetIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll420Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary
540NCT02668497
(ClinicalTrials.gov)
March 201626/1/2016Kinematic-based BoNT-A Bilateral Upper Limb PD TherapyKinematic Characterization of Upper Limb Parkinson's Disease Tremor for Optimized Botulinum Toxin Type A TherapyParkinson's DiseaseDrug: Botulinum Toxin Type AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll50Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
541NCT02618941
(ClinicalTrials.gov)
February 2, 201625/11/2015Follow-up Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical Activity (AFF008AA)Phase IB Follow-up, Controlled, Parallel Group, Single-center Study to Assess a Second Boost Immunization With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological and Clinical Activity in Patients Who Have Participated in the AFF008 ProgramParkinson's DiseaseBiological: AFFITOPE® PD01AAffiris AGNULLCompleted40 Years68 YearsAll26Phase 1Austria
542NCT04569656
(ClinicalTrials.gov)
February 2, 201624/9/2020Treatment of Chronic Constipation in Parkinson's DiseasePilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinson's DiseaseParkinson DiseaseDrug: hydrolyzed guar gumIRCCS San RaffaeleNULLCompleted18 YearsN/AAll34Phase 2Italy
543JPRN-UMIN000020527
2016/02/0101/02/2016Multi-centered, placebo-controlled, double-blind, randomized clinical trial to assess the effect of oral inosine on the onset of wearing off in patients with early stage Parkinson's disease Parkinson's diseaseInosine to maintain a serum urate level between 6.0-7.5 mg/dL for 2 years
Lactose as a placebo for 2 years
Ehime University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female100Phase 2Japan
544JPRN-UMIN000020288
2016/02/0128/12/2015Intervention Study of Istradefylline for the Treatment of Gait Disorders in Patients with Parkinson's Disease. Parkinson's diseaseIn this research, the duration of evaluation will be 12 weeks.
Treatment with istradefylline will be started at a dose of 20 mg administered once daily. The dose of istradefylline will be increased to 40 mg once daily if the patient has no tolerability issues and still has motor symptoms at Week 4. After the Week 4, the dose will be allowed to be reduced to 20 mg once daily, if the patient exhibits any tolerability issues such as the occurrence of adverse drug reactions caused by istradefylline.
Juntendo University Shizuoka HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
545NCT02641054
(ClinicalTrials.gov)
February 20167/12/2015Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's DiseaseDouble-Blind Randomized Placebo-Controlled Cross-Over Phase IIa Trial to Evaluate Efficacy of CVXL-0107 on Parkinson-Related Symptoms and Levodopa-Induced Dyskinesia in Advanced Parkinson's Disease Patients Using a Levodopa Challenge TestIdiopathic Parkinson DiseaseDrug: CVXL-0107;Drug: Placebo;Drug: LevodopaCleveXel PharmaNULLCompleted40 Years75 YearsAll21Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546EUCTR2015-004238-85-ES
(EUCTR)
27/01/201610/12/2015Brain SPECT in premotor stage of Parkinson diseaseIctal brain SPECT in the premotor stage of Parkinson disease Parkinson disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CERETEC (TM) Estabilizado
Product Name: Ceretec
INN or Proposed INN: Ceretec
Other descriptive name: TECHNETIUM (99MTC) EXAMETAZIME
IDIBAPSNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Spain
547JPRN-JapicCTI-153112
22/1/201625/12/2015ONO-2370 Phase 2 study(ONO-2370-02)ONO-2370 a Phase 2 Double-Blind, Randomised, Placebo-Controlled, Parallel-Group study, and an Open-Label, Uncontrolled, Multicenter, Long-term, Extension study(ONO-2370-02) Parkinson's diseaseIntervention name : ONO-2370
INN of the intervention : Opicapone
Dosage And administration of the intervention : ONO-2370 once-daily
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Once-daily placebo equivalent to active control
ONO PHARMACEUTICAL CO.,LTD.NULLcomplete3083BOTH399Phase 2Japan
548EUCTR2015-001786-10-GB
(EUCTR)
18/01/201623/11/2015A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: EPI-589
Product Code: EPI-589
Other descriptive name: (R)-troloxamide quinone
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Germany;United Kingdom
549NCT03258294
(ClinicalTrials.gov)
January 13, 201620/8/2017Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's DiseaseEffect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled TrialParkinson's DiseaseDrug: Melatonin(Circadin®);Drug: Placebo Oral TabletKIMJisunKuhnil Pharmaceutical Co., Ltd.Enrolling by invitation55 YearsN/AAll82Phase 4NULL
550ChiCTR-CPC-15007223
2016-01-012015-09-22Characteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons DiseaseCharacteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons Disease Parkinsons Disease; Sleep DisorderThe treatment group; The control group:Rotigotine patch;Department of Neurology, Changzheng Hospital, Second Military Medical UniversityNULLPendingBothThe treatment group; The control group:100;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551NCT02639221
(ClinicalTrials.gov)
January 201617/12/2015A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female SubjectsPXT002331 A Phase I, Double Blind, Placebo Controlled, First in Human, Single and Multiple Ascending Oral Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male and Female SubjectsParkinson's DiseaseDrug: PXT002331Prexton TherapeuticsNULLCompleted18 Years60 YearsBoth64Phase 1United Kingdom
552NCT02549573
(ClinicalTrials.gov)
January 20169/9/2015Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®Outpatient Physical Therapy Intervention in Subjects With Parkinson's DiseaseCurrently Using APOKYN®: A Phase IV Study of Outcome Assessments of Physical Therapy in Subjects in an On Versus End-of-Dose-Off Motor StateParkinson's Disease;Motor SymptomsDrug: APOKYN;Behavioral: Physical TherapyUS WorldMeds LLCNULLTerminated18 Years78 YearsAll13Phase 4United States
553NCT02579473
(ClinicalTrials.gov)
January 201613/10/2015A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose TitrationParkinson's DiseaseDrug: SER-214Serina TherapeuticsNULLActive, not recruiting40 Years80 YearsAll20Phase 1United States
554NCT02768077
(ClinicalTrials.gov)
January 20169/5/2016Effect of Melatonin on Sleep Disturbances in Patients With Parkinson's DiseaseEffect of Melatonin on Sleep Disturbances in Patients With Parkinson's Disease: Double Blind, Randomized, Placebo Controlled TrialParkinson's DiseaseDrug: Melatonin(Circadin®);Drug: PlaceboKuhnil Pharmaceutical Co., Ltd.NULLEnrolling by invitation55 YearsN/ABoth100Phase 4NULL
555NCT02649608
(ClinicalTrials.gov)
January 20166/1/2016An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease PatientsInterventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's DiseaseParkinson DiseaseDrug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621;Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621H. Lundbeck A/SNULLCompleted45 Years75 YearsAll15Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556EUCTR2014-002600-24-AT
(EUCTR)
30/12/201525/09/2015Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complicationsA TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST Idiopathic Parkinson's Disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE
Zambon S.P.A.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
557JPRN-JapicCTI-153057
14/12/201502/11/2015ME2125 Phase III (ME2125-4)A Phase III, Long-Term Treatment Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon Parkinson's diseaseIntervention name : ME2125 (safinamide mesilate)
INN of the intervention : safinamide
Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.
Meiji Seika Pharma Co., Ltd.NULLcomplete30BOTH200Phase 3Japan
558EUCTR2014-005630-60-ES
(EUCTR)
11/12/201505/10/2015A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson´s DiseaseExperiencing End-of-Dose Wearing-Off (TOZ-PD) - TOZ-PD Parkinson´s Disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tozadenant
Product Code: SYN115
INN or Proposed INN: Tozadenant
Other descriptive name: TOZADENANT
Biotie Therapies Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Germany
559EUCTR2014-002600-24-IT
(EUCTR)
11/12/201516/02/2018Safinamide versus placebo in patients with Parkinson's disease for improvement of motor complicationsA TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST Idiopathic Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xadago
Product Name: Safinamide
Product Code: na
INN or Proposed INN: SAFINAMIDE METANSOLFONATO
Other descriptive name: SAFINAMIDE METANSOLFONATO
Trade Name: Xadago
INN or Proposed INN: SAFINAMIDE METANSOLFONATO
Other descriptive name: SAFINAMIDE METANSOLFONATO
ZAMBON SPANULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;United Kingdom;Switzerland;Italy;Sweden
560EUCTR2014-002600-24-SE
(EUCTR)
03/12/201530/07/2015Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complicationsA TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST Idiopathic Parkinson's Disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: SAFINAMIDE
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: SAFINAMIDE
Other descriptive name: SAFINAMIDE
Zambon S.P.A.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
561NCT02616120
(ClinicalTrials.gov)
December 201520/11/2015Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's DiseaseEfficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease PatientsParkinson's DiseaseDrug: SQJZ herbal mixtures;Drug: PlaceboDongzhimen Hospital, BeijingNULLRecruiting18 Years80 YearsAll240Phase 2China
562NCT02536976
(ClinicalTrials.gov)
December 201528/8/2015Mirabegron in Parkinson Disease and Impaired CognitionA Clinical Trial of Mirabegron for Overactive Bladder Symptoms in Patients With Parkinson Disease and Impaired CognitionParkinson Disease;Overactive Bladder;Impaired CognitionDrug: mirabegron;Drug: PlaceboHealthPartners InstituteNULLCompleted25 Years80 YearsAll7Phase 4United States
563NCT02470780
(ClinicalTrials.gov)
December 20154/6/2015Treating Bacterial Overgrowth in Parkinson's DiseaseTreating Bacterial Overgrowth in Parkinson's DiseaseParkinson's Disease;Small Intestinal Bacterial OvergrowthDrug: Rifaximin;Drug: PlaceboUniversity of CincinnatiNULLCompleted18 YearsN/AAll24Phase 2;Phase 3United States
564JPRN-JapicCTI-153056
24/11/201502/11/2015ME2125 Phase II/III (ME2125-3)A Phase II/III, Double-Blind, Placebo-Controlled Study of ME2125 in Patients with Parkinson's Disease with Wearing-Off Phenomenon Parkinson's diseaseIntervention name : ME2125 (safinamide mesilate)
INN of the intervention : safinamide
Dosage And administration of the intervention : Orally administer a dose of 2 tablets once a daily in morning.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Orally administer a dose of 2 tablets once a daily in morning.
Meiji Seika Pharma Co., Ltd.NULLcomplete30BOTH410Phase 2;Phase 3Japan
565EUCTR2014-002600-24-ES
(EUCTR)
19/11/201505/10/2015Safinamide versus placebo in patients with Parkinson?s disease for improvement of motor complicationsA TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON?S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST Idiopathic Parkinson's Disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: safinamide
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
INN or Proposed INN: safinamide
Other descriptive name: SAFINAMIDE
Zambon S.P.A.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Italy;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
566EUCTR2015-002631-17-ES
(EUCTR)
19/11/201503/11/2015A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patientsAn intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Institut de Recerca del Hospital de la Santa Creu i Sant PauNULLNot Recruiting Female: yes
Male: yes
18Phase 4Spain
567NCT02565628
(ClinicalTrials.gov)
November 16, 201528/9/2015PF-06669571 In Subjects With Idiopathic Parkinson's DiseaseA Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.Idiopathic Parkinson's DiseaseDrug: PF-06669571;Drug: PlaceboPfizerNULLCompletedN/AN/AAll20Phase 1United States
568JPRN-UMIN000019676
2015/11/1010/11/2015The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's diseaseThe double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease - The double blind, placebo controlled trial of modafinil for excessive daytime sleepiness in Parkinson's disease Parkinson's diseasetaking modafinil (200 mg/day) after breakfast for 4 weeks, wash out for 2 weeks, taking matching placebo after breakfast for 4 weeks
taking matching placebo after breakfast for 4 weeks, wash out for 2 weeks, taking modafinil (200 mg/day) after breakfast for 4 weeks
Department of Neurology and Clinical Pharmacology, Ehime University Graduate School of MedicineNULLComplete: follow-up complete20years-old100years-oldMale and Female20Not selectedJapan
569EUCTR2015-000148-40-GB
(EUCTR)
09/11/201516/09/2015A trial comparing simvastatin to placebo as a neuronal protective treatment for Parkinson's disease.Simvastatin as a neuroprotective treatment for Parkinson's disease: a double-blind, randomised, placebo controlled futility study in patients of moderate severity. - Simvastatin as a neuroprotective treatment for moderate PD (PD STAT) Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Simvastatin
INN or Proposed INN: Simvastatin
Plymouth Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
198Phase 3United Kingdom
570JPRN-UMIN000019654
2015/11/0606/11/2015The effect of rich-hydrogen water drinking to gut peptide Parkinson's disease, healthy controlhydrogen water
natural water
Nagoya graduate school of medicine universityNULLPending20years-old80years-oldMale and Female40Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
571JPRN-jRCTs041180070
04/11/201507/03/2019Trerief Impact in PD PET StudyRandomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS Parkinson's disease
Parkinson's disease;D010300
[1] Zonisamide treatment group
Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
[2] Zonisamide non-treatment group
Only levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Ouchi YasuomiNULLNot RecruitingNot applicable< 80age oldBoth20N/AJapan
572JPRN-UMIN000019090
2015/11/0401/11/2015Reduced form of CoenzymeQ10 for Parkinson's disease - open trial of dose finding test and combination with hydrogen water Parkinson's diseasereduced form of CoQ10 300mg 16weeks
reduced form of CoQ10 600mg 16weeks
reduced form of CoQ10 600mg 16weeks
hydrogen water 500ml(Suisosui 7.0) 16weeks
Juntendo University Koshigaya HospitalNULLComplete: follow-up complete20years-old80years-oldMale and Female45Not selectedJapan
573EUCTR2014-002600-24-GB
(EUCTR)
03/11/201528/07/2015Safinamide versus placebo in patients with Parkinson’s disease for improvement of motor complicationsA TWO YEAR, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE LONG TERM EFFICACY AND SAFETY OF SAFINAMIDE 100 MG, ONCE DAILY, AS ADD ON THERAPY, IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS - EVEREST Idiopathic Parkinson's Disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE
Trade Name: Xadago
Product Name: safinamide
Other descriptive name: SAFINAMIDE
Zambon S.P.A.NULLNot RecruitingFemale: yes
Male: yes
556Phase 3France;Spain;Austria;Russian Federation;Germany;Switzerland;Italy;United Kingdom;Sweden
574NCT02271503
(ClinicalTrials.gov)
November 201513/10/2014A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's DiseaseA Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mgImpax Laboratories, LLCNULLCompleted40 YearsN/AAll26Phase 2United States
575NCT02577523
(ClinicalTrials.gov)
November 20156/10/2015A Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of ND0612H, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseA Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612 (Levodopa/Carbidopa solution)NeuroDerm Ltd.NULLCompleted30 Years80 YearsAll38Phase 2United States;Austria;Israel;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
576EUCTR2014-005630-60-DE
(EUCTR)
29/10/201507/07/2015A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tozadenant
Product Code: SYN115
INN or Proposed INN: Tozadenant
Other descriptive name: TOZADENANT
Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
577EUCTR2015-003045-26-SE
(EUCTR)
23/10/201515/09/2015Study of Dopamine Transporters (signal substance in central nervous system)in patients with early signs of Parkinson´s disease.[18F] FE-PE2I PET/CT study of Dopamine Transporters in Early Parkinsonian disease. Patients with newly clinically diagnosed untreated idiopathic parkinsonism
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: [18F]FE-PE2I
INN or Proposed INN: [18F]-(E)-N-(3-iodoprop-2-enyl)-2b-carbofluoroethoxy-3b-(4'-methylphenyl)nortropane
Trade Name: DaTSCAN
INN or Proposed INN: IOFLUPANE (123I)
Product Name: 15O H2O
INN or Proposed INN: [15O]H2O
Umeå University HospitalNULLNot RecruitingFemale: yes
Male: yes
105Phase 2Sweden
578JPRN-UMIN000019082
2015/10/1022/09/2015the effect of smell dysfunction using hydrogen gas for parkinson disease parkinson's diseasewe measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after room air.
we measured smell test and urine 8-OHdG before and after room air. After two month discontinuation of administration. we measured smell test and urine 8-OHdG before and after 3.5% hydrogen gas.
Nagoya University Graduate School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female20Not selectedJapan
579NCT02933372
(ClinicalTrials.gov)
October 5, 20156/4/2016Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiments 1 & 2 - Proj #3Cholinergic Mechanisms of Gait Dysfunction in Parkinson's Disease Experiments 1 & 2 - Projects #3Parkinson's DiseaseDrug: Varenicline;Radiation: [18-Fluorine] Flubatine PET Scan;Other: Evaluation by InvestigatorUniversity of MichiganNULLCompleted45 YearsN/AAll25Phase 2NULL
580JPRN-UMIN000019524
2015/10/0128/10/2015Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) imagesRandomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) Parkinson's DiseaseZonisamide treatment group:

Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
Zonisamide non-treatment group:

Only Levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Hamamatsu University School of MedicineNULLComplete: follow-up completeNot applicable80years-oldMale and Female20Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581NCT02562768
(ClinicalTrials.gov)
September 30, 201528/9/2015A Study of LY3154207 in Healthy Participants and Participants With Parkinson's DiseaseMultiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted20 YearsN/AAll80Phase 1United States
582EUCTR2014-005630-60-CZ
(EUCTR)
23/09/201510/07/2015A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tozadenant
Product Code: SYN115
INN or Proposed INN: Tozadenant
Other descriptive name: TOZADENANT
Biotie Therapies Inc. (a wholly owned subsidiary of Acorda Therapeutics Inc.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
583EUCTR2014-004865-26-IT
(EUCTR)
21/09/201529/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88European Union;Canada;Spain;Australia;Germany;Italy;Sweden
584NCT02549092
(ClinicalTrials.gov)
September 9, 201511/9/2015A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS StudyAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLActive, not recruiting30 Years99 YearsAll89Phase 3United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
585NCT02542696
(ClinicalTrials.gov)
August 31, 20153/9/2015Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseAn Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277SunovionNULLRecruiting18 YearsN/AAll226Phase 3United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586EUCTR2014-004865-26-DE
(EUCTR)
27/08/201522/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3European Union;Canada;Spain;Australia;Germany;Italy;Sweden
587EUCTR2015-000373-13-DE
(EUCTR)
18/08/201518/05/2015A study to examine the effectiveness and safety of a new drug for involuntary muscle movements in patients with Parkinson’s diseasePhase 2, multicenter, randomized, double-blind, placebo-controlled, four-period cross-over, dose-range finding study to evaluate the safety, tolerability and efficacy of Eltoprazine in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease. Parkinson’s disease levodopa induced dyskinesia (PD-LID)
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Eltoprazine Hydrochloride
INN or Proposed INN: ELTOPRAZINE
Product Name: Eltoprazine Hydrochloride
INN or Proposed INN: ELTOPRAZINE
Product Name: Eltoprazine Hydrochloride
INN or Proposed INN: ELTOPRAZINE
Amarantus BioScience Holdings, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Germany;Sweden
588EUCTR2014-004865-26-SE
(EUCTR)
05/08/201525/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
589NCT02599753
(ClinicalTrials.gov)
August 20151/11/2015Investigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease PatientsInvestigating the Microstructural and Functional Alterations of Brain in Parkinson's Disease Patients With Neuropsychiatric Disorders by Multimodal NeuroimagingParkinson's DiseaseDrug: 18-FDTBZChang Gung Memorial HospitalNULLCompleted20 Years80 YearsAll35Phase 2Taiwan
590NCT02554734
(ClinicalTrials.gov)
August 201510/6/2015Pharmacokinetic Study in Healthy VolunteersPharmacokinetics of Levodopa After Repeated Doses of Carbidopa, ODM-104 and Levodopa: an Open, Randomised Study With Crossover Design in Healthy Males and FemalesParkinson's DiseaseDrug: levodopa, carbidopa, ODM-104;Drug: levodopa, carbidopa, entacaponeOrion Corporation, Orion PharmaNULLCompleted18 Years65 YearsBoth15Phase 1Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591NCT02917122
(ClinicalTrials.gov)
August 201530/6/2016The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's DiseaseThe Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's DiseaseParkinson Disease;DepressionDevice: active tDCS;Drug: Sertraline;Device: sham tDCSNational Cheng-Kung University HospitalNULLActive, not recruiting18 Years75 YearsBoth40Phase 1;Phase 2NULL
592NCT02337751
(ClinicalTrials.gov)
July 10, 20159/1/2015A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With LevodopaParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll198Phase 3Japan
593NCT02459886
(ClinicalTrials.gov)
July 1, 201529/5/2015Single-Ascending Dose Study of BIIB054 in Healthy Participants and Early Parkinson's DiseaseA Phase 1 Randomized, Double-Blinded, Placebo-Controlled Single-Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB054 in Healthy Subjects and Subjects With Early Parkinson's DiseaseParkinson's Disease;HealthyDrug: BIIB054;Drug: PlaceboBiogenNULLCompleted40 Years80 YearsAll66Phase 1United States
594NCT02488265
(ClinicalTrials.gov)
July 1, 201521/5/2015Protocol: Balance Training in Parkinson's DiseaseRandomized Controlled Trial Protocol: Balance Training With Rhythmical Cues to Improve and Maintain Balance Control in Parkinson's DiseaseParkinson DiseaseOther: Balance Training;Other: Screening to prevent fallsUniversity of Sao Paulo General HospitalNULLCompleted50 Years70 YearsAll150N/ABrazil
595NCT02415062
(ClinicalTrials.gov)
July 201514/3/2015The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With DementiaThe Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With DementiaParkinson's DiseaseDrug: DonepezilInje UniversityNULLRecruiting50 Years80 YearsBoth150Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596NCT02453386
(ClinicalTrials.gov)
July 201521/5/2015Safety and Efficacy Study of Tozadenant to Treat End of Dose Wearing Off in Parkinson's PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-Off (TOZ-PD)Idiopathic Parkinson's DiseaseDrug: tozadenant;Drug: placeboBiotie Therapies Inc.NULLTerminated30 Years80 YearsAll449Phase 3United States;Austria;Canada;Czechia;Germany;Italy;Spain;Czech Republic
597EUCTR2014-003738-24-AT
(EUCTR)
26/06/201501/04/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 17.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3Germany;Spain;Austria;United States
598EUCTR2014-000657-36-NL
(EUCTR)
22/06/201503/06/2015Trial to investigate the efficacy of treatments in apomorphine-induced skin reactionsOpen-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]University Medical Center GroningenNULLNot Recruiting Female: yes
Male: yes
20Phase 2Netherlands
599EUCTR2014-003739-20-AT
(EUCTR)
19/06/201501/04/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Spain;Austria;Germany
600EUCTR2014-004865-26-ES
(EUCTR)
19/06/201515/06/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
88Phase 3European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601NCT02469090
(ClinicalTrials.gov)
June 18, 20159/6/2015Efficacy, Safety and Tolerability Study of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseRandomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy, Safety and Tolerability of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson Disease, Off EpisodesDrug: APL-130277;Drug: PlaceboSunovionNULLCompleted18 YearsN/AAll141Phase 3United States;Canada;United Kingdom
602NCT02230930
(ClinicalTrials.gov)
June 201529/8/2014Treatment of Apomorphine-induced Skin Reactions: a Pilot StudyOpen-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin ReactionsParkinson's Disease;Apomorphine-induced Skin ReactionsDrug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mgUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll20Phase 2Netherlands
603NCT02450786
(ClinicalTrials.gov)
June 201514/5/2015Effect of Donepezil on Cognition in Parkinson's Disease With Mild Cognitive Impairment (PD-MCI)Parkinson's DiseaseDrug: DonepezilYonsei UniversityNULLActive, not recruiting40 YearsN/AAll80Phase 2Korea, Republic of
604EUCTR2014-005422-35-GB
(EUCTR)
28/05/201502/04/2015The role of Buspirone in attenuating involuntary movements (Dyskinesias) in patients with Parkinson's disease. THE ROLE OF BUSPIRONE IN ATTENUATING LEVODOPA-INDUCED DYSKINESIAS IN PATIENTS WITH PARKINSON'S DISEASE: A CLINICAL AND POSITRON EMISSION TOMOGRAPHY STUDY WITH 11C-PHNO. - The role of buspirone in LIDs in patients with Parkinson’s disease. Levodopa induced dyskinesias within Parkinson's disease.
MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Imperial College London-Imperial College Healthcare NHS TrustNULLNot Recruiting Female: yes
Male: yes
24Phase 4United Kingdom
605JPRN-jRCTs061180028
11/05/201526/02/2019Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetineA double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine Parkinson's disease;D010300The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.Ando RinaNULLComplete20 years oldNoneBoth50Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606EUCTR2014-003799-22-AT
(EUCTR)
08/05/201512/01/2015A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s diseaseA Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
408Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
607EUCTR2010-024424-26-SK
(EUCTR)
05/05/201528/04/2015Clinical study for the evaluation of the safety and efficacy of masitinib in patients suffering from parkinson's diseaseA prospective, multicenter, randomised, double-blind, placebo-controlled, parallel group, phase 2 study to compare the efficacy and safety of masitinib versus placebo on cognitive impairment associated with Parkinson's disease Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AB ScienceNULLNot Recruiting Female: yes
Male: yes
45Phase 2France;United States;Hungary;Czech Republic;Slovakia;Spain;Romania;Bulgaria;South Africa;Germany
608NCT02439125
(ClinicalTrials.gov)
May 201513/4/2015A Study of Efficacy and Safety of Eltoprazine HCl for Treating Levodopa-induced Dyskinesia in Parkinson's Disease PatientsPhase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, 4-way Crossover, Dose-finding Study, of Eltoprazine Safety, Tolerability and Efficacy in the Treatment of Levodopa-induced Dyskinesia in Patients With Parkinson's DiseaseParkinson's Disease;DyskinesiaDrug: Eltoprazine HCl;Drug: PlaceboAmarantus BioScience Holdings, Inc.NULLActive, not recruiting30 Years85 YearsBoth60Phase 2United States
609NCT02452125
(ClinicalTrials.gov)
May 201520/5/2015The Effects of Nicotine Chewing Gum in Parkinson's DiseaseThe Effects of Nicotine Chewing Gum on Acute Low Blood Pressure in Parkinson's DiseaseLow Blood Pressure;Parkinsons DiseaseDietary Supplement: Nicotine gumNew York Institute of TechnologyNULLCompletedN/AN/AAll10N/AUnited States
610EUCTR2014-003738-24-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611EUCTR2014-003739-20-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Adamas Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
250Phase 3France;United States;Spain;Austria;Germany
612EUCTR2014-003799-22-DE
(EUCTR)
22/04/201504/12/2014A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s diseaseA Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
408Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
613EUCTR2014-002697-37-GB
(EUCTR)
15/04/201519/03/2015Study of Melatonin for treatment of Nocturia in PDSingle-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease - Study of Melatonin for treatment of Nocturia in PD Parkinson's DiseaseNocturia
MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Circadin®
Product Name: Melatonin
Product Code: AS2
INN or Proposed INN: Melatonin
University College LondonNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United Kingdom
614JPRN-JapicCTI-152870
11/4/201514/04/2015A parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPAA phase III parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA Parkinson's diseaseIntervention name : HP-3000 (ropinirole hydrochloride patch)
Dosage And administration of the intervention : Transdermal, once daily
Control intervention name : HP-3000 placebo
Dosage And administration of the control intervention : Transdermal, once daily
Control intervention name : Ropinirole hydrochloride extended-release tablet
Dosage And administration of the control intervention : Oral, once daily
Control intervention name : Ropinirole hydrochloride extended-release tablet placebo
Dosage And administration of the control intervention : Oral, once daily
Hisamitsu Pharmaceutical Co.,Inc.NULL2079BOTHPhase 3NULL
615EUCTR2014-003739-20-FR
(EUCTR)
10/04/201519/06/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Adamas Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
200Phase 3United States;France;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
616JPRN-UMIN000017036
2015/04/0303/04/2015Association of ghrelin and leptin in cardiovascular autonomic dysfunction in patients with primary dysautonomia. autonomic failure such as Parkinson's diseaseblood test of Leptin and Ghrelin
blood test of Leptin and Ghrelin
Nagoya University Graduate School of MedicineNULLComplete: follow-up complete40years-oldNot applicableMale and Female50Not applicableJapan
617JPRN-UMIN000016591
2015/04/0120/02/2015Clinical trial of balance exercise "Assist" Stroke, Parkinson disease, Osteoarthrosisuse of balance exercise assist
ordinary balance exercise
Juntendo UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female40Not applicableJapan
618JPRN-UMIN000016734
2015/04/0101/04/2015The evaluation of duloxetine effect for the parkinsonism and gait freezing Parkinson's diseaseDrug ; Duloxetine
Duraion; SEP012014-AUG312016
Doseage; 20mg/day or 40mg/day
Times; one time per day P.O.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-old85years-oldMale and Female30Not selectedJapan
619NCT02359448
(ClinicalTrials.gov)
April 20154/2/2015Melatonin for Nocturia in Parkinson's DiseaseSingle-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's DiseaseParkinson's Disease;NocturiaDrug: MelatoninUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth20Phase 2United Kingdom
620NCT02486432
(ClinicalTrials.gov)
April 201522/6/2015A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa) Doses Administered Using a Divided Dose ApproachParkinson's DiseaseDrug: Levodopa/Carbidopa (Sinemet)NeuroDerm Ltd.Quotient ClinicalCompleted40 Years65 YearsBoth6Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621EUCTR2014-003738-24-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
622EUCTR2014-003739-20-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Spain;Austria;Germany
623ChiCTR-DOD-15006097
2015-03-182015-03-16The diagnostic value of olfactory-evoked potentials in Parkinson'sdiseaseThe diagnostic value of olfactory-evoked potentials in Parkinson'sdisease Parkinson's diseaseGold Standard:;Index test:;Guangdong General Hospital, Guangdong Academy of Medical SciencesNULLRecruiting5080BothTarget condition:0;Difficult condition:0China
624EUCTR2014-003799-22-BE
(EUCTR)
16/03/201516/12/2014A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s diseaseA Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
365Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
625JPRN-UMIN000016664
2015/03/0101/03/2015Effect of nicotine patch in Cognitive function improvement in Parkinson's disease Parkinson's diseasenicotine patchDepartment of Clinical Pharmacology and Neurology Ehime University graduated School of MedicineNULLRecruitingNot applicableNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626NCT02373072
(ClinicalTrials.gov)
March 201520/2/2015A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 in Subjects With Idiopathic Parkinson's DiseaseA Phase 1, Double Blind, Sponsor Open, Randomized, Placebo-controlled, Single Ascending Dose Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: PF-06649751;Drug: Trimethobenzamide Hydrochloride;Drug: PlaceboPfizerNULLCompletedN/AN/AAll18Phase 1United States;Belgium
627NCT02066571
(ClinicalTrials.gov)
March 201518/2/2014Study to Assess the Clinical Benefit and Safety of Droxidopa in Parkinson's DiseaseA Phase II, Double-Blind, Placebo-Controlled, Crossover Study to Assess Clinical Benefit and Safety of Droxidopa in the Treatment of Parkinson's DiseaseParkinson's Disease;Freezing of Gait;Cognitive Ability, GeneralDrug: Droxidopa;Drug: sugar pillHenry Ford Health SystemNULLEnrolling by invitation30 YearsN/ABoth20Phase 2United States
628NCT02352363
(ClinicalTrials.gov)
March 201526/1/2015Randomized Safety Study of CVT-301 Compared to an Observational Control GroupA Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease (PD) Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort ControlIdiopathic Parkinson's DiseaseDrug: CVT-301;Other: Observational cohortAcorda TherapeuticsNULLCompleted30 Years85 YearsAll408Phase 3United States;Austria;Belgium;Czechia;France;Germany;Hungary;Israel;Netherlands;Poland;Romania;Serbia;Spain;United Kingdom;Czech Republic;Italy
629NCT02393027
(ClinicalTrials.gov)
March 20156/3/2015Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999Quantification of Dopamine Active Transporter (DAT) in Humans: Validation of a New Radiophamaceutical, the [18F] LBT-999Idiopathic Parkinson DiseaseDrug: [18F] LBT-999 PETUniversity Hospital, ToursNULLTerminated45 Years75 YearsAll16Early Phase 1France
630NCT02452606
(ClinicalTrials.gov)
March 201514/5/2015Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's DiseaseClock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's DiseaseParkinson Disease;Sleep DisordersDrug: Stalevo®Asan Medical CenterNULLRecruiting20 Years79 YearsBoth100N/AKorea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
631NCT02242487
(ClinicalTrials.gov)
March 201515/9/2014Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)Idiopathic Parkinson's DiseaseDrug: CVT-301Acorda TherapeuticsNULLCompleted30 Years86 YearsAll325Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
632EUCTR2014-003799-22-CZ
(EUCTR)
26/02/201526/11/2014A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s diseaseA Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
408Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
633JPRN-UMIN000016485
2015/02/2509/02/2015Pilot study about imaging method of 18F-fluoro-dopa and 11C-raclopride in Parkinson's disease and Parkinson's syndrome Healthy subjects, Parkinson's disease patients and Parkinson's syndrome patientsIntravenous injection of 18F-fluoro-dopa and 11C-raclopride
PET imaging
Institute of Biomedical Research and InnovationNULLComplete: follow-up complete35years-oldNot applicableMale and Female20Not selectedJapan
634EUCTR2014-003799-22-HU
(EUCTR)
11/02/201520/11/2014A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s diseaseA Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson’s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
365Phase 3Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Romania;Germany
635NCT02337725
(ClinicalTrials.gov)
February 7, 20159/1/2015A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With LevodopaParkinson's DiseaseDrug: TVP-1012;Drug: PlaceboTakedaNULLCompleted30 Years80 YearsAll244Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636NCT02337764
(ClinicalTrials.gov)
February 3, 20159/1/2015A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease PatientsParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll222Phase 3Japan
637EUCTR2014-003799-22-ES
(EUCTR)
02/02/201516/12/2014A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson?s diseaseA Phase 3, Randomized Study Investigating the Safety ofCVT-301 (Levodopa Inhalation Powder) in Parkinson?s DiseasePatients With Motor Response Fluctuations (OFF Phenomena)Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
365Phase 3Serbia;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
638NCT02339064
(ClinicalTrials.gov)
February 201531/3/2014Infusion of Apomorphine: Long-term Safety StudyA Phase 3, Open-Label Study of the Safety, Efficacy and Tolerability of Apomorphine Administered by Continuous Subcutaneous Infusion in Advanced Parkinson's Disease Patients With Unsatisfactory Control on Available TherapyIdiopathic Parkinson's DiseaseDrug: apomorphine infusionUS WorldMeds LLCNULLActive, not recruiting30 YearsN/AAll99Phase 3United States
639NCT02409823
(ClinicalTrials.gov)
February 20151/4/2015Clinical Registry of Patients Under Treatment With Atypical AntipsychoticsClinical Registry of Patients Under Treatment With Atypical AntipsychoticsSchizophrenia;Major Depressive Disorder;Bipolar Depressive Disorder;Parkinson's Disease With HallucinationsDrug: Atypical AntipsychoticsPontifical Catholic University of ArgentinaNULLCompleted18 YearsN/ABoth665N/ANULL
640JPRN-JapicCTI-152762
27/1/2015A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease PatientsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients Parkinson's diseaseIntervention name : TVP-1012 (1 mg/day) with levodopa
Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period.
Control intervention name : null
TAKEDA PHARMACEUTICAL COMPANY LTD.NULL3079BOTH215Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641NCT02337738
(ClinicalTrials.gov)
January 27, 20159/1/2015A Phase 2/3 Study of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2/3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 0.5 mg or 1 mg in Levodopa Treated Parkinson's Disease Patients With Wearing OffParkinson's DiseaseDrug: TVP-1012 1mg;Drug: TVP-1012 0.5mg;Drug: PlaceboTakedaNULLCompleted30 Years79 YearsAll404Phase 2;Phase 3Japan
642EUCTR2014-003799-22-GB
(EUCTR)
15/01/201521/11/2014A study of the safety and drug effects of levodopa inhalation powder (CVT-301) compared to Standard of Care Observational Cohort in patients with Parkinson’s disease A Phase 3, Randomized Study Investigating the Safety of CVT-301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Compared to an Observational Cohort Control Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 18.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Civitas Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
365Phase 3Serbia;United States;Spain;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Romania;Germany
643NCT02406105
(ClinicalTrials.gov)
January 201522/2/2015An Effectiveness and Toxicity of CyberKnife Based Radiosurgery for Parkinson DiseaseAn Evaluation of Effectiveness and Toxicity of CyberKnife Based Functional Radiosurgery for Parkinson Disease Patients Suffering From Tremor and Its Implementation in PolandParkinson DiseaseRadiation: Radiosurgical thalamotomy;Drug: CyberKnifeMaria Sklodowska-Curie Memorial Cancer Center, Institute of OncologyNULLRecruiting18 YearsN/ABoth27Phase 2Poland
644EUCTR2014-004501-32-NL
(EUCTR)
11/12/201403/12/2014Treatment in Advanced Parkinson's disease: a cost-effectiveness analysis of two different treatmentsInfusion VErsus STimulation, a cost-effectiveness analysis of the treatment in advanced Parkinson's diseasecomparing Continuous Intrajejunal Levodopa Infusion to the traditional standard treetment Deep BrainStimulation; - INVEST (INfusion VErsus STimulation) Patients with advanced PD who's motor symptoms — severe responsefluctuations, dyskinesias, painful dystonia and / or bradykinesia —cannot be controlled despite optimal oral pharmacological therapy.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Duodopa, levodopa 20 mg/ml + carbidopa 5 mg/ml, intestinal gelAcademic Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
645JPRN-JapicCTI-142748
11/12/201416/12/2014Long-term study of HP-3000 in patients with Parkinson's diseaseA phase III long-term study of HP-3000 in patients with Parkinson's disease Parkinson's diseaseIntervention name : HP-3000(ropinirole hydrochloride patch)
Dosage And administration of the intervention : Transdermal, once daily
Hisamitsu Pharmaceutical Co.,Inc.NULL2079BOTHPhase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
646NCT03116308
(ClinicalTrials.gov)
November 21, 201412/4/2017Effect of Food on OpicaponeEffect of Food on Opicapone Bioavailability and Pharmacodynamics in Healthy SubjectsParkinson DiseaseDrug: Opicapone (OPC)Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
647EUCTR2014-001132-10-FR
(EUCTR)
18/11/201418/06/2015A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson’s Disease Patients with Abnormal Involuntary Movements caused by LevodopaA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162United States;France;Canada;Spain;Germany
648ChiCTR-DDD-17010794
2014-11-082017-03-05The study on early diagnosis of Parkinson 's disease by transcranial ultrasonographythe study on early diagnosis of Parkinson 's disease by transcranial ultrasonography Parkinson's DiseaseGold Standard:Diagnosis of Parkinson disease needs to meet 3 or more: unilateral onset;resting tremor;progressive course; long term asymmetry, the most obvious symptoms is the onset side; a good response to levodopa (70% ~ 100%); levodopa induced chorea; a reaction of levodopa lasts 5 years or more; clinical course last;Index test:Laboratory apparatus
As shown in Figure 1, The ultrasound equipment, Philips IE33-BOMJH1 color Doppler ultrasonography, Model IE-ELite, with 2-4MHz phased array probe (S5-1 probe) was used for TCS to examine SN in our study.
Transcranial ultrasound study
Ultrasonography through temporal window, alon;
Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union HospitalNULLCompleted3684BothTarget condition:135;Difficult condition:0China
649JPRN-JapicCTI-142702
01/11/201412/11/2014A Phase 1 Study of ONO-2160/CDA Phase 1 study on single and multiple oral dose administration of ONO-2160/CD in healthy adult male subjects and on multiple oral dose administration of ONO-2160/CD in Parkinson's disease patients Parkinson's diseaseIntervention name : ONO-2160/CD
Dosage And administration of the intervention : Oral administration
Control intervention name : Levodopa/carbidopa hydrate
INN of the control intervention : Levodopa/carbidopa hydrate
Dosage And administration of the control intervention : Oral administration
ONO PHARMACEUTICAL CO.,LTD.NULLBOTH34Phase 1NULL
650NCT02312232
(ClinicalTrials.gov)
November 20142/12/2014Pharmacokinetic Study in Healthy MalesPharmacokinetics of Levodopa, Carbidopa, 3-OMD and ODM-104 After Repeated Doses of Different Formulations: an Open, Randomised, Multicentre Study With Crossover Design in Healthy MalesParkinson's DiseaseDrug: levodopa, carbidopa, ODM-104Orion Corporation, Orion PharmaNULLCompleted18 Years65 YearsMale20Phase 1Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
651NCT02240030
(ClinicalTrials.gov)
November 201411/9/2014Efficacy and Safety Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Investigating the Efficacy and Safety of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) (SPAN-PD™)Idiopathic Parkinson's DiseaseDrug: CVT-301 Low Dose;Drug: CVT-301 High Dose;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll351Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
652NCT02281474
(ClinicalTrials.gov)
November 201427/10/2014Nilotinib in Cognitively Impaired Parkinson Disease Patients 001Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-SynucleinParkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body DiseaseDrug: NilotinibGeorgetown UniversityNULLCompleted40 Years90 YearsBoth12Phase 1United States
653NCT02278588
(ClinicalTrials.gov)
November 201428/10/2014Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.Effect of 2.5 Years of Rasagiline Therapy on Progression of Cognitive Biomarkers Assessed by MRI in Parkinson's Disease.Parkinson's DiseaseDrug: RasagilineThomas GuttusoNULLCompletedN/AN/AAll45United States
654EUCTR2014-001131-36-ES
(EUCTR)
23/10/201403/09/2014A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by LevodopaA Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Germany
655EUCTR2014-001132-10-ES
(EUCTR)
23/10/201402/09/2014A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by LevodopaA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
656EUCTR2014-002295-87-IT
(EUCTR)
13/10/201429/09/2014A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. Parkinson's disease patients who suffer motor fluctuations willparticipate in the study
MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 100 mg + 25 mg compresse
Product Name: SINEMET 100 mg + 25 mg compresse
Product Code: NA
SynAgile CorporationNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Italy
657NCT02224664
(ClinicalTrials.gov)
October 201415/8/2014Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s DiseaseA Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson`s Disease And Motor FluctuationsParkinson`s DiseaseDrug: PF-06649751PfizerNULLCompleted30 Years80 YearsAll50Phase 1United States;Belgium
658NCT02274766
(ClinicalTrials.gov)
October 201422/10/2014Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced DyskinesiaADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll77Phase 3United States;Austria;France;Germany;Spain
659NCT02274324
(ClinicalTrials.gov)
October 201422/10/2014Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s DiseaseDietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's DiseaseParkinson DiseaseDietary Supplement: different dietsSheba Medical CenterTel Aviv UniversityNot yet recruiting40 Years80 YearsBoth20N/ANULL
660NCT02259049
(ClinicalTrials.gov)
October 20143/10/2014The Effects of L-Tyrosine on 24 Hour Blood Pressure and Heart Rate in Parkinson's DiseaseThe Effects of L-Tyrosine on Non-invasive Ambulatory Blood Pressure and Heart Rate Monitoring in Parkinson's DiseaseBlood PressureDietary Supplement: L-tyrosine;Dietary Supplement: Sugar PillNew York Institute of TechnologyNULLCompleted40 Years84 YearsBoth6Phase 0United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
661NCT02183519
(ClinicalTrials.gov)
October 20142/7/2014Respiratory Kinematics of Cough in Healthy Older Adults and Parkinson's DiseaseRespiratory Kinematics of Reflex and Voluntary Cough in Healthy Older Adults and Parkinson's DiseaseCough;Parkinson's DiseaseDrug: Capsaicin;Other: Voluntary cough testUniversity of FloridaNULLCompleted55 Years85 YearsAll44Phase 1;Phase 2United States
662JPRN-UMIN000016893
2014/09/2201/04/2015A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression.A double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression. - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine. PD patientsThe treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.
The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.
Ehime University HospitalDept. of Clinical pharmacology and NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Phase 2Japan
663NCT02236260
(ClinicalTrials.gov)
September 3, 201429/8/2014Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain StimulationEvaluation of the Benefit Provided by the Addition of Acupunctural Analgesia With Electrostimulation to Conventional Local Anesthesia Compared to Conventional Local Anesthesia Alone in Surgery of Deep Brain Stimulation for Movement Disorders.Parkinson's DiseaseProcedure: Electroacupuncture;Drug: Local Anesthesia (lidocaine hydrochloride)Nantes University HospitalNULLCompleted18 Years74 YearsAll20N/AFrance
664NCT02256319
(ClinicalTrials.gov)
September 201430/9/2014Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity Measured Through Implanted StimulatorsEffects of Dexmedetomidine vs Propofol on the Recordings of Deep Brain Activity (Local Field Potentials) Measured Through Implanted StimulatorsParkinson's DiseaseDrug: Dexmedetomidine;Drug: PropofolClinica Universidad de Navarra, Universidad de NavarraNULLCompleted18 YearsN/ABoth12Phase 4Spain
665NCT03151460
(ClinicalTrials.gov)
September 20149/5/2017Dopaminergic Modulation of Declarative MemoryDopaminergic Modulation of Declarative MemoryParkinson's DiseaseDrug: Dopamine AgentI.R.C.C.S. Fondazione Santa LuciaNULLCompletedN/AN/AAll40Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
666NCT02777060
(ClinicalTrials.gov)
September 20148/6/2015Exploring the Effectiveness of Sensor-based Balance Training on Patient Outcome MeasuresExploring the Effectiveness of Sensor-based Balance Training on Patient Outcome MeasuresDiabetes;Cancer;Multiple Sclerosis;Arthritis;Parkinson's Disease;Cognitive Disorders;Brain Injury;StrokeProcedure: Exergame;Procedure: Home based balance trainingUniversity of ArizonaNULLRecruiting18 YearsN/ABoth200N/AUnited States
667NCT02225548
(ClinicalTrials.gov)
September 201422/8/2014Sagene 2014 - Parkinson's Disease and Erectile DysfunctionAn Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction.Parkinson's Disease;Erectile DysfunctionDrug: Selegiline;Drug: TadalafilUniversity of South FloridaNULLRecruiting40 Years64 YearsMale10Phase 4United States
668NCT02228590
(ClinicalTrials.gov)
August 31, 201426/8/2014A Study to Examine APL-130277 in Patients With Parkinson's DiseaseA Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: APL-130277SunovionNULLCompleted18 Years80 YearsAll20Phase 2United States
669ChiCTR-TRC-14005143
2014-08-252014-08-14A traditional chinese medicine clinical intervention study of depressed Parkinson's disease - based on the Wenyang Jieyu methodA traditional chinese medicine clinical intervention study of depressed Parkinson's disease - based on the Wenyang Yieyu method Depressed Parkinson's diseaseChinese Medicines:Formula granule;Western Medicine group:Venlafaxine hydrochloride sustained-release capsules ;The Third Affiliated Hospital of Beijing University of Traditional Chinese MedicineNULLRecruiting5575BothChinese Medicines:60;Western Medicine group:60;2 (Phase 2 study)China
670NCT02153645
(ClinicalTrials.gov)
August 18, 201430/5/2014Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesias (LID)Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tabletsOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll87Phase 3United States;Canada;France;Germany;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
671NCT02216188
(ClinicalTrials.gov)
August 201412/8/2014Follow-up Study to Assess One Boost Immunization With AFFITOPE® PD01A With Regard to Safety and Clinical ActivityPhase IB Follow-up, Randomized, Controlled, Parallel Group, Patient-blinded, Single-center Study to Assess One Boost With AFFITOPE® PD01A With Regard to Safety/Tolerability, Immunological + Clinical Activity in Patients Who Have Received the Vaccine Within the Study AFF008Parkinson's DiseaseBiological: AFFITOPE® PD01A;Other: ControlAffiris AGNULLCompleted40 Years68 YearsBoth28Phase 1Austria
672NCT02230267
(ClinicalTrials.gov)
August 201427/8/2014High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's DiseaseHigh-intensity Exercise and Fall Prevention Boot Camp for Parkinson's DiseaseParkinson's DiseaseOther: High intensity exercise and balance training;Other: Usual care arm exerciseUniversity of Nevada, Las VegasNULLCompleted45 Years85 YearsBoth27Phase 2United States
673NCT02438215
(ClinicalTrials.gov)
August 20147/8/2014Study of IRX4204 for Treatment of Early Parkinson's DiseaseAn Open-Label, Single Site Study Using [123I]ß-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease SubjectsParkinson's DiseaseDrug: IRX4204Io TherapeuticsNULLCompleted18 YearsN/ABoth15Phase 1United States
674NCT02236065
(ClinicalTrials.gov)
August 20148/9/2014Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative DisordersA Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative DisordersBrain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's DiseaseProcedure: Umbilical cord blood therapy;Biological: FilgrastimMinYoung Kim, M.D.NULLCompleted19 Years75 YearsAll10N/AKorea, Republic of
675NCT02153632
(ClinicalTrials.gov)
July 30, 201430/5/2014Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LIDA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: amantadine HCl ER;Drug: PlaceboOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll135Phase 3United States;Canada;France;Germany;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
676JPRN-UMIN000014709
2014/07/0101/08/2014Study on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2IStudy on Parkinson's disease and related disorders with dopamine transporter ligand [C-11]PE2I - DAT PET with [C-11]PE2I in PD and related disorders Patients of Parkinson's disease and related disordersThe dosage in the vein of [C-11]PE2I, [C-11]raclopride, and [F-18]FDG for PET/CT imaging.Tokyo Metropolitan Institute of GerontologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female200Not selectedJapan
677NCT02472210
(ClinicalTrials.gov)
July 201411/6/2015The Use of Botox in Advanced Parkinson's Patients Experiencing PainA Study of the Utility of Botulinum Toxin Type A for Pain in Advanced Parkinson's Disease Double Blind Placebo Control Crossover Pilot StudyParkinson's DiseaseDrug: Botulinum ToxinUniversity Health Network, TorontoNULLActive, not recruiting18 YearsN/ABoth14Phase 4NULL
678NCT02202551
(ClinicalTrials.gov)
July 201425/7/2014Open-Label Safety Study of ADS-5102 in PD Patients With LIDOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll223Phase 3United States;Austria;Canada;France;Germany;Spain
679EUCTR2014-000868-17-ES
(EUCTR)
26/06/201417/03/2014Effect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulatorsEffect of dexmedetomidine vs propofol on basal ganglia activity (local field potentials) recorded through implanted stimulators Parkinson's disease
MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Trade Name: Dexdor
Product Name: Dexdor
INN or Proposed INN: DEXMEDETOMIDINE
Other descriptive name: DEXMEDETOMIDINA
Trade Name: Propofol-Lipuro
Product Name: Propofol-Lipuro
INN or Proposed INN: PROPOFOL
Other descriptive name: PROPOFOL
Clínica Universidad de Navarra/Universidad de NavarraNULLNot RecruitingFemale: yes
Male: yes
Spain
680ChiCTR-TRC-14004707
2014-06-092014-05-27The effect of different patterns of rehabilitation training in idiopathic Parkinson's diseaseThe effect of different patterns of rehabilitation training in idiopathic Parkinson's disease Parkinson's diseaseTai Chi group:Tai Chi;Balance function training group:Balance function training;Shanghai Tongji HospitalNULLCompleted2090BothTai Chi group:30;Balance function training group:30;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
681EUCTR2013-000980-10-DK
(EUCTR)
06/06/201409/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Austria;Denmark;Netherlands;Germany
682NCT01971242
(ClinicalTrials.gov)
June 201423/10/2013Trial of Exenatide for Parkinson's DiseaseA Randomised, Double Blind, Placebo Controlled, Single Centre, 60 Week Trial of Exenatide Once Weekly for the Treatment of Moderate Severity Parkinson's DiseaseParkinson's DiseaseDrug: Exenatide;Other: PlaceboUniversity College, LondonNULLCompleted25 Years75 YearsBoth60Phase 2United Kingdom
683NCT02174250
(ClinicalTrials.gov)
June 201424/6/2014The Effect of Rifampin on the Metabolism of Istradefylline in Healthy Volunteers.Effect of a Strong Enzyme Inducer, Rifampin, on the Single-Dose Pharmacokinetics of Istradefylline in Healthy SubjectsParkinson's DiseaseDrug: Istradefylline 40 mg;Drug: Rifampin 300mg BID + istradefylline 40mg Day 8 onlyKyowa Hakko Kirin Pharma, Inc.NULLCompleted18 Years65 YearsBoth20Phase 1United States
684NCT02136914
(ClinicalTrials.gov)
May 20149/5/2014ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's DiseaseDrug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll126Phase 3United States;Canada
685EUCTR2012-005539-10-DE
(EUCTR)
29/04/201418/12/2013Clinical study to investigate the efficacy and safety of two dose levels of NT 201 versus placebo in treating chronic troublesome sialorrhea in various neurological conditions.Prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter study, with an extension period of dose-blinded active treatment, to investigate the efficacy and safety of two dose levels of NT 201 in treating chronic troublesome sialorrhea in various neurological conditions - SIAXI – Sialorrhea in Adults Xeomin Investigation Chronic troublesome sialorrhea resulting from neurological conditions in adults with Parkinson's disease or atypical parkinsonism (multiple system atrophy, corticobasal degeneration or progressive supranuclear palsy), or after stroke or traumatic brain injury.
MedDRA version: 18.1;Level: PT;Classification code 10039424;Term: Salivary hypersecretion;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Xeomin
INN or Proposed INN: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Trade Name: Xeomin
INN or Proposed INN: NT 101
Other descriptive name: BOTULINUM TOXIN TYPE A
Merz Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3United States;Poland;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
686EUCTR2013-002254-70-PL
(EUCTR)
28/04/201403/02/2014Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease Moderate to severe Parkinson's disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
687EUCTR2013-003363-64-GB
(EUCTR)
03/04/201411/03/2014Trial of Exenatide for Parkinson's diseaseA randomised, double blind, placebo controlled, single centre, 60 week trial of Exenatide once weekly for the treatment of moderate severity Parkinson’s disease. - Exenatide-PD Parkinson's Disease
MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Bydureon
Product Name: Exenatide
INN or Proposed INN: exenatide
University College LondonNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United Kingdom
688NCT03314597
(ClinicalTrials.gov)
April 2, 201415/10/2017Instrumental or Physical-Exercise Rehabilitation of Balance in Parkinson's Disease? (IPER-PD)Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.Parkinson's Disease;RehabilitationOther: Balance exercise;Other: Mobile platform exerciseUniversity of PaviaFondazione Salvatore MaugeriCompleted50 Years85 YearsAll38N/ANULL
689NCT02111122
(ClinicalTrials.gov)
April 20148/4/2014Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's DiseaseA Phase II, Prospective, Randomized, Double-blind, Crossover Placebo-controlled Study of the Symptomatic Effects of Nocturnal Sodium Oxybate in Parkinson's DiseaseSleep-wake Disturbances in Motor-phase Parkinson's DiseaseDrug: Sodium Oxybate;Drug: PlaceboChristian BaumannNULLCompleted18 Years90 YearsAll16Phase 2Switzerland
690NCT02091739
(ClinicalTrials.gov)
April 201418/3/2014Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsProspective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsChronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain InjuryDrug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: PlaceboMerz Pharmaceuticals GmbHNULLCompleted18 Years80 YearsAll184Phase 3Germany;Poland;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
691NCT02365012
(ClinicalTrials.gov)
April 201410/2/2015Treatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using MidodrineTreatment of Orthostatic Intolerance in Patients With Parkinson's Disease Using MidodrineOrthostatic Intolerance;Parkinson's DiseaseDrug: MidodrinePhiladelphia Veterans Affairs Medical CenterNULLRecruiting22 Years89 YearsBoth50N/AUnited States
692NCT02082249
(ClinicalTrials.gov)
March 10, 201414/2/2014An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLCompleted30 Years99 YearsAll23Phase 3Japan;Korea, Republic of;Taiwan
693EUCTR2013-002254-70-CZ
(EUCTR)
05/03/201402/12/2013Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's DiseaseRandomizovaná, multicentrická, dvojite zaslepená, placebem kontrolovaná, 12týdenní studie fáze 3 hodnotící úcinnost perorálního istradefylinu 20 a 40 mg/den v lécbe subjektu se stredne závažnou až závažnou Parkinsonovou nemocí Moderate to severe Parkinson's disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany
694EUCTR2013-000980-10-FR
(EUCTR)
03/03/201422/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
STADA Arzneimittel AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
695NCT02006121
(ClinicalTrials.gov)
March 3, 201422/11/2013Clinical Trial of Apomorphine Subcutaneous Infusion in Patients With Advanced Parkinson's DiseaseMulticentre,Parallel-group,Double-blind,Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Apomorphine sc Infusion in Parkinson's Disease Patients With Motor Complications Not Well Controlled on Medical TreatmentParkinson's DiseaseDrug: Apomorphine hydrochloride;Drug: PlaceboBritannia Pharmaceuticals Ltd.NULLCompleted30 YearsN/AAll107Phase 3Austria;Denmark;France;Germany;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
696NCT02006290
(ClinicalTrials.gov)
March 20145/12/2013Efficacy, Safety And Tolerability Study In Subjects With Parkinson's DiseaseA Phase 1b, Randomized, Subject And Investigator-Blinded, Sponsor-Open, Placebo Controlled, Cross-Over Efficacy, Safety And Tolerability Study Of Single Oral Split Dose Administration Of PF-06412562 In Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: PF-06412562;Drug: PlaceboPfizerNULLCompleted30 Years75 YearsBoth19Phase 1United States
697NCT02305030
(ClinicalTrials.gov)
March 201428/11/2014Effect of Opicapone at Steady State on Warfarin PharmacokineticsEffect of Opicapone at Steady State on Warfarin Pharmacokinetics in Healthy VolunteersParkinson's DiseaseDrug: BIA 9-1067;Drug: WarfarinBial - Portela C S.A.NULLCompleted18 Years45 YearsBoth20Phase 1NULL
698NCT02445651
(ClinicalTrials.gov)
March 201423/1/2015Physiological Effects of Nutritional Support in Patients With Parkinson's DiseasePhysiological Effects of Nutritional Support in Patients With Parkinson's DiseaseParkinson Disease;Idiopathic Parkinson DiseaseDietary Supplement: Intravenous and Oral n-acetyl cysteineThomas Jefferson UniversityNULLActive, not recruiting30 Years80 YearsAll65N/AUnited States
699NCT02305017
(ClinicalTrials.gov)
March 201428/11/2014Effect of Paracetamol on Opicapone Pharmacokinetics in Healthy VolunteersEffect of Paracetamol on Opicapone Pharmacokinetics in Healthy VolunteersParkinson's DiseaseDrug: BIA 9-1067;Drug: ParacetamolBial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
700EUCTR2013-002254-70-DE
(EUCTR)
28/02/201419/11/2013Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease Moderate to severe Parkinson's disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
701EUCTR2013-002254-70-IT
(EUCTR)
21/02/201427/11/2013Study to test the safety and effect of an investigational study drug, Istradefylline, in moderate to severe Parkinson's Disease (PD) patients who have been treated with levodopa combination therapy.A Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaulate the Efficacy of Oral Istradefylline 20 and 40 mg/day as Treatment for Subjects with Moderate to Severe Parkinson's Disease Moderate to severe Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Hakko Kirin Pharma, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
609Phase 3United States;Serbia;Czech Republic;Canada;Poland;Israel;Germany;Italy
702EUCTR2013-000980-10-ES
(EUCTR)
12/02/201412/11/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson?s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson?s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 16.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
STADA Arzneimittel AGNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
703EUCTR2013-000980-10-NL
(EUCTR)
06/02/201427/01/2014Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Germany;Netherlands
704NCT02305316
(ClinicalTrials.gov)
February 201428/11/2014Single-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of OpicaponeSingle-dose Pharmacokinetics and Relative Bioavailability of Two Different Formulations of Opicapone in Healthy VolunteersParkinson DiseaseDrug: BIA 9-1067 non-micronized;Drug: BIA 9-1067 micronizedBial - Portela C S.A.NULLCompleted18 Years45 YearsAll28Phase 1NULL
705NCT02007785
(ClinicalTrials.gov)
February 201414/11/2013Study of the Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) on Cognitive Impairment in Parkinson's DiseaseDetermining the Applicability of the Cognitive Orientation to Daily Occupational Performance (CO-OP) as a Meta-Cognitive Rehabilitation Strategy for Individuals With Parkinson's Disease-Related Cognitive ImpairmentParkinson's Disease;Cognitive ImpairmentBehavioral: CO-OP treatment protocolUniversity of ManitobaNULLCompleted40 YearsN/ABoth6N/ACanada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
706NCT02064166
(ClinicalTrials.gov)
February 201413/2/2014Treatment of Parkinson Disease and Multiple System Atrophy Using Intranasal Insulin.A Double-blinded Placebo-controlled Single-center Study to Evaluate the Efficacy of Intranasal Insulin 40 International Units Day as Treatment for Subjects With Parkinson Disease and Multiple System AtrophyParkinson Disease;Multiple System AtrophyDrug: Intranasal InsulinPeter NovakNULLCompleted18 YearsN/AAll15Phase 2United States
707EUCTR2013-002545-10-SE
(EUCTR)
08/01/201411/11/2013An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309 Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: OSU6162 similar to (-)-OSU 6162A. Carlsson Research ABNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Sweden
708NCT02046434
(ClinicalTrials.gov)
January 201423/1/2014Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the BrainPhenylbutyrate Response As a Biomarker for Alpha-Synuclein Clearance From BrainParkinson's DiseaseDrug: Glycerol PhenylbutyrateUniversity of Colorado, DenverNULLActive, not recruiting21 Years80 YearsAll40Phase 1United States
709NCT01968460
(ClinicalTrials.gov)
December 201315/10/2013Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's DiseaseA Phase 2B, Twelve-week Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study, To Determine the Safety, Tolerability and Efficacy of Two Doses of Once Daily P2B001 in Subjects With Early Parkinson's DiseaseParkinson's DiseaseDrug: P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),;Drug: Placebo;Drug: P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),Pharma Two B Ltd.NULLCompleted35 Years75 YearsAll149Phase 2;Phase 3United States;Israel
710NCT01883505
(ClinicalTrials.gov)
December 20139/6/2013A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612Parkinson's DiseaseDrug: Levodopa and carbidopa;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth30Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
711NCT02103465
(ClinicalTrials.gov)
December 201326/3/2014Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of DiseaseLate Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of RotigotineParkinson's DiseaseDrug: Rotigotine;Drug: PlaceboAzienda Ospedaliera Cardinale G. PanicoNULLTerminated70 YearsN/ABoth80Phase 2Italy
712NCT02018406
(ClinicalTrials.gov)
December 201330/10/2013Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain InjuryNeurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson DiseaseDrug: Combination injection of EPO and G-CSF;Drug: Injection of normal salineYonsei UniversityNULLActive, not recruiting20 YearsN/AAll16Phase 1;Phase 2Korea, Republic of
713NCT02108704
(ClinicalTrials.gov)
December 20134/4/2014Helicobacter Pylori Eradication Study in Parkinson's DiseaseHelicobacter Pylori Eradication in Parkinson's Disease: A Double-blind Randomised Placebo Controlled TrialParkinson's Disease;Helicobacter Pylori InfectionDrug: Helicobacter pylori eradication therapy;Drug: PlaceboUniversity of MalayaNULLCompleted18 YearsN/AAll75N/AMalaysia
714NCT04044547
(ClinicalTrials.gov)
November 22, 201330/7/2019A Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll60Phase 1NULL
715EUCTR2012-002840-26-RO
(EUCTR)
12/11/201317/07/2014Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
716NCT01927055
(ClinicalTrials.gov)
November 201316/8/2013A Clinical Study of Patients With Symptomatic NOH to Assess Sustained Effects of Droxidopa TherapyA Clinical Study of Patients With Symptomatic Neurogenic Orthostatic Hypotension to Assess Sustained Effects of Droxidopa TherapySymptomatic Neurogenic Orthostatic Hypotension;Parkinson's Disease;Multiple Systems Atrophy;Pure Autonomic Failure;Dopamine Beta Hydroxylase DeficiencyDrug: Droxidopa;Drug: PlaceboChelsea TherapeuticsNULLTerminated18 YearsN/AAll61Phase 3United States
717EUCTR2011-004438-32-DE
(EUCTR)
23/10/201313/08/2013The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptyingA randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism.
MedDRA version: 16.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GSK962040
Product Code: GSK962040
INN or Proposed INN: GSK962040
Other descriptive name: GSK962040
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
70Australia;Germany;United Kingdom;Sweden
718EUCTR2013-000980-10-AT
(EUCTR)
18/10/201331/07/2013Clinical trial of apomorphine subcutaneous infusion in patients with advanced Parkinson’s diseaseTOLEDO Multicenter, parallel-group, double-blind, placebo-controlled phase III study to evaluate the efficacy and safety of apomorphine subcutaneous infusion in Parkinson’s disease patients with motor complications not well controlled on medical treatment - TOLEDO Parkinson Disease (PD) in patients with motor fluctuations not well controlled on medical treatment
MedDRA version: 18.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go®
Product Name: Apomorphine hydrochloride
Product Code: Apo-go®
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: Apomorphine hydrochloride
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
102Phase 3France;Spain;Denmark;Austria;Netherlands;Germany
719NCT02055274
(ClinicalTrials.gov)
October 201331/1/2014Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson's DiseaseDrug: LY03003;Drug: NeuproLuye Pharma Group Ltd.NULLCompleted18 YearsN/ABoth39Phase 1United States
720NCT01960842
(ClinicalTrials.gov)
October 20139/10/2013A Study to Assess the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease (PD) and Persistent Motor Complications, Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of ABT-SLV187 Monotherapy in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVieNULLCompleted30 YearsN/AAll31Phase 3Japan;Korea, Republic of;Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
721EUCTR2011-002827-17-SK
(EUCTR)
17/09/201304/03/2013A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. Early stage Parkinson's Disease.
MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Local Trade Name, 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Local Trade Name, 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Local Trade Name, 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
722EUCTR2013-001881-40-GB
(EUCTR)
16/09/201305/08/2013Extension study to Assess the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)An Extension Study to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via onvection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease Parkinson's disease
MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
North Bristol NHS Trust (NBT)NULLNot Recruiting Female: yes
Male: yes
42Phase 2United Kingdom
723NCT01929317
(ClinicalTrials.gov)
August 28, 201322/8/2013A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease.Parkinson DiseaseDrug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tabletGlaxoSmithKlineNULLTerminated20 YearsN/AAll81Phase 3Japan
724EUCTR2013-001722-25-NL
(EUCTR)
27/08/201312/08/2013Rivastigmine as an early treatment for visual hallucinations in Parkinson’s disease (CHEVAL)Cholinesterase inhibitors to slow progression of visual hallucinations in Parkinson’s disease: a multi-center placebo-controlled trial (CHEVAL) - CHEVAL Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
VU University Medical CenterNULLNot Recruiting Female: yes
Male: yes
168Phase 4Netherlands
725EUCTR2011-004438-32-SE
(EUCTR)
26/08/201301/07/2013The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptyingA randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism.
MedDRA version: 16.0;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: GSK962040
Product Code: GSK962040
INN or Proposed INN: GSK962040
Other descriptive name: GSK962040
GlaxoSmithKline Research and Development LimitedNULLNot RecruitingFemale: yes
Male: yes
70Australia;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
726NCT01931488
(ClinicalTrials.gov)
August 201314/8/2013124I-MIBG Tracer Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors.The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG.Parkinson Disease;Neuroendocrine TumorsOther: MIBG label with I123 or I124;Device: SPECT imagingTel-Aviv Sourasky Medical CenterNULLRecruiting18 YearsN/ABoth40Phase 2Israel
727JPRN-UMIN000011111
2013/07/1615/07/2013Spinal blood flow and metabolism in neurological diseases motor neuron disease including ALS, multiple sclerosis, stroke, Parkinson disease, spinocerebellar degeneration, multiple system atrophyPET scan study with 11C-flumazenil
PET scan study with 18F- FDG
PET scan study with 15O-H2O
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical SciencesNULLRecruiting20years-oldNot applicableMale and Female70Not applicableJapan
728EUCTR2012-001245-40-IT
(EUCTR)
05/06/201317/05/2013CLINICAL AND PHARMACOLOGICAL STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®)CLINICAL AND PHARMACOKINETICS STUDY TO EVALUATE THE THERAPEUTIC EQUIVALENCE AND BIOEQUIVALENCE OF LEVODOPA BENSERAZIDE GENERIC FORMULATION (TEVA ITALIA) VERSUS THE ORIGINATOR (MADOPAR®) PARKINSON'S DISEASE
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Madopar 200+50 mg
Trade Name: LEVODOPA / BENSERAZIDE 200 + 50 MG
NULLNot RecruitingFemale: yes
Male: yes
Italy
729JPRN-JapicCTI-132189
01/6/201312/07/2013A Phase 1 Study of ONO-2160/CDA Phase 1 study on single oral dose administration of ONO-2160/CD in healthy adult male subjects and Parkinson's disease patients Parkinson's diseaseIntervention name : ONO-2160/CD
Dosage And administration of the intervention : Oral administration
Control intervention name : Levodopa/carbidopa hydrate
INN of the control intervention : Levodopa/Carbidopa Hydrate
Dosage And administration of the control intervention : Oral administration
ONO PHARMACEUTICAL CO.,LTD.NULLBOTH42Phase 1NULL
730NCT01879748
(ClinicalTrials.gov)
June 201313/6/2013A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of RasagilineA Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses (0.5, 1.0, and 2.0 mg) of Rasagiline Administered to Healthy Japanese and Caucasian SubjectsParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Pharmaceutical IndustriesNULLCompleted20 Years50 YearsBoth64Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
731JPRN-UMIN000010752
2013/05/1717/05/2013A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. Parkinson's diseasedonepezilKansai Medical UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female50Not selectedJapan
732EUCTR2012-005822-31-IT
(EUCTR)
13/05/201320/03/2013A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s diseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) Parkinson's Disease
MedDRA version: 15.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2bUnited States;Serbia;United Kingdom;Italy
733EUCTR2013-000827-15-IT
(EUCTR)
11/05/201315/03/2013LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINELATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Rotigotine
Product Name: neurpro
Product Code: SPM962
Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, TricaseNULLNot RecruitingFemale: yes
Male: yes
Italy
734JPRN-UMIN000010596
2013/05/0101/05/2013Randomized crossover trial comparing memantine or amantadine for Parkinson's disease with motor fluctuations in Juntendo Parkinson's diseaseMemantine preceding arm
Titrate the memantine, administered for 3 months. And tapering memantine and amantadine titrate the dose for 3 months.

Amantadine preceding arm
Titrate the amantadine, administered for 3 months. And tapering amantadine and memantine titrate the dose for 3 months.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale40Not selectedJapan
735NCT01851850
(ClinicalTrials.gov)
May 20131/5/2013Continuation Treatment Protocol for Patient Who Participated in the BIA 9-1067-302 Clinical TrialContinue Providing Care for Patient Who Participated in the BIA 9-1067-302 Clinical TrialParkinson DiseaseDrug: OpicaponeRabin Medical CenterNULLCompleted30 Years80 YearsAll1Phase 3Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
736NCT01860794
(ClinicalTrials.gov)
May 201314/5/2013Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's DiseaseInvestigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's DiseaseIdiopathic Parkinson Disease;Primary ParkinsonismDrug: Mesencephalic Neuronal Precursor CellsBundang CHA HospitalNULLRecruiting18 Years70 YearsFemale15Phase 1;Phase 2Korea, Republic of
737NCT03022201
(ClinicalTrials.gov)
May 201323/11/2016Comparing the Therapeutic Efficacy and Safety of DA-9701 With Domperidone in Patients With Parkinson's DiseaseTherapeutic Efficacy of DA-9701 on Gastric Motility in Patients With Parkinson's Disease Evaluated by Magnetic Resonance Imaging: A Randomized Controlled, Double-Blind, Non-Inferiority TrialParkinson's Disease,IdiopathicDrug: DA-9701;Drug: Domperidone;Drug: Placebo domperidone;Drug: Placebo DA-9701Seoul National University HospitalNULLCompleted20 Years80 YearsAll40Phase 4Korea, Republic of
738EUCTR2012-002840-26-BG
(EUCTR)
26/04/201306/02/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
739EUCTR2011-002827-17-EE
(EUCTR)
23/04/201308/02/2013A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. Early stage Parkinson's Disease.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: REQUIP-MODUTAB , 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB , 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB , 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
740EUCTR2011-002828-41-EE
(EUCTR)
23/04/201308/02/2013A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease.A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. Advanced Parkinson's disease.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: REQUIP-MODUTAB, 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB, 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB, 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
406United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
741EUCTR2012-005822-31-GB
(EUCTR)
18/04/201305/03/2013A study of the safety and drug effects of levodopa inhalation powder (CVT-301) in patients with Parkinson’s diseaseA Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson’s Disease Patients With Motor Response Fluctuations (OFF Phenomena) - Inhaled CVT-301 in Subjects with Parkinson’s Disease Parkinson's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2bUnited States;Serbia;Italy;United Kingdom
742JPRN-UMIN000010778
2013/04/1022/05/2013Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1Delayed start study of donepezil hydrocloride for cognitive decline in Parkinson disease following EDAP-1 - EDAP-2 Parkinson disease5mg donepezil hydroclorideNational Hospital of UtanoNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
743JPRN-UMIN000010371
2013/04/0801/04/2013Study of zonisamide ( TRERIEF&reg; tablet 25mg ) to tremor in patients with early Parkinson's disease. Parkinson's diseaseStart 25mg of Zonisamide and carry out observation 24weeks.
Evaluate start point, after 4weeks, after 8weeks, after 16weeks, and after 24weeks.
Department of Neurology, University of YamanashiNULLPendingNot applicableNot applicableMale and Female10Not selectedJapan
744EUCTR2012-002608-42-GB
(EUCTR)
07/04/201301/11/2012A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain Parkinson’s disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
UCB Biosciences GmbHNULLNot Recruiting Female: yes
Male: yes
478Phase 4France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
745NCT02005029
(ClinicalTrials.gov)
April 201318/9/2013Erythromycin in Parkinson's DiseaseErythromycin in Parkinson's Disease: A Pilot Study of Its Effects on Levodopa Pharmacokinetics and PharmacodynamicsParkinson's Disease;LevodopaDrug: Erythromycin;Drug: placeboVirginia Commonwealth UniversityNULLCompleted18 Years80 YearsAll18N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
746NCT01829867
(ClinicalTrials.gov)
April 20139/4/2013A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular InfusionParkinson's DiseaseDrug: sNN0031Newron Sweden ABNULLTerminated55 Years75 YearsBoth5Phase 1Sweden
747NCT01777555
(ClinicalTrials.gov)
April 201323/1/2013Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF EpisodesA Phase 2b, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Inhaled CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: PlaceboAcorda TherapeuticsNULLCompleted30 Years80 YearsAll89Phase 2United States;Italy;Serbia;United Kingdom
748EUCTR2011-002828-41-SK
(EUCTR)
27/03/201304/03/2013A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease.A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. Advanced Parkinson's disease.
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Requip Modutab, 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Requip Modutab, 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Requip Modutab, 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
406United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
749EUCTR2012-002840-26-SI
(EUCTR)
26/03/201318/03/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4United States;Serbia;Slovenia;Slovakia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
750NCT04627155
(ClinicalTrials.gov)
March 15, 20135/11/2020A Study to Evaluate the Human Tolerance and Pharmacokinetics of LY03003A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Human Tolerance and Kinetics of LY03003 By Single Intramuscular InjectionParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLCompleted18 Years45 YearsAll20Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
751JPRN-UMIN000009958
2013/03/0801/03/2013Effects of donepezil on the prognosis of Parkinson's disease with severe olfactory dysfunction Parkinson's diseaseDonepezil hydrochloride added to standard therapy
Placebo added to standard therapy
National Hospital Organization, Sendai-Nishitaga HospitalNULLComplete: follow-up complete55years-old75years-oldMale and Female200Not applicableJapan
752EUCTR2012-002840-26-AT
(EUCTR)
05/03/201306/11/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4United States;Serbia;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
753NCT01736176
(ClinicalTrials.gov)
March 201327/11/2012A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's DiseaseAn Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) TabletsAbbVie (prior sponsor, Abbott)NULLCompleted30 YearsN/AAll39Phase 3United States
754NCT01780467
(ClinicalTrials.gov)
March 201321/1/2013Role of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian PatientsRole of Dopamine on Loss Aversion Behaviour: Study on Parkinsonian Patients.Parkinson's DiseaseBehavioral: Role of dopamineUniversity Hospital, Clermont-FerrandNULLNot yet recruiting35 Years75 YearsBoth40Phase 4France
755JPRN-UMIN000010014
2013/02/2813/02/2013Randomized Double-blind, Placebo-controlled multi-center trial on molecular hydrogen water in Parkinson Disease Parkinson's disesasehydrogen water made by "Suisosui5.0"
placebo-water (nitrogen filling water)
Juntendo University School of Medicine, NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female200Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
756EUCTR2012-002840-26-IT
(EUCTR)
18/02/201311/01/2013Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 3-ARM, PHASE 4 STUDY TO EVALUATE THE EFFICACY OF ROTIGOTINE ON PARKINSON’S DISEASE-ASSOCIATED APATHY, MOTOR SYMPTOMS, AND MOOD Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
INN or Proposed INN: ROTIGOTINE
UCB BIOSCIENCES GMBHNULLNot RecruitingFemale: yes
Male: yes
600Phase 4United States;Hungary;Slovenia;Spain;Ukraine;Turkey;Austria;Bulgaria;Russian Federation;Italy
757EUCTR2012-002840-26-HU
(EUCTR)
11/02/201313/12/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
758NCT01782222
(ClinicalTrials.gov)
February 201330/1/2013Trial to Evaluate The Efficacy Of Rotigotine on Parkinson's Disease-Associated Motor Symptoms And ApathyA Multicenter, Multinational, Double-Blind, Placebo-Controlled, 3-Arm, Phase 4 Study To Evaluate The Efficacy Of Rotigotine On Parkinson's Disease-Associated Apathy, Motor Symptoms, And MoodIdiopathic Parkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB BIOSCIENCES GmbHNULLCompleted18 YearsN/AAll122Phase 4United States;Austria;Hungary;Poland;Slovakia;Slovenia;Spain
759NCT01789385
(ClinicalTrials.gov)
February 20132/2/2013Anesthesia for Deep Brain StimulationAnesthesia for Deep Brain Stimulation for the Treatment of Parkinsons DiseaseParkinsons DiseaseDrug: DexmedetomidineDiskapi Teaching and Research HospitalNULLCompleted19 Years85 YearsBoth26Phase 4Turkey
760NCT01766128
(ClinicalTrials.gov)
February 20138/1/2013Study of Zonisamide in Early Parkinson DiseaseRandomized Double Blind Placebo-controlled Study of Zonisamide Effectiveness in Early Parkinson DiseaseParkinson DiseaseDrug: ZonisamideMazandaran University of Medical SciencesNULLNot yet recruiting45 Years85 YearsBoth60Phase 2;Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
761NCT02059733
(ClinicalTrials.gov)
February 20137/2/2014Developing a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and ParkinsonismDeveloping a Novel Imaging Biomarker in the Differential Diagnosis of Parkinson's Disease and Parkinsonism by 18F-DTBZ PETParkinson's DiseaseDrug: 18F-DTBZChang Gung Memorial HospitalNULLCompleted20 Years80 YearsAll72Phase 2Taiwan
762EUCTR2012-002840-26-ES
(EUCTR)
23/01/201329/11/2012Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Romania;Croatia;Bulgaria
763EUCTR2012-002608-42-DE
(EUCTR)
10/01/201326/09/2012A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain Parkinson’s disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
64United States;Hungary;Slovakia;Poland;Germany;United Kingdom
764EUCTR2012-002608-42-HU
(EUCTR)
10/01/201312/11/2012A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain Parkinson’s disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
478France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
765EUCTR2012-002840-26-SK
(EUCTR)
07/01/201309/03/2016Study to test the efficacy of two doses of Rotigotine on depressive mood (apathy) associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 3-arm Phase 4 Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease- Associated Apathy, Motor Symptoms, and Mood Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
504Phase 4Serbia;United States;Slovakia;Slovenia;Spain;Ukraine;Turkey;Austria;Italy;Hungary;Poland;Croatia;Romania;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
766JPRN-UMIN000017695
2013/01/0127/05/2015Oxybuprocaine for apraxia of lid opening in Parkinson's disease apraxia of lid opening in Parkinson's diseaseArm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment
Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment
Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up completeNot applicableNot applicableMale and Female10Not selectedJapan
767NCT01500707
(ClinicalTrials.gov)
January 201322/12/2011Single Dose Study to Assess the Pharmacokinetics of SCH 900800 in Subjects With Parkinson's Disease Being Treated With Levodopa (L-DOPA) (P08235)A Single Dose Study to Assess the Pharmacokinetics of SCH 900800 Administered as Oral Tablets in L-DOPA-treated Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: SCH 900800Merck Sharp & Dohme Corp.NULLWithdrawn30 Years85 YearsBoth0Phase 1NULL
768NCT03651856
(ClinicalTrials.gov)
January 20132/7/2018Atomoxetine for Freezing of Gait in Parkinson's DiseaseA Pilot Study of Atomoxetine for Freezing of Gait in Parkinson's DiseaseParkinson's Disease;Freezing of GaitDrug: ATM FOG in PDMedical University of South CarolinaNULLCompleted18 Years80 YearsAll10Phase 3United States
769NCT02100176
(ClinicalTrials.gov)
January 201324/3/2014MIRT and Rotigotine in the Early Stage of PDMultidisciplinary Intensive Rehabilitation Treatment and Rotigotine in the Early Stages of Parkinson's Disease: a Randomized Controlled Study.Parkinson's DiseaseOther: Multidisciplinary intensive rehabilitation treatment;Drug: RotigotineOspedale Generale Di Zona Moriggia-PelasciniNULLRecruiting50 Years75 YearsBoth40N/AItaly
770EUCTR2012-002608-42-SK
(EUCTR)
17/12/201209/03/2016A study to evaluate the efficacy of Rotigotine (the treatment) versus placebo in patients with pain associated with Parkinson's DiseaseA Multicenter, Multinational, Double-blind, Placebo-controlled, 2-arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated Pain Parkinson’s disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro
Product Name: Rotigotine
INN or Proposed INN: ROTIGOTINE
UCB Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
478France;United States;Hungary;Mexico;Slovakia;Argentina;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
771NCT01725802
(ClinicalTrials.gov)
December 20124/11/2012A Phase I/IIa Study of Safety, Tolerability and Plasma Concentration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsA Phase I/IIa, Single Dose, Single-centre, Randomized, Crossover, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in PD PatientsParkinson's DiseaseDrug: levodopa and carbidopa solution for SC administration;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth8Phase 1;Phase 2Israel
772NCT02112812
(ClinicalTrials.gov)
December 201210/4/2014Effects of Helicobacter Pylori Infection Eradication in Patients With Parkinson's DiseaseA Study on Clinical Response Following Eradication Therapy of Helicobacter Pylori Infection in Parkinson's DiseaseResponse to Levodopa;Motor Outcomes;Quality of Life OutcomesDrug: Eradication therapy for H.pylori infection;Drug: Eradication of Helcobacter Pylori;Drug: Eradication therapy for Helicobacter pyloriNational University of MalaysiaNULLCompleted17 YearsN/ABoth82N/AMalaysia
773NCT01770145
(ClinicalTrials.gov)
December 20127/1/2013Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa ActionParkinson's Disease;Motor Symptoms;Akinesia;Hypomobility;Delayed Levodopa OnsetDrug: APOKYN;Drug: L-dopa;Drug: TrimethobenzamideUS WorldMeds LLCNULLCompleted18 YearsN/AAll127Phase 4United States
774NCT01744496
(ClinicalTrials.gov)
November 20125/12/2012Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated PainA Multicenter, Multinational, Double-Blind, Placebo-Controlled, 2-Arm Study to Evaluate the Efficacy of Rotigotine on Parkinson's Disease-Associated PainAdvanced Idiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB BIOSCIENCES GmbHNULLCompleted18 YearsN/AAll68Phase 4United States;Germany;Poland;Slovakia;Hungary;Korea, Republic of
775NCT01683253
(ClinicalTrials.gov)
November 20127/9/2012Remission of ICD by Switching Dopamine Agonist to Levodopa/CarbidopaThe REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement TherapyImpulse Control DisorderDrug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic AgonistsSandozNULLCompleted30 Years80 YearsAll150Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
776NCT01723228
(ClinicalTrials.gov)
November 20125/11/2012Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's DiseaseA 24-Week, Multicenter, Randomized, Double-blind, Placebo-Controlled, Add-on, Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Branded Pharmaceutical Products, R&D Inc.NULLCompleted45 Years80 YearsAll170Phase 4United States
777NCT01721460
(ClinicalTrials.gov)
November 201230/10/2012Effects of Dexmedetomidine on Activity in the Subthalamic NucleusEffects of Dexmedetomidine on Neuronal Activity in the Subthalamic Nucleus During Deep Brain Stimulation (DBS) Electrode Implantation SurgeryParkinson's Disease;Deep Brain Stimulation SurgeryDrug: DexmedetomidineUniversity of Wisconsin, MadisonNULLCompleted18 Years85 YearsAll6Phase 4United States
778NCT03652363
(ClinicalTrials.gov)
October 25, 201221/8/2018GDNF in ideopathicParkinsons DiseaseA Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal (GDNF) Infusions Administered Via Convection Enhanced Delivery (CED) in Subjects With Parkinson&Apos;s DiseaseIdiopathic Parkinson DiseaseDrug: glial cell line-derived neurotrophic factorNorth Bristol NHS TrustNULLCompleted35 Years75 YearsAll42Phase 2NULL
779JPRN-UMIN000009099
2012/10/0112/10/2012The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia Parkinson's diseaselidocaine injection into the external oblique
normal saline injection into the external oblique
Parkinson's disease and Movement Disorder CenterNULLRecruiting20years-oldNot applicableMale and Female10Not applicableJapan
780NCT01603069
(ClinicalTrials.gov)
October 201214/5/2012A Study to Assess Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's DiseaseA Phase IIa, 12 Week, Multicentre, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Tolerability of Oral AZD3241 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: AZD3241 300 mg BID;Drug: AZD3241 600 mg BID;Drug: PlaceboAstraZenecaNULLCompleted30 Years80 YearsBoth51Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
781NCT01796483
(ClinicalTrials.gov)
October 201213/2/2013EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PDExploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de ParkinsonParkinson DiseaseDevice: Clonidine (Catapressan);Device: Placebo 90 minutes before EEGHospices Civils de LyonNULLCompleted40 Years70 YearsAll37N/AFrance
782EUCTR2011-003866-34-GB
(EUCTR)
24/09/201201/05/2012Assessing the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)A Placebo-Controlled, Randomised, Double-Blind Trial to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease Parkinson's disease
MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
North Bristol NHS Trust (NBT)NULLNot Recruiting Female: yes
Male: yes
42Phase 2United Kingdom
783EUCTR2011-004378-27-AT
(EUCTR)
04/09/201220/07/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
784ChiCTR-OCS-12002720
2012-09-012012-11-26Pharmacogenetics study of anti-parkinson's disease drug levodopaThe association between polymorphisms of DRD2, DRD2, SLC6A3 and the levodopa response Parkinson's DiseaseA:levodopa;Institute of Clinical Pharmacology, Central South UniversityNULLCompleted3872BothA:200;NULL
785NCT01662791
(ClinicalTrials.gov)
September 20127/8/2012Weight Loss in Parkinson's Disease and Role of Small Bowel Bacterial OvergrowthWeight Loss in Parkinson's Disease and the Potential Role of Small Bowel Bacterial OvergrowthParkinson's DiseaseDrug: RifaximinMayo ClinicNULLCompleted18 YearsN/AAll49Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
786NCT01684475
(ClinicalTrials.gov)
September 201211/9/2012A STUDY TO EVALUATE THE EFFICACY OF CJH1 (CLR4001) IN PARKINSON'S DISEASEA STUDY TO EVALUATE THE EFFICACY OF CJH1 [CLR4001] IN THE TREATMENT OF PARKINSON'S DISEASEParkinson's DiseaseDrug: CJH1 (CLR4001)Alexandra Marine and General HospitalNULLRecruiting40 Years85 YearsBoth21Phase 1;Phase 2Canada
787EUCTR2011-004803-19-FI
(EUCTR)
16/08/201216/05/2012PET study in PD patientsA Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Product Name: AZD3241 Extended release tablets 100 mg
Product Code: AZD3241
Product Name: [11C]PBR28
Product Code: [11C]PBR28
Product Name: [18F]FE-PE2I
Product Code: [18F]FE-PE2I
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2AFinland;Sweden
788EUCTR2012-000122-21-DK
(EUCTR)
10/08/201207/06/2012Improving the blood pressure regulating system in patients with parkinsons diseaseAcethylcholineesterase inhibition and orthostatic hypotension in patients with parkinsons disease Ortostatic hypotension in patients with Parkinsons disease
MedDRA version: 14.1;Level: PT;Classification code 10031127;Term: Orthostatic hypotension;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Trade Name: Mestinon
Product Name: Mestinon
INN or Proposed INN: PYRIDOSTIGMINE BROMIDE
Other descriptive name: Mestinon
Department of Neurology, Roskilde HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Denmark
789NCT00947037
(ClinicalTrials.gov)
August 201224/7/2009Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension StudyAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease SubjectsParkinson's DiseaseDrug: AP-CD/LDIntec Pharma Ltd.NULLWithdrawn30 Years95 YearsBoth0Phase 2Israel
790NCT02419313
(ClinicalTrials.gov)
August 201227/1/2014Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized ApproachInvestigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized ApproachParkinson;TremorDrug: incobotulinumtoxinA;Drug: SalineYale UniversityNULLCompleted18 YearsN/AAll33Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
791NCT02764892
(ClinicalTrials.gov)
August 201225/9/2015A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's DiseaseAn Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male VolunteersParkinson's DiseaseDrug: V81444Vernalis (R&D) LtdNULLCompleted25 Years55 YearsMale6Phase 1NULL
792JPRN-UMIN000008477
2012/07/1919/07/2012Clinical study of selegiline hydrochloride ( FP OD tablet 2.5) to flexion of spine in Parkinson's disease. Parkinson diseaseSelegiline hydrochloride 5mg 8weeks, 7.5mg 8weeks and stop it, followed after 8weeks, and evaluate each points.Department of Neurology, Juntendo Koshigaya HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
793JPRN-UMIN000008138
2012/07/0101/07/2012Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease Parkinson's diseaseSilodosin 8mg BIDJuntendo University School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale100Not selectedJapan
794NCT01646268
(ClinicalTrials.gov)
July 201218/7/2012Rotigotine Versus Placebo As Double Blind Study To Evaluate The Efficacy In Early Stage Idiopathic Parkinson's Disease PatientsA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study Of The Efficacy And Safety Of The Rotigotine Transdermal Patch In Chinese Subjects With Early-stage Idiopathic Parkinson's DiseaseIDIOPATHIC PARKINSON'S DISEASEDrug: Rotigotine;Drug: Placebo PatchUCB PharmaNULLCompleted30 YearsN/AAll249Phase 3China
795NCT01602549
(ClinicalTrials.gov)
July 201217/5/2012A Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric EmptyingA Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose Ranging Study to Assess the Effect of Repeat Doses of GSK962040 on the Pharmacokinetics of L-DOPA in Subjects With Parkinson's Disease Exhibiting Delayed Gastric EmptyingGastroparesisDrug: GSK962040 (25 mg tablet);Drug: PlaceboGlaxoSmithKlineNULLCompleted40 Years80 YearsAll58Phase 2Australia;Germany;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
796EUCTR2011-003053-25-GB
(EUCTR)
18/06/201201/05/2012The ReSPonD Study -Rivastigmine to Stabilise gait in Parkinson’s Disease. A study looking at whether Rivastigmine, a drug that can augment mental function, can stabilise walking in people with Parkinson's disease who have fallen.A randomised, double blind, placebo controlled trial to evaluate the effect of Rivastigmine on gait in people with Parkinson’s disease who have fallen. - ReSPonD Study - Rivastigmine to Stabilise gait in Parkinson’s Disease Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Research and Enterprise DepartmentNULLNot Recruiting Female: yes
Male: yes
130Phase 2United Kingdom
797JPRN-JapicCTI-121880
11/6/2012Phase II clinical study in patients with Parkinson's disease not taking L-DOPAA randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease not taking L-DOPA Parkinson's diseaseIntervention name : HP-3000(ropinirole hydrochloride patch)
Dosage And administration of the intervention : Transdermal, once daily
Control intervention name : HP-3000 placebo
Dosage And administration of the control intervention : Transdermal, once daily
Hisamitsu Pharmaceutical Co.,Inc.NULL2079BOTHPhase 2NULL
798JPRN-JapicCTI-121879
07/6/2012Phase II clinical study in patients with Parkinson's disease taking L-DOPAA randomized, double-blind, placebo-controlled, comparative study of HP-3000 in patients with Parkinson's disease taking L-DOPA Parkinson's diseaseIntervention name : HP-3000(ropinirole hydrochloride patch)
Dosage And administration of the intervention : Transdermal, once daily
Control intervention name : HP-3000 placebo
Dosage And administration of the control intervention : Transdermal, once daily
Hisamitsu Pharmaceutical Co.,Inc.NULL2079BOTHPhase 2NULL
799EUCTR2011-002074-23-AT
(EUCTR)
05/06/201207/05/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
800JPRN-UMIN000008057
2012/06/0106/06/2012Effect of enteral formula enriched with omega-3 fatty acid to prevention of weight reduction in patients with Parkinson's Disease Parkinson's DiseaseDaily oral administration of enteral nutrition formula (Racol NF) 400ml for 12 weeks consecutively.St. Mariannna University School of MedicineNULLComplete: follow-up complete35years-old80years-oldMale and Female25Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
801NCT02786667
(ClinicalTrials.gov)
June 201218/5/2016Non Motors Aspects in De Novo Parkinson's DiseaseNon Motors Aspects in De Novo Parkinson's Disease: Clinical and Physiopathological Description; Dopamine Agonist Treatment Effects.Parkinson Disease;ApathyDrug: Rotigotine;Drug: PlaceboUniversity Hospital, GrenobleNULLActive, not recruiting30 Years72 YearsAll199Phase 3France
802NCT01993680
(ClinicalTrials.gov)
June 201227/4/2012Orthostatic Dysregulation and Associated Gastrointestinal Dysfunction in Parkinson's Disease -TreatmentA Monocentric Randomized, Controlled, Double Blind, Crossover Phase II Trial to Show Non-inferiority of the Effect of Pyridostigmine Bromide vs. Fludrocortisone on Symptoms of Autonomic Dysregulation in Parkinson's DiseaseAutonomic Disturbances in Parkinson's DiseaseDrug: Pyridostigmine bromide;Drug: fludrocortisoneChristian BaumannNULLCompleted50 Years80 YearsAll18Phase 2Switzerland
803NCT01892176
(ClinicalTrials.gov)
June 201230/6/2013Effects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson DiseaseEffects of High-dose Coenzyme Q10 on Biomarkers of Oxidative Damage and Clinical Outcome in Parkinson DiseaseParkinson DiseaseDietary Supplement: coenzyme q10National University Hospital, SingaporeNULLCompleted21 MonthsN/ABoth20Phase 2;Phase 3Singapore
804EUCTR2012-001218-40-IT
(EUCTR)
21/05/201223/07/2012EFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTSEFFICACY OF ROTIGOTINE ON GAIT PERFORMANCE OF PARKINSONIAN PATIENTS Patients suffering for Idiopathic Parkinson’s Disease. H&Y stage > or = 2 with un-satisfactory control by on-going pharmacological therapy (Levodopa, COMT & MAO-inhibitors), characterised by an incomplete control of motor signs, in particular presence of early morning akinesia, as well as gait deficits in the morning.
MedDRA version: 14.1;Level: PT;Classification code 10056242;Term: Parkinsonian gait;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: NEUPRO*7CER 4MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*7CER 6MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*7CER 8MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 2MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 4MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 6MG/24H
INN or Proposed INN: rotigotina
Trade Name: NEUPRO*28CER 8MG/24H
INN or Proposed INN: rotigotina
FONDAZIONE SANTA LUCIANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
805EUCTR2011-004378-27-DE
(EUCTR)
15/05/201224/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
806EUCTR2011-004378-27-SK
(EUCTR)
02/05/201212/04/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
807JPRN-UMIN000007896
2012/05/0107/05/2012Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes Parkinson's disease and other parkinsonian syndromesThe patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
Kansai Medical UniversityNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
808NCT01652313
(ClinicalTrials.gov)
May 201223/7/2012Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and WomenA Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and WomenParkinson's DiseaseDrug: RasagilineH. Lundbeck A/SNULLCompleted18 Years45 YearsBoth12Phase 1China
809EUCTR2011-004438-32-GB
(EUCTR)
25/04/201218/04/2012The effect of repeat doses of GSK962040 on the pharmacokinetics of L-DOPA in subjects with Parkinson’s disease with slow gastric emptyingA randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the effect of repeat doses of GSK962040 on the pharmacokinetics of levodopa in subjects with Parkinson’s disease exhibiting delayed gastric emptying - GSK962040 Parkinson's disease PoC Investigate the ability of the motilin receptor agonist GSK962040 to improve levodopa pharmacokinetics (PK) by enhancing GE via motilin receptor agonism.
MedDRA version: 20.1;Level: PT;Classification code 10051153;Term: Diabetic gastroparesis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
GlaxoSmithKline Research and Development LimitedNULLNot Recruiting Female: yes
Male: yes
70Phase 2Germany;United Kingdom;Sweden
810EUCTR2012-000181-37-GB
(EUCTR)
25/04/201227/02/2012A study investigating the safety of CVT-301 in patients with Parkinson's DiseaseA Randomized, Placebo-Controlled Phase 2 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CVT-301 (Levodopa Inhalation Powder) in Patients with Parkinson’s Disease and Motor Response Fluctuations (Off” Episodes) Parkinson's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301
INN or Proposed INN: LEVODOPA
Trade Name: Sinemet®
Product Name: SINEMET® Plus 25 mg/100 mg Tablets
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
24Phase 2Serbia;Israel;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
811NCT01494532
(ClinicalTrials.gov)
April 2, 20121/12/2011A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's DiseaseA Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's DiseaseParkinson DiseaseDrug: ropinirole/L-dopa;Drug: placebo/L-dopaGlaxoSmithKlineNULLCompleted30 YearsN/AAll352Phase 4United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland
812EUCTR2011-005839-91-ES
(EUCTR)
02/04/201211/01/2012Gabapentin in the disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo.Gabapentin int he disorder of the impulse control in the Parkinson´s Disease: multicentric study, double-blind, randomized, controlled with placebo. - IMULPARK PARKINSON´S DISEASE
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GABAPENTINA KERN PHARMA
INN or Proposed INN: GABAPENTINA
Other descriptive name: GABAPENTIN
ASOCIACIÓN INSTITUTO BIODONOSTIANULLNot RecruitingFemale: yes
Male: yes
100Phase 2Spain
813JPRN-JapicCTI-122000
01/4/201202/11/2012Long-term study of FPF1100NW monotherapyLong-term study on FPF1100NW monotherapy with early Parkinson's disease patients Early Parkinson's diseaseIntervention name : FPF1100NW
INN of the intervention : Selegiline
Dosage And administration of the intervention : oral
Control intervention name : null
FP Pharmaceutical Corp.NULLBOTH130Phase 2NULL
814JPRN-UMIN000007617
2012/04/0130/03/2012Effect of lidocaine injection for postural deformities in Parkinson's disease Parkinson's diseaseintramuscular injection of lidocaineDept. of Clinical pharmacology and Neurology, Ehime UniversityNULLRecruiting20years-old80years-oldMale and Female30Not selectedJapan
815ChiCTR-TTRCC-12002751
2012-04-012012-11-26Clinical pharmacology study of anti-parkinson's drug pramipexoleA rondomised clinical trial of the potential drug-drug interaction between pramipexole and metformin Parkinson's diseaseA:Given pramipexole only;B:Given pramipexole and metformin simultaneously ;Institute of Clinical Pharmacology, Central South UniversityNULLCompleted1926MaleA:18;B:18;I (Phase 1 study)China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
816NCT01331122
(ClinicalTrials.gov)
April 201213/10/2010Study to Assess Droxidopa in the Treatment of Freezing Of Gait Symptoms in Patients With Parkinson's DiseaseA Phase II, Double-Blind, Placebo-Controlled Randomized Crossover Study to Assess the Clinical Benefit and Safety of Droxidopa in the Treatment of Freezing of Gait Symptoms in Patients With Parkinson's DiseaseGait Disorders, NeurologicDrug: droxidopaChelsea TherapeuticsNULLWithdrawn30 YearsN/ABoth0Phase 1;Phase 2United States;Canada
817NCT01527695
(ClinicalTrials.gov)
April 201222/12/2011PET Study in Parkinson's Disease PatientsA Phase IIA, Multi Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment With Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ER tablet 25 mg AZD3241;Drug: ER tablet 100 mg AZD3241;Drug: Placebo for AZD3241 25 mg;Drug: Placebo for AZD3241 100 mgAstraZenecaNULLCompleted45 Years75 YearsBoth24Phase 2Sweden
818NCT01556165
(ClinicalTrials.gov)
April 201213/3/2012Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of Rasagiline in Early Parkinson's Disease Patients Not Treated With Levodopa in ChinaParkinson's DiseaseDrug: rasagiline;Drug: placeboH. Lundbeck A/SNULLCompleted35 YearsN/AAll130Phase 3China
819NCT01550484
(ClinicalTrials.gov)
April 20126/3/2012A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement DisordersAn Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain DiagnosisParkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's DiseaseDrug: 18F-AV-133Avid RadiopharmaceuticalsNULLCompleted40 YearsN/AAll170Phase 2;Phase 3United States;Australia
820NCT01523301
(ClinicalTrials.gov)
April 201227/1/2012Rotigotine Versus Placebo to Evaluate the Efficacy on Depressive Symptoms in Idiopathic Parkinson's Disease PatientsDouble Blind, Placebo-controlled, Parallel, Multicenter, Randomized Interventional Phase IV Study to Evaluate the Efficacy of Rotigotine on Depressive Symptoms in Idiopathic Parkinson's Disease PatientsIdiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB Korea Co., Ltd.NULLCompleted20 YearsN/AAll380Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
821NCT01486628
(ClinicalTrials.gov)
April 20124/12/2011Study of Subcutaneous Continuous Administration of Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersA Phase I, Single Dose, Single-centre, Randomized, Double-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Levodopa Plasma Concentration Following Administration of Subcutaneous Continuously-delivered Levodopa/Carbidopa Solution (ND0612) in Healthy VolunteersParkinson's DiseaseDrug: ND0612;Drug: PlaceboNeuroDerm Ltd.NULLCompleted18 Years40 YearsMale36Phase 1Israel
822NCT01491529
(ClinicalTrials.gov)
April 201212/12/2011Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years80 YearsAll154Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
823EUCTR2011-002074-23-ES
(EUCTR)
30/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
92France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
824EUCTR2011-002074-23-SK
(EUCTR)
28/03/201230/03/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
92United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
825EUCTR2011-004378-27-HU
(EUCTR)
28/03/201215/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65United States;France;Hungary;Canada;Spain;Austria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
826EUCTR2011-004378-27-IT
(EUCTR)
27/03/201202/03/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
65United States;Hungary;Canada;Spain;Austria;Germany;Italy
827EUCTR2011-002074-23-HU
(EUCTR)
21/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
828EUCTR2011-002074-23-DE
(EUCTR)
20/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
829EUCTR2011-002074-23-IT
(EUCTR)
15/03/201202/03/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe Ldopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
92United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
830EUCTR2011-002901-31-DE
(EUCTR)
08/03/201206/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
831NCT01538329
(ClinicalTrials.gov)
March 201220/2/2012Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's DiseaseImpact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study)Parkinson DiseaseDrug: placebo;Drug: AmantadineUniversity Hospital, ToulouseNULLRecruiting35 YearsN/ABoth202Phase 2France
832NCT01519882
(ClinicalTrials.gov)
March 201224/1/2012Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's DiseaseA Multi-Centre, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Rotigotine on Sleep Efficiency in Patients With Advanced Parkinson's Disease.Advanced Idiopathic Parkinson's DiseaseOther: Placebo;Other: RotigotineUCB Pharma SANULLTerminated18 YearsN/AAll1Phase 4United Kingdom
833NCT01653132
(ClinicalTrials.gov)
March 201225/7/2012Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/ParkinsonismRandomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/ParkinsonismSialorrheaDrug: Incobotulinum Toxin A;Drug: PlaceboBeth Israel Deaconess Medical CenterNULLCompleted18 Years90 YearsAll10Phase 2United States
834NCT01491932
(ClinicalTrials.gov)
March 20121/12/2011Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll129Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
835NCT03061513
(ClinicalTrials.gov)
February 28, 201213/2/2017Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial BiomarkersUbiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial BiomarkersParkinson DiseaseDrug: Ubiquinol;Dietary Supplement: PlaceboWeill Medical College of Cornell UniversityNULLCompleted40 Years75 YearsAll11Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
836EUCTR2011-004803-19-SE
(EUCTR)
22/02/201216/12/2011PET study in PD patientsA Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Product Name: AZD3241 Extended release tablets 100 mg
Product Code: AZD3241
Product Name: [11C]PBR28
Product Code: [11C]PBR28
Product Name: [18F]FE-PE2I
Product Code: [18F]FE-PE2I
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2AFinland;Sweden
837EUCTR2011-005054-59-RO
(EUCTR)
21/02/201213/06/2013SYN115 in Parkinson’s diseaseA double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none) Parkinson’s disease
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SYN115 Tablets, 60 mg
Product Code: SYN115
INN or Proposed INN: tozadenant
Other descriptive name: tozadenant
Biotie Therapies Inc.NULLNot RecruitingFemale: yes
Male: yes
400United States;Canada;Argentina;Ukraine;Romania;Chile
838EUCTR2010-019894-13-IT
(EUCTR)
17/02/201202/03/2012The Parkinson's Progression Markers Initiative (PPMI)The Parkinson's Progression Markers Initiative (PPMI) - PPMI Parkinson Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trade Name: DaTSCAN
INN or Proposed INN: IOFLUPANE (123I)
MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Italy;United States
839NCT01539837
(ClinicalTrials.gov)
February 201222/2/2012A Pilot Clinical Trial With the Iron Chelator Deferiprone in Parkinson's DiseaseA Pilot Clinical Trial With the Iron Chelator Deferiprone in Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone 20mg;Drug: Placebo;Drug: Deferiprone 30mgImperial College LondonNULLCompleted50 Years75 YearsAll22Phase 2United Kingdom
840NCT01525641
(ClinicalTrials.gov)
February 20121/2/2012Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseSpecial Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Mirapex LABoehringer IngelheimNULLCompletedN/AN/AAll615N/AJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
841NCT01673724
(ClinicalTrials.gov)
February 201223/8/2012Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's DiseaseEffect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized StudyParkinson's DiseaseDrug: pramipexole;Drug: BromocriptineSandozNULLCompleted30 YearsN/AAll121Phase 4Korea, Republic of
842NCT01568099
(ClinicalTrials.gov)
February 201216/3/2012Tolerability and Safety of Subcutaneous Administration of Two Doses of AFFITOPE® PD01A in Early Parkinson's DiseaseA Randomized, Controlled, Parallel Group, Patient-blinded, Single-center, Phase I Pilot Study to Assess Tolerability and Safety of Repeated Subcutaneous Administration of Two Doses of AFFITOPE® PD01A Formulated With Adjuvant to Patients With Parkinson's DiseaseParkinson's DiseaseBiological: AFFITOPE® PD01A;Other: ControlAffiris AGNULLCompleted40 Years65 YearsBoth32Phase 1Austria
843NCT01485172
(ClinicalTrials.gov)
January 31, 20121/12/2011A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's DiseaseA Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's DiseaseParkinson DiseaseDrug: ropinirole monotherapy;Drug: placebo monotherapyGlaxoSmithKlineNULLCompleted30 YearsN/AAll186Phase 4United States;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland
844EUCTR2009-015170-35-GB
(EUCTR)
27/01/201221/12/2011Study across 22 UK hospitals investigating if a drug called Donepezil Hydrochloride can help people with an early form of Parkinson's Disease dementia.Multicentre UK Study of the Acetylcholinesterase Inhibitor Donepezil in Early Dementia Associated with Parkinson's Disease (MUSTARDD-PD) - Donepezil in Early Dementia Associated with Parkinson's Disease Parkinson's disease with mild dementia (PDD);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]The Newcastle upon Tyne Hospitals NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
500Phase 3United Kingdom
845NCT01536015
(ClinicalTrials.gov)
January 201215/2/2012Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease (PD) With Motor Fluctuations and Symptoms of Gastrointestinal DysfunctionA Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Effect of Rotigotine on Motor Symptoms in Patients With Advanced Parkinson's Disease With Motor Fluctuations and Symptoms of Gastrointestinal DysfunctionAdvanced Parkinson's DiseaseDrug: Rotigotine;Drug: PlaceboUCB PharmaNULLTerminated30 YearsN/AAll25Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
846NCT01515410
(ClinicalTrials.gov)
January 201211/1/2012Study in Advanced Parkinson's Disease Patients With Predictable Motor FluctuationsA Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor FluctuationsParkinson's Disease;Motor FluctuationsDrug: DM-1992;Drug: Sinemet IRDepomedNULLCompleted30 YearsN/AAll34Phase 2United States
847EUCTR2011-002901-31-HU
(EUCTR)
21/12/201113/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Czech Republic;Hungary;Spain;Germany;United Kingdom
848EUCTR2009-017412-32-IT
(EUCTR)
13/12/201127/04/2010RANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - NDRANDOMISED CONTROLLED TRIAL OF BOTULINUM TOXIN TYPE A AND B EFFICACY IN REDUCING DROOLING IN PARKINSON DISEASE - ND Parkinson disease
MedDRA version: 9.1;Level: LLT;Classification code 10013363
Trade Name: BOTOX
INN or Proposed INN: Botulinum toxin
Trade Name: NEUROBLOC
INN or Proposed INN: Botulinum toxin
AZIENDA OSPEDALIERO UNIVERSITARIA OSPEDALI RIUNITI UMBERTO I - G.M.LANCISI - G.SALESINULLNot RecruitingFemale: yes
Male: yes
Italy
849EUCTR2011-002901-31-CZ
(EUCTR)
12/12/201110/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
850NCT01479530
(ClinicalTrials.gov)
December 201122/11/2011Azilect® (Rasagiline) in Levodopa-treated Parkinson's Patients With Motor Fluctuations in ChinaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in ChinaParkinson's DiseaseDrug: Placebo;Drug: Azilect®H. Lundbeck A/SNULLCompleted30 YearsN/AAll321Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
851NCT01519271
(ClinicalTrials.gov)
December 201110/1/2012Mild Cognitive Impairment in Parkinson's DiseaseA Phase IV Randomized, Double-Blind, Placebo-Controlled, Crossover Single Site Study Of Exelon® Patch (Rivastigmine Transdermal System) For Mild Cognitive Impairment In Parkinson's DiseaseParkinson's Disease;Mild Cognitive ImpairmentDrug: Exelon Patch (rivastigmine transdermal system);Drug: Placebo PatchesUniversity of PennsylvaniaNULLCompleted40 Years85 YearsAll28Phase 4United States
852NCT02302144
(ClinicalTrials.gov)
December 201124/11/2014A Multifactorial Exercise Program to Reduce Falls in People With Parkinson DiseaseA Multifactorial Exercise Program to Reduce Falls in People With Parkinson DiseaseParkinson DiseaseBehavioral: Balance & Strengthening ExercisesBoston University Charles River CampusNULLCompleted18 YearsN/AAll32N/AUnited States
853NCT01351168
(ClinicalTrials.gov)
December 20119/5/2011Use of Zolpidem in Parkinson's DiseaseA Randomized, Controlled, Double-Blind, Cross-over Study of Zolpidem for Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Levodopa;Drug: Zolpidem first dose;Drug: Zolpidem second dose;Drug: sugar pillRush University Medical CenterNULLWithdrawn30 Years75 YearsBoth0Phase 2United States
854NCT01521117
(ClinicalTrials.gov)
December 201112/1/2012The Effect of Donepezil on Gait and Balance in Parkinson's DiseaseA Randomized, Double-blind, Placebo Controlled, Crossover Study to Evaluate the Effect of Donepezil on Gait and Balance in Parkinson's DiseaseParkinson's DiseaseDrug: DonepezilOregon Health and Science UniversityNULLRecruitingN/AN/ABoth12Phase 4United States
855EUCTR2011-002901-31-ES
(EUCTR)
30/11/201105/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Hungary;Czech Republic;Germany;United Kingdom;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
856EUCTR2011-002901-31-GB
(EUCTR)
25/11/201121/09/2011A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated painA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: Oxycodone hydrochloride
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Hungary;Czech Republic;Spain;Germany;United Kingdom
857EUCTR2009-015162-57-NL
(EUCTR)
21/11/201111/05/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme corp.NULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
858EUCTR2011-002073-30-IT
(EUCTR)
14/11/201106/03/2012Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson's disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10043118;Term: Tardive dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
63United States;European Union;Canada;Spain;Germany;Switzerland;Italy
859EUCTR2009-015162-57-PT
(EUCTR)
04/11/201112/08/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
860NCT01385592
(ClinicalTrials.gov)
November 201128/6/2011Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian DisordersDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years80 YearsBoth78Phase 2United States;Canada;France;Germany;Hungary;Italy;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
861NCT01556100
(ClinicalTrials.gov)
November 20116/3/2012Long-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease ProgressionLong-Term Vesicular Monoamine Transporter II Imaging and Clinical Assessment of Parkinson's Disease ProgressionParkinson DiseaseDrug: 18F-DTBZ AV-133Chang Gung Memorial HospitalNULLCompleted20 YearsN/AAll40Phase 2NULL
862NCT01291537
(ClinicalTrials.gov)
November 20117/2/2011Clinical and Economic Impact of Duodopa: Long-term Effectiveness Study in Advanced Parkinson's Disease PatientsParkinson's DiseaseDrug: Duodopa;Drug: best médical treatmentPoitiers University HospitalNULLCompleted18 Years80 YearsBoth56Phase 2France
863NCT01457807
(ClinicalTrials.gov)
November 201110/10/2011To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersA Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female VolunteersParkinson's DiseaseDrug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AstraZenecaNULLCompleted30 Years65 YearsBoth24Phase 1United Kingdom
864EUCTR2009-015162-57-PL
(EUCTR)
25/10/201130/08/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
865JPRN-JapicCTI-111673
12/10/201125/10/2011Phase II clinical study in patients with Parkinson's disease.Pharmacokinetic study of HP-3000 in patients with Parkinson's disease. Parkinson's diseaseIntervention name : HP-3000 (ropinirole hydrochloride patch)
Dosage And administration of the intervention : Transdermal, once daily
Hisamitsu Pharmaceutical Co., Inc.NULL2079BOTHPhase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
866EUCTR2011-000056-42-GB
(EUCTR)
07/10/201111/08/2011Sleep efficiency assessed by Polysomnography (PSG sleep lab testing) in advanced Parkinson's diseaseA MULTI-CENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECTS OF ROTIGOTINE ON SLEEP EFFICIENCY IN PATIENTS WITH ADVANCED PARKINSON’S DISEASE - sleep efficiency assessed by polysomnography in advanced Parkinson's Disease Advanced Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Celltech, UK - Registered Branch of UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
United Kingdom
867JPRN-UMIN000006521
2011/10/0111/10/2011Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's diseaseSwitch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole Parkinson's diseaseRapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks.Department of Neurology, Juntendo UniversityNULLRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
868NCT01439100
(ClinicalTrials.gov)
October 201121/9/2011A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated PainParkinson's Disease With Severe PainDrug: Oxycodone/Naloxone Prolonged Release tablets;Drug: PlaceboMundipharma Research GmbH & Co KGNULLCompleted25 YearsN/ABoth172Phase 3Czech Republic;Germany;Hungary;Poland;Romania;Spain;United Kingdom
869NCT01446614
(ClinicalTrials.gov)
October 20114/10/2011Mesenchymal Stem Cells Transplantation to Patients With Parkinson's DiseasePhase?/?Trial of Autologous Bone Marrow Derived Mesenchymal Stem Cells to Patients With Parkinson's Disease.Parkinson's DiseaseBiological: bone marrow derived mesenchymal stem cellsGuangzhou General Hospital of Guangzhou Military CommandNULLRecruiting30 Years65 YearsBoth20Phase 1;Phase 2China
870NCT01385735
(ClinicalTrials.gov)
October 201128/6/2011Emotion, Mood and Executive Function in Parkinson`s Disease (PD)Effects of Azilect (Rasagiline) on Processing of Emotions, Mood and Executive Function in Parkinson`s DiseaseParkinson DiseaseDrug: Rasagiline;Drug: PlaceboSt. Josef Hospital BochumNULLNot yet recruiting30 Years75 YearsBoth70Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
871NCT02427646
(ClinicalTrials.gov)
October 201122/4/2015Kinematic-guided BoNT-A Treatment for ET and PD TremorUse of Kinematic Assessment of Hand Tremor Pre- and Post- Treatment With Botulinum Toxin Type A in Essential Tremor and Parkinson DiseaseTremorDrug: BoNT-AWestern University, CanadaNULLActive, not recruiting18 Years80 YearsAll54Phase 2NULL
872EUCTR2010-018534-44-CZ
(EUCTR)
23/09/201104/07/2011Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD Early-Stage Parkinson’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Phytopharm plcNULLNot RecruitingFemale: yes
Male: yes
408Phase 2United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
873EUCTR2009-015162-57-IT
(EUCTR)
22/09/201127/04/2011A Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - NDA Phase 3, 40-week. Active-controlled, Double-blind, Double-Dummy Extension Study of Preladenant in Subjects with moderate to severe Parkinson`s Disease. - ND Parkinson`s disease
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Preladenant
Product Code: SCH420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
INN or Proposed INN: Rasagiline
Schering-Plough Research Institute, division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Lithuania;Bulgaria;Netherlands;Latvia;United Kingdom;Italy;Sweden
874EUCTR2011-000612-26-IT
(EUCTR)
19/09/201105/03/2012Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARKOpen-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK Syndrome Gilles de la Tourette's disease Parkinosn Pounding
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: PROSCAR*30CPR RIV 5MG
INN or Proposed INN: Finasteride
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
875NCT01474421
(ClinicalTrials.gov)
September 15, 20115/10/2011Safety and Efficacy of AQW051 in L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseA Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy, Safety and Tolerability of AQW051 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Moderate to Severe L-dopa Induced DyskinesiasDyskinesias;Drug-inducedDrug: AQW051;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll71Phase 2United States;France;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
876EUCTR2011-001148-31-GB
(EUCTR)
13/09/201117/08/2011A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1A pilot clinical trial with the iron chelator Deferiprone in Parkinson's disease - Pilot clinical trial iron chelator Deferiprone in Parkinson's Vs1 Parkinson's diseaseImperial College LondonNULLNot Recruiting Female: yes
Male: yes
48Phase 2United Kingdom
877NCT01515774
(ClinicalTrials.gov)
September 201110/1/2012Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson DiseaseParkinson's DiseaseDrug: Mirapex ERSeoul National University HospitalNULLRecruiting30 Years80 YearsBoth200Phase 4Korea, Republic of
878NCT02170376
(ClinicalTrials.gov)
September 201119/6/2014The Effect of BIA 9-1067 at Steady-state on the Levodopa PharmacokineticsThe Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopaBial - Portela C S.A.NULLCompleted18 Years45 YearsAll80Phase 1France
879NCT01461083
(ClinicalTrials.gov)
September 201127/9/2011Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1aPhase I Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a in Subjects With Parkinson Disease and Healthy SubjectsParkinson DiseaseDrug: [18F]MPPFInstitute for Neurodegenerative DisordersNULLCompleted18 Years90 YearsBoth19Phase 1United States
880NCT01545856
(ClinicalTrials.gov)
September 20112/2/2012Cardiovascular Events in Parkinson's Disease PatientsBackground Incidence of Cardiovascular Ischaemic Events in Treated Parkinson's Disease Patients in the Impact DatabaseCardiovascular Event;Parkinson DiseaseDrug: levodopaGlaxoSmithKlineNULLCompleted20 YearsN/AAll1N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
881EUCTR2010-020299-42-DE
(EUCTR)
30/08/201126/04/2011A study in U.S. and Germany to show if patients with an early stage of Parkinson's disease could be treated with a nicotine patch. In this study the nicotine patch is being compared to a placebo patch. The placebo patch is identical in appearance to the nicotine patch but does not contain any active ingredients.A randomized, placebo-controlled, double-blind, multi-center trial to assess the disease-modifying potential of transdermal nicotine in early Parkinson's disease in Germany and the USA (NIC-PD) - NIC-PD Early PD subjects within 18 months of diagnosis and not expected to require dopamine agonist or levodopa therapy for 1 year, with Hoehn and Yahr stage <2, with stable (>2 months) MAO-B inhibitor therapy allowed
MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Nicotinell 17,5 mg/24-Stunden-Pflaster
Product Name: Nicotinell
Other descriptive name: NICOTINE
Trade Name: Nicotinell 35 mg/24-Stunden-Pflaster
Product Name: Nicotinell
Other descriptive name: NICOTINE
Philipps-University MarburgNULLNot RecruitingFemale: yes
Male: yes
160Phase 2United States;Germany
882EUCTR2010-018534-44-HU
(EUCTR)
30/08/201108/07/2011Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD Early-Stage Parkinson’s Disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Phytopharm plcNULLNot RecruitingFemale: yes
Male: yes
408Phase 2France;United States;Serbia;Czech Republic;Hungary;Canada;Poland;Romania;Germany;United Kingdom
883EUCTR2009-015162-57-GB
(EUCTR)
16/08/201126/01/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
884EUCTR2009-015162-57-BG
(EUCTR)
04/08/201109/06/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
885EUCTR2010-021394-37-BG
(EUCTR)
04/08/201102/06/2011Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
886EUCTR2010-021860-13-BG
(EUCTR)
04/08/201102/06/2011EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
887NCT01437189
(ClinicalTrials.gov)
August 201116/9/2011The Effects of Sertraline on Depression in Parkinson's DiseaseClinical Protocol of Self-Controlled Study on the Effects of Sertraline on Depression in Parkinson's DiseaseDepression;Parkinson's DiseaseDrug: SertralineZhejiang UniversityNULLRecruiting35 Years75 YearsBoth35N/AChina
888NCT01370811
(ClinicalTrials.gov)
August 20118/6/2011A Relative Efficacy and Safety Study of OC Oral Solution for Sialorrhoea in Patients With Parkinson's DiseaseA Phase II, Double-blind, Randomized, Placebo-controlled 4-way Crossover Study to Evaluate the Relative Efficacy and Safety of OC Oral Solution (Oxybutynin and Clonidine) for Sialorrhoea in Patients With Parkinson's DiseaseSialorrhoeaDrug: OC oral solution treatment A;Drug: OC oral solution treatment B;Drug: OC oral solution treatment C;Drug: OC oral solution treatment DOrient Pharma Co., Ltd.NULLCompleted40 Years80 YearsBoth24Phase 2United States
889NCT01461109
(ClinicalTrials.gov)
August 201127/9/2011Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy ControlsEvaluation of [18F] CFPyPB PET as a Marker of Glycine Transporter-1 (GlyT1) Receptor in Subjects With Parkinson Disease, Alzheimer Disease and Healthy SubjectsParkinson Disease;Alzheimer DiseaseDrug: [18F] CFPyPBInstitute for Neurodegenerative DisordersNULLCompleted18 Years90 YearsBoth4Phase 1United States
890NCT01634568
(ClinicalTrials.gov)
August 201120/6/2012A Clinical Trial to Find Out V81444's Side Effects and Blood Levels in Healthy MenA Double-blind, Randomised, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Oral Doses of V81444 in Healthy Male VolunteersParkinson's DiseaseDrug: V81444Vernalis (R&D) LtdNULLCompleted18 Years45 YearsMale49Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
891EUCTR2010-021860-13-IT
(EUCTR)
25/07/201129/03/2012EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF` PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON`S DISEASE PATIENTS WITH `WEARING-OFF`PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson`s Disease (PD) and end-of-dose motor fluctuations
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: NA
Other descriptive name: NA
Trade Name: Comtan®
INN or Proposed INN: NA
BIAL - PORTELA & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Slovakia;Spain;Lithuania;Austria;Russian Federation;Italy;Hungary;Czech Republic;Romania;Croatia;Bulgaria;Latvia;Germany;Bosnia and Herzegovina
892EUCTR2009-015162-57-LT
(EUCTR)
25/07/201121/04/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
893EUCTR2009-015162-57-LV
(EUCTR)
19/07/201111/05/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153 AM1)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Serbia;Portugal;United States;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
894EUCTR2009-015162-57-SE
(EUCTR)
12/07/201131/05/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
895NCT01397422
(ClinicalTrials.gov)
July 201118/7/2011Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Dyskinesia;Levodopa Induced Dyskinesia;Parkinson's DiseaseDrug: ADS-5102 (extended release amantadine HCl)Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll83Phase 2;Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
896EUCTR2010-020112-11-LT
(EUCTR)
29/06/201106/04/2011Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
585Phase 3United States;Serbia;Mexico;Argentina;Ukraine;Croatia;Lithuania;Chile;South Africa;Russian Federation;Latvia;Colombia
897EUCTR2011-001092-39-DE
(EUCTR)
29/06/201117/05/2011efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesiasA multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose study to assess the efficacy, safety and tolerability of AQW051 in reducing L-dopa induced dyskinesiasin Parkinson’s patients with moderate to severe L-dopa induced dyskinesias L-dopa induced dyskinesias in Parkinson’s patients with moderate to severe L-dopa induced dyskinesias
MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AQW051
Product Code: AQW051
Product Name: AQW051
Product Code: AQW051
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72France;United States;Germany;Italy
898EUCTR2010-021860-13-CZ
(EUCTR)
24/06/201109/11/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa L-DOPA/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
899EUCTR2010-022200-46-LV
(EUCTR)
21/06/201101/04/2011Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease.Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
900EUCTR2010-020112-11-LV
(EUCTR)
21/06/201108/04/2011Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12-Week, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P07037) - P07037 Parkinson's disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
585Phase 3United States;Serbia;Mexico;Argentina;Ukraine;Lithuania;Croatia;South Africa;Russian Federation;Chile;Colombia;Latvia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
901EUCTR2009-015162-57-CZ
(EUCTR)
17/06/201115/04/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
902EUCTR2009-013552-72-PL
(EUCTR)
08/06/201123/02/2011A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
903EUCTR2009-015161-31-PL
(EUCTR)
08/06/201123/02/2011A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
904NCT01652534
(ClinicalTrials.gov)
June 201115/8/2011Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's DiseaseEfficacy of Amantadine for Gait Dysfunction and Gait Freezing in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Amantadine;Drug: PlaceboNorthwestern UniversityNULLTerminated18 Years85 YearsAll3Phase 3United States
905NCT02253563
(ClinicalTrials.gov)
June 201124/9/2014Resistance Versus Balance Training in Parkinson's DiseaseResistance Training Versus Balance Training to Improve Postural Control in Patients With Parkinson's Disease - a Randomized Controlled Rater Blinded TrialParkinson's DiseaseBehavioral: Resistance Training;Behavioral: Balance TrainingUniversity of KielNULLCompleted40 Years100 YearsBoth40N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
906NCT01528592
(ClinicalTrials.gov)
June 201131/1/2012PharmacoMRI of Parkinson DiseaseA Pilot Study of the Drug Effects on Brain Connectivity of Parkinson's DiseaseParkinson's DiseaseDrug: Carbidopa-LevodopaNorthwestern UniversityNULLCompleted30 YearsN/AAll18N/AUnited States
907EUCTR2010-022517-25-DE
(EUCTR)
30/05/201114/02/2011Safety, tolerability and efficacy of ADX48621 in patients with Parkinson's diseasePhase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease Levodopa induced dyskinesia in Parkinson's disease patients
MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ADX48621
Product Code: ADX48621
INN or Proposed INN: Dipraglurant
Addex Pharma SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2United States;France;Austria;Germany
908EUCTR2008-005492-94-BG
(EUCTR)
25/05/201123/03/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
909EUCTR2009-015162-57-ES
(EUCTR)
23/05/201131/03/2011Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153)Estudio de extensión de fase 3, de 40 semanas, controlado con tratamiento activo, doble ciego y doble simulación del preladenant en sujetos con enfermedad de Parkinson de moderada a grave (fase 3; n. de protocolo P06153) Enfermedad de Parkinson
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Czech Republic;Poland;Bulgaria;Latvia;Netherlands;Sweden
910EUCTR2010-021394-37-AT
(EUCTR)
19/05/201105/01/2011Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
911EUCTR2010-022200-46-FI
(EUCTR)
13/05/201123/03/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Germany;Latvia;Lithuania
912EUCTR2010-022200-46-LT
(EUCTR)
09/05/201105/04/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
913EUCTR2007-002964-90-BE
(EUCTR)
05/05/201104/09/2007A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
605Phase 3United States;Estonia;Taiwan;Slovakia;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Belgium;Malaysia;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
914EUCTR2010-021394-37-SK
(EUCTR)
02/05/201116/12/2010Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
915NCT01520987
(ClinicalTrials.gov)
May 201126/1/2012Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian SubjectsRandomized, Double-Blinded, Placebo-Controlled, Multiple Ascending Dose Study to Compare the Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years65 YearsAll105Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
916NCT01361009
(ClinicalTrials.gov)
May 201123/5/2011a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease PatientsSafety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing SurveillanceParkinson DiseaseDrug: pramipexoleBoehringer IngelheimNULLCompleted30 Years75 YearsAll2017N/AChina
917NCT01364545
(ClinicalTrials.gov)
May 201118/5/2011Ketogenic Diets for Symptoms of Parkinson's DiseaseKetogenic Diets for Symptoms of Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Ketone ester drink;Dietary Supplement: Placebo (carbohydrate containing) drinkUniversity of OxfordNULLRecruiting42 YearsN/ABoth20N/AUnited Kingdom
918NCT01462708
(ClinicalTrials.gov)
May 20118/6/2011Evaluation of [18F]MK-9470 as a Brain Tracer of Cannabinoid-1 Receptor in Parkinson's Disease and Healthy SubjectsEvaluation of [18F] MK-9470 and PET as a Marker of Cannabinoid-1 Receptor Activity in Subjects With Parkinson Disease Compared With Healthy ControlsParkinson DiseaseDrug: [18F]MK-9470Institute for Neurodegenerative DisordersNULLCompleted18 Years90 YearsBoth16Phase 1United States
919NCT01766258
(ClinicalTrials.gov)
May 201122/11/2012Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor FluctuationsEfficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor FluctuationsParkinson's DiseaseDrug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: StalevoOrion Corporation, Orion PharmaNULLCompleted30 YearsN/ABoth117Phase 2NULL
920EUCTR2010-022366-27-CZ
(EUCTR)
21/04/201123/11/2010BIPARK STUDY IIEfficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II Idiopathic Parkinson's Disease
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
BIAL Portela & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
405Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
921EUCTR2010-022366-27-BE
(EUCTR)
18/04/201101/02/2011Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY IIEfficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II Idiopathic Parkinson's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
BIAL Portela & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
405Phase 3Czech Republic;Estonia;Belgium;United Kingdom
922EUCTR2010-022517-25-AT
(EUCTR)
15/04/201117/02/2011Phase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's diseasePhase 2, randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the safety, tolerability and efficacy of ADX48621 in the treatment of levodopa induced dyskinesia in patients with Parkinson's disease Levodopa induced dyskinesia in Parkinson's disease patients
MedDRA version: 14.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ADX48621
Product Code: ADX48621
INN or Proposed INN: Dipraglurant
Addex Pharma SANULLNot RecruitingFemale: yes
Male: yes
90Phase 2United States;France;Austria;Germany
923EUCTR2008-005492-94-PT
(EUCTR)
14/04/201119/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
924EUCTR2009-015161-31-DE
(EUCTR)
04/04/201124/08/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
925JPRN-UMIN000005403
2011/04/0108/04/2011A Multi-center Randomized Placebo-controlled Double-blinded Study for the Efficacy of Donepezil against Psychosis in Parkinson Disease Parkinson disease5mg of donepezil hydrochloride
placebo
Designated Research, National Hospital OrganizationNULLComplete: follow-up complete20years-old80years-oldMale and Female142Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
926NCT01336088
(ClinicalTrials.gov)
April 20114/4/2011ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's DiseasePhase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ADX48621;Drug: PlaceboAddex Pharma S.A.NULLCompleted30 Years75 YearsBoth83Phase 2United States;Austria;France;Germany
927NCT01662414
(ClinicalTrials.gov)
April 20117/8/2012Effect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's DiseaseEffect of Undenatured Cysteine-Rich Whey Protein Isolate (HMS 90®) in Patients With Parkinson's Disease: Changes in Biomarkers of Oxidative Stress, Profiles of Plasma Amino Acids and Their Derivatives and Brain FunctionParkinson Disease;Parkinsonian Disorders;Basal Ganglia Diseases;Brain Diseases;Central Nervous System Diseases;Nervous System Diseases;Movement Disorders;Neurodegenerative DiseasesDietary Supplement: Whey protein;Dietary Supplement: Soy proteinChulalongkorn UniversityNULLCompleted30 Years80 YearsBoth38Phase 4Thailand
928NCT01338896
(ClinicalTrials.gov)
April 201118/4/2011Study to Compare Adhesiveness of Two Different Rotigotine Patch FormulationsA Multicenter, Randomized, Double-blind, Two-way Cross-over Study to Compare the Adhesiveness of Two Different Rotigotine Patch Formulations in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine transdermal patchUCB PharmaNULLCompleted18 YearsN/ABoth56Phase 1Austria;Germany;United Kingdom
929NCT01313819
(ClinicalTrials.gov)
April 201110/3/2011The Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic TherapyA Double Blind, Placebo-controlled Study for the Effect of IV Amantadine on Freezing of Gait (FOG) Resistant to Dopaminergic TherapyParkinson`s Disease;Freezing of GaitDrug: PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml injSeoul National University HospitalNULLRecruiting30 Years80 YearsBoth20Phase 4Korea, Republic of
930NCT01937078
(ClinicalTrials.gov)
April 201126/7/2012Famotidine for Levodopa-induced Dyskinesia in PDAn 'N-of-1' Study of the Histamine H@ Antagonist, Famotidine in Levodopa-induced Dyskinesia in Parkinson's DiseaseDyskinesiaDrug: FamotidineUniversity Health Network, TorontoNULLCompleted18 Years80 YearsBoth7Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
931NCT01323855
(ClinicalTrials.gov)
March 28, 201124/3/2011A Study to Assess Pharmacokinetics (PK) of Preladenant in Participants With Chronic Renal Impairment (CRI) (P06512)A Study to Assess Pharmacokinetics of Preladenant in Subjects With Chronic Renal ImpairmentParkinson DiseaseDrug: PreladenantMerck Sharp & Dohme Corp.NULLCompleted18 Years75 YearsAll46Phase 1Germany
932EUCTR2009-013552-72-BG
(EUCTR)
24/03/201126/01/2011A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
933EUCTR2010-022366-27-GB
(EUCTR)
23/03/201130/11/2010BIPARK STUDY IIEfficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II Idiopathic Parkinson's Disease
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
BIAL Portela & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
405Phase 3Estonia;Czech Republic;Argentina;Belgium;Australia;Israel;Chile;South Africa;Russian Federation;United Kingdom;Korea, Republic of;India
934EUCTR2009-015162-57-AT
(EUCTR)
17/03/201103/02/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
935EUCTR2008-005492-94-CZ
(EUCTR)
14/03/201103/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
936EUCTR2010-018534-44-DE
(EUCTR)
11/03/201110/08/2010Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD Early-Stage Parkinson’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Product Name: PYM50028
Product Code: PYM50028
INN or Proposed INN: SMILAGENIN
Other descriptive name: (3ß, 5ß, 25R)-spirostan-3-ol
Phytopharm plcNULLNot RecruitingFemale: yes
Male: yes
408Phase 2United States;Serbia;France;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
937EUCTR2010-021860-13-DE
(EUCTR)
09/03/201118/10/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Opicapone
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: Opicapone
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: Opicapone
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
938EUCTR2010-021394-37-CZ
(EUCTR)
09/03/201114/12/2010Placebo-controlled study in patients with Parkinson’s disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Hungary;Czech Republic;Spain;Belgium;Austria;Germany;Italy;Switzerland
939EUCTR2010-021394-37-DE
(EUCTR)
08/03/201103/12/2010Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
940EUCTR2009-013552-72-GB
(EUCTR)
07/03/201107/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
941EUCTR2009-015161-31-GB
(EUCTR)
07/03/201101/07/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
942EUCTR2008-005492-94-FI
(EUCTR)
04/03/201113/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
943EUCTR2009-015162-57-FI
(EUCTR)
02/03/201120/01/2011An Active-Controlled Extension Study to P04938 and P07037 (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3, Protocol No. P06153) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3United States;Serbia;Portugal;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Peru;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;Sweden
944EUCTR2010-021394-37-IT
(EUCTR)
01/03/201128/12/2011STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976STUDIO MULTICENTRICO, IN DOPPIO CIECO, CONTROLLATO VERSO PLACEBO, A GRUPPI PARALLELI, DI FASE IV VOLTO A VALUTARE GLI EFFETTI DELLA ROTIGOTINA NEI SINTOMI NON MOTORI IN SOGGETTI CON MALATTIA IDIOPATICA DI PARKINSON - SP0976 subjects with Parkinson’s disease.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: NEUPRO
INN or Proposed INN: Rotigotine
Trade Name: NEUPRO
INN or Proposed INN: Rotigotine
Trade Name: NEUPRO
INN or Proposed INN: Rotigotine
Trade Name: NEUPRO
INN or Proposed INN: Rotigotine
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy
945NCT01568073
(ClinicalTrials.gov)
March 201129/3/2012Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off PhenomenonEfficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo- and Active-controlled, Parallel-group, Multicentre Clinical StudyParkinson's DiseaseDrug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: BenserazideBial - Portela C S.A.NULLCompleted30 Years83 YearsAll600Phase 3Portugal;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
946NCT01330290
(ClinicalTrials.gov)
March 201118/3/2011Caregivers' and Physicians' Treatment Preference in Parkinson Patients Treated With Neupro® Requiring Caregiver SupportA Multi-site, Non-interventional, Cross-sectional Evaluation of the Caregivers' and the Physicians' Preferred Route of Administration and the Physicians' Rationale for the Choice of Neupro® in Patients With Parkinson Requiring Caregiver SupportIdiopathic Parkinson's DiseaseDrug: Neupro®UCB PharmaNULLCompleted18 YearsN/AAll148N/AGermany
947NCT01227655
(ClinicalTrials.gov)
March 201122/10/2010Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With Wearing-off Phenomenon Treated With Levodopa Plus a Dopa Decarboxylase Inhibitor (DDCI): a Double-blind, Randomised, Placebo-controlled, Parallel-group, Multicentre Clinical Study.Parkinson's DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: Levodopa;Drug: Carbidopa;Drug: BenserazideBial - Portela C S.A.NULLCompleted30 Years83 YearsAll427Phase 3Portugal
948NCT02169427
(ClinicalTrials.gov)
March 201124/1/2012An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and MetabolitesAn Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral AdministrationParkinson's Disease (PD)Drug: OPCBial - Portela C S.A.NULLCompleted18 Years55 YearsMale6Phase 1Netherlands
949NCT01341431
(ClinicalTrials.gov)
March 201130/3/2011Bee Venom for the Treatment of Parkinson DiseaseEvaluation of the Symptomatic and Neuroprotective Effects of Bee Venom for the Treatment of Parkinson DiseaseParkinson DiseaseDrug: bee venomAssistance Publique - Hôpitaux de ParisNULLCompleted40 YearsN/ABoth50Phase 2France
950NCT01283594
(ClinicalTrials.gov)
March 201124/1/2011Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing OffA Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of SYN115 as Adjunctive Therapy in Levodopa-treated Parkinson's Subjects With End of Dose Wearing OffParkinson's DiseaseDrug: Tozadenant (SYN115) 60 mg BID;Drug: Placebo;Drug: Levodopa (L-dopa);Drug: Tozadenant (SYN115) 120 mg BID;Drug: Tozadenant (SYN115) 180 mg BID;Drug: Tozadenant (SYN115) 240 mg BIDBiotie Therapies Inc.NULLCompleted30 Years80 YearsAll420Phase 2;Phase 3United States;Argentina;Canada;Chile;Romania;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
951NCT01264861
(ClinicalTrials.gov)
March 201120/12/2010A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain ImagingOpen-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease PatientsParkinson DiseaseDrug: SafinamideNewronNULLTerminated40 Years80 YearsAll5Phase 2United States
952NCT01294800
(ClinicalTrials.gov)
February 25, 201110/2/2011A Dose Finding Study of Preladenant (SCH 420814) for the Treatment of Parkinson's Disease (PD) in Japanese Patients (P06402)A Phase 2, 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Preladenant in Japanese Subjects With Moderate to Severe Parkinson's Disease. (Phase 2; Protocol No. P06402)Parkinson's DiseaseDrug: Preladenant;Drug: Placebo tablet to match PreladenantMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll450Phase 2Japan
953EUCTR2008-001329-33-GB
(EUCTR)
24/02/201115/03/2010Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie IncNULLNot Recruiting Female: yes
Male: yes
275Phase 3Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom
954EUCTR2010-022363-35-DE
(EUCTR)
18/02/201119/10/2010Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Madopar LT
Product Name: Levodopa / Benserazid
Product Code: LD / BE
INN or Proposed INN: LEVODOPA
Other descriptive name: -
INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE
Other descriptive name: -
Trade Name: Neupro
Product Name: Rotigotin
Product Code: RO
INN or Proposed INN: ROTIGOTINE
Other descriptive name: -
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
955EUCTR2009-015161-31-BG
(EUCTR)
17/02/201102/02/2011A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
750Phase 3Portugal;United States;Finland;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
956EUCTR2010-021860-13-SK
(EUCTR)
17/02/201109/12/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Netherlands;Germany;Latvia;Bosnia and Herzegovina
957EUCTR2010-021394-37-ES
(EUCTR)
17/02/201122/12/2010Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos, fase IV para evaluar el efecto de rotigotina sobre los síntomas no motores en pacientes con enfermedad de Parkinson idiopática(Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinsons disease) - SP0976 Enfermedad de Parkinson
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: NEUPRO 2 mg/24 h parche transdérmico
INN or Proposed INN: ROTIGOTINA
Other descriptive name: ROTIGOTINE
Trade Name: NEUPRO 4 mg/24 h parche transdérmico
INN or Proposed INN: ROTIGOTINA
Other descriptive name: ROTIGOTINE
Trade Name: NEUPRO 6 mg/24 h parche transdérmico
INN or Proposed INN: ROTIGOTINA
Other descriptive name: ROTIGOTINE
Trade Name: NEUPRO 8 mg/24 h parche transdérmico
INN or Proposed INN: ROTIGOTINA
Other descriptive name: ROTIGOTINE
UCB Pharma SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
345Phase 4Hungary;Czech Republic;Germany;Belgium;Spain;Italy;Austria
958EUCTR2010-021394-37-HU
(EUCTR)
14/02/201113/12/2010Multicenter, double-blind, placebo controlled, parallel-group, phase IV study to assess the effect of rotigotine on non-motor symptoms in patients with idiopathic parkinson’s diseaseMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Spain;Belgium;Austria;Germany;Italy;Switzerland
959EUCTR2009-017174-20-AT
(EUCTR)
09/02/201107/12/2010A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study Idiopathic Parkinson's disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015E, EMD 1195686, MSC2191632B
INN or Proposed INN: safinamide
Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
24Germany;Canada;France;Austria;South Africa
960NCT01296464
(ClinicalTrials.gov)
February 201114/2/2011Comparing Different Levodopa/Carbidopa/Entacapone Treatment RegimensDuration of Motor Response After Administration of Experimental Levodopa/Carbidopa/Entacapone Treatment Regimens Compared to Standard Treatment (Stalevo®);a Randomised,Double-blind,Crossover,Multicentre,Single Dose Study in Patients With Parkinson?s Disease and Wearing-off SymptomsParkinson's DiseaseDrug: CarbidopaOrion Corporation, Orion PharmaNULLCompleted30 YearsN/ABoth27Phase 2Finland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
961NCT01300819
(ClinicalTrials.gov)
February 201118/2/2011Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor SymptomsMulticenter, Double-blind, Placebo-controlled, Parallel-group, Phase IV Study to Assess the Effect of Rotigotine on Non-motor Symptoms in Patients With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseOther: Placebo;Drug: RotigotineUCB PharmaNULLCompleted18 YearsN/AAll349Phase 4Austria;Belgium;Bulgaria;Czech Republic;France;Germany;Hungary;Italy;Romania;Slovakia;Spain;Switzerland
962NCT02880033
(ClinicalTrials.gov)
February 20113/8/2016Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating LymphocytesModulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral SclerosisParkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron OverloadDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted18 Years80 YearsAll90N/AFrance
963EUCTR2009-015161-31-PT
(EUCTR)
28/01/201129/10/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., IncNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
964EUCTR2010-021860-13-RO
(EUCTR)
27/01/201125/07/2011EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Portugal;Hungary;Germany;Netherlands;Bulgaria;France;Montenegro;Italy;Latvia;Austria;Lithuania;Slovakia;Russian Federation;Czech Republic;Ukraine;Serbia;Romania;Spain;Bosnia and Herzegovina;Croatia;Poland
965EUCTR2010-021860-13-AT
(EUCTR)
27/01/201111/10/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Czech Republic;Hungary;Poland;Romania;Croatia;Bulgaria;Germany;Latvia;Netherlands;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
966EUCTR2010-021394-37-BE
(EUCTR)
25/01/201114/12/2010Placebo-controlled study in patients with Parkinson's disease to evaluate the effect of rotigotine on nonmotor symptomsMULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL-GROUP, PHASE IV STUDY TO ASSESS THE EFFECT OF ROTIGOTINE ON NON-MOTOR SYMPTOMS IN PATIENTS WITH IDIOPATHIC PARKINSON’S DISEASE - SP0976 Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neupro 2mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 4mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 6mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
Trade Name: Neupro 8mg/24h transdermal patch
INN or Proposed INN: ROTIGOTINE
UCB Pharma SANULLNot RecruitingFemale: yes
Male: yes
345Phase 4Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Bulgaria;Germany;Italy;Switzerland
967EUCTR2010-021860-13-ES
(EUCTR)
24/01/201127/10/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY IEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON'S DISEASE PATIENTS WITH 'WEARING-OFF' PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY.EFICACIA Y SEGURIDAD DE BIA 9-1067 EN PACIENTES CON ENFERMEDAD DE PARKINSON IDIOPÁTICA CON FENÓMENO DE 'WEARING OFF' TRATADOS CON LEVODOPA Y UN INHIBIDOR DE DOPA DESCAROBOXILASA (IDDC): ENSAYO CLÍNICO MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO CON PLACEBO Y ACTIVO, DE GRUPOS PARALELOS - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson's disease (PD) and end-of-dose motor fluctuations.Adjunto a levodopa/inhibidor dopa descarboxilasa para pacientes con enfermedad de Parkinson y fluctuaciones motoras de fin de dosis
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
968EUCTR2009-015161-31-CZ
(EUCTR)
17/01/201128/07/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
969EUCTR2009-013552-72-CZ
(EUCTR)
17/01/201128/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
970EUCTR2010-022915-21-SE
(EUCTR)
12/01/201118/11/2010Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTESTDuration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: carbidopa 20 mg
Product Code: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
Product Name: carbidopa 27.5 mg
Product Code: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
Trade Name: Stalevo 100/25/200 mg
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA
Other descriptive name: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
INN or Proposed INN: ENTACAPONE
Other descriptive name: NA
Trade Name: Stalevo 150/37.5/200 mg
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA
Other descriptive name: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
INN or Proposed INN: ENTACAPONE
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
27Finland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
971EUCTR2010-022915-21-FI
(EUCTR)
10/01/201111/11/2010Duration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTESTDuration of motor response after administration of experimental levodopa/carbidopa/entacapone treatment regimens compared to standard treatment (Stalevo®); a randomised, double-blind, crossover, multicentre, single dose study in patients with Parkinson’s disease and wearing-off symptoms - PARTEST Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: carbidopa 20 mg
Product Code: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
Product Name: carbidopa 27.5 mg
Product Code: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
Trade Name: Stalevo 100/25/200 mg
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA
Other descriptive name: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
INN or Proposed INN: ENTACAPONE
Other descriptive name: NA
Trade Name: Stalevo 150/37.5/200 mg
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA
Other descriptive name: NA
INN or Proposed INN: CARBIDOPA
Other descriptive name: NA
INN or Proposed INN: ENTACAPONE
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
27Finland;Sweden
972NCT01268891
(ClinicalTrials.gov)
January 201130/12/2010Study of Azilect® (Rasagiline) in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations in KoreaRandomised, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose Study of [Azilect®] Rasagiline in Levodopa-treated Parkinson's Patients With Motor Fluctuations in KoreaParkinson's DiseaseDrug: Placebo;Drug: Azilect®H. Lundbeck A/SNULLCompleted30 YearsN/AAll132Phase 3Korea, Republic of
973NCT01489982
(ClinicalTrials.gov)
January 201119/7/2011Treatments for Insomnia in Patients With Parkinson's DiseaseTreatments for Insomnia in Patients With Parkinson's Disease: A Pilot StudyParkinson's Disease;InsomniaDevice: Light box (Litebook company);Behavioral: CBT and sleep hygiene;Drug: Doxepin and Zopiclone;Device: Light box ( Litebook company)McGill University Health CenterNULLCompleted18 YearsN/ABoth20Phase 0Canada
974NCT01229332
(ClinicalTrials.gov)
January 20113/10/2010A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease PatientsA Phase I/II, Single-center, Randomized, Cross-over, Double-blind, Placebo-controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Administration of Subcutaneous Continuously-delivered Carbidopa Solution (ND0611) on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Levodopa-treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: Saline;Drug: CarbidopaNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth24Phase 1;Phase 2Israel
975NCT01301573
(ClinicalTrials.gov)
January 201118/2/2011Long Term Follow-Up Study for rAAV-GAD Treated SubjectsParkinson's DiseaseBiological: rAAV-GADNeurologix, Inc.NULLTerminated30 Years90 YearsBoth40N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
976NCT01341080
(ClinicalTrials.gov)
December 28, 201021/4/2011Varenicline for Gait and Balance Impairment in Parkinson DiseaseVarenicline for the Treatment of Postural and Gait Dysfunction in Parkinson DiseaseParkinson DiseaseDrug: Varenicline;Drug: Sugar pillRush University Medical CenterNULLCompleted40 Years90 YearsAll40Phase 2United States
977EUCTR2010-021860-13-PT
(EUCTR)
22/12/201008/11/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Serbia;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Romania;Croatia;Bulgaria;Netherlands;Latvia;Germany;Bosnia and Herzegovina
978EUCTR2010-021860-13-LV
(EUCTR)
22/12/201014/10/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY IEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
979EUCTR2008-004146-88-DE
(EUCTR)
20/12/201015/10/2010An extension trial to investigate the long-term efficacy and safety of safinamide, as an add-on-therapy in patients with early Parkinson´s disease treated with a stable dose of a dopamine agonistA phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;United States;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
980EUCTR2010-022366-27-EE
(EUCTR)
10/12/201003/11/2010Efficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY IIEfficacy and safety of BIA 9-1067 in idiopathic Parkinson’s disease patients with wearing-off” phenomenon treated with levodopa plus a dopa decarboxylase inhibitor (DDCI): a double-blind, randomised, placebo-controlled, parallel-group, multicentre clinical study. - BIPARK STUDY II Idiopathic Parkinson's Disease
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: Not yet available
Other descriptive name: 2,5-Dichloro-3-(5-(3,4-dihydroxy-5-nitrophenyl)-1,2,4-oxadiazol-3-yl)-4,6-dimethylpyridine-1-oxide
BIAL Portela & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
405Czech Republic;Estonia;Belgium;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
981EUCTR2009-015161-31-NL
(EUCTR)
09/12/201009/08/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Netherlands;Germany;Sweden;United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India
982EUCTR2009-015161-31-IT
(EUCTR)
06/12/201028/09/2010 A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND A Phase 3, 12-Week, Double-Blind, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson’s Disease. (Phase 3; Protocol No. P04938) - ND Parkinson`s Disease
MedDRA version: 9.1;Level: PT;Classification code 10061536
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Finland;Spain;Austria;Italy;United Kingdom;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
983EUCTR2009-013552-72-IT
(EUCTR)
06/12/201004/11/2010A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - NDA Phase 3, Double-Blind, Placebo- and Active-Controlled Dose- Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - ND Parkinson`s Disease
MedDRA version: 9.1;Level: PT;Classification code 10061536
Product Name: Preladenant
Product Code: SCH420814
Product Name: Preladenant
Product Code: SCH420814
Product Name: Preladenant
Product Code: SCH420814
Trade Name: Azilect
INN or Proposed INN: Rasagiline
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;United Kingdom;Italy;Sweden
984EUCTR2009-013552-72-SE
(EUCTR)
02/12/201006/10/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
985EUCTR2009-015161-31-SE
(EUCTR)
02/12/201006/10/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
986EUCTR2010-021860-13-LT
(EUCTR)
30/11/201028/09/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDYEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I
MedDRA version: 16.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Serbia;Portugal;Slovakia;Spain;Ukraine;Lithuania;Austria;Russian Federation;Montenegro;Italy;France;Hungary;Czech Republic;Poland;Croatia;Romania;Bulgaria;Latvia;Germany;Netherlands;Bosnia and Herzegovina
987EUCTR2010-020109-34-ES
(EUCTR)
29/11/201023/09/2010Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment.Estudio Fase II, doble ciego, aleatorizado, controlado con placebo, de grupos paralelos, para explorar los posibles efectos beneficiosos de safinamida en la cognición, en pacientes no dementes con enfermedad de Parkinson (EP) idiopática y deterioro cognitivo.A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson's disease (PD) and cognitive impairment. Cognition in non-demented patients with idiopathic Parkinson's disease Cognición en sujetos no dementes con Enfermedad de Parkinson idiopática
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamida
Product Code: NW-1015
Other descriptive name: Safinamida
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain;Italy
988EUCTR2010-020109-34-IT
(EUCTR)
24/11/201027/12/2010A double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - NDA double-blind, randomized, placebo-controlled, parallel-group Phase II study to explore the potential beneficial effects of safinamide on cognition in non-demented patients with idiopathic Parkinson’s disease (PD) and cognitive impairment. - ND Cognition in non-demented patients with idiopathic Parkinson’s disease
MedDRA version: 9.1;Level: PT;Classification code 10061536
Product Name: SAFINAMIDE
Product Code: NW-1015
MERCK SERONO SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Spain;Italy
989NCT01227265
(ClinicalTrials.gov)
November 19, 201022/10/2010Placebo Controlled Study of Preladenant in Participants With Moderate to Severe Parkinson's Disease (P07037)A Phase 3, 12 Week, Double-blind, Placebo-controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease.Parkinson Disease;Idiopathic Parkinson Disease;Idiopathic Parkinson's DiseaseDrug: Preladenant;Drug: PlaceboMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll476Phase 3Argentina;Chile;Colombia;Croatia;Latvia;Lithuania;Mexico;Russian Federation;Serbia;South Africa;Ukraine;United States
990NCT01215227
(ClinicalTrials.gov)
November 18, 20104/10/2010An Active-Controlled Extension Study to NCT01155466 [P04938] and NCT01227265 [P07037] (P06153)A Phase 3, 40-Week, Active-Controlled, Double-Blind, Double-Dummy Extension Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3, Protocol No. P06153)Parkinson Disease;Idiopathic Parkinson DiseaseDrug: Preladenant;Drug: Rasagiline;Drug: Placebo to preladenant;Drug: Placebo to rasagilineMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll839Phase 3Argentina;Austria;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;France;India;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;South Africa;Spain;Sweden;Ukraine;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
991EUCTR2010-021860-13-HU
(EUCTR)
11/11/201027/09/2010EFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY IEFFICACY AND SAFETY OF BIA 9-1067 IN IDIOPATHIC PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA PLUS A DOPA DECARBOXYLASE INHIBITOR (DDCI): A DOUBLE-BLIND, RANDOMISED, PLACEBO- AND ACTIVE-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL STUDY - BIPARK STUDY I Adjunct to levodopa (L-DOPA)/DDCI for use in patients with Parkinson’s disease (PD) and end-of-dose motor fluctuations.
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Trade Name: Comtan®
Product Name: Over-encapsulated Entacapone Tablets
Product Code: Over-encapsulated Entacapone Tablets
INN or Proposed INN: ENTACAPONE
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
INN or Proposed INN: BIA 9-1067
Other descriptive name: BIA 9-1067
BIAL - Portela & Ca, S.A.NULLNot RecruitingFemale: yes
Male: yes
550Portugal;Czech Republic;Hungary;Slovakia;Spain;Romania;Lithuania;Austria;Bulgaria;Germany;Latvia;Italy
992EUCTR2007-001109-26-GB
(EUCTR)
04/11/201005/08/2010A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s diseaseA phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease Patients with bilateral, idiopathic Parkinson's DiseaseOxford BioMedica (UK) LtdNULLNot Recruiting Female: yes
Male: yes
27Phase 1;Phase 2United Kingdom
993EUCTR2009-015161-31-AT
(EUCTR)
03/11/201017/08/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
994NCT01060878
(ClinicalTrials.gov)
November 20101/2/2010Investigation of Cogane (PYM50028) in Early-stage Parkinson's Disease (CONFIDENT-PD)Phase II, Randomised, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of PYM50028 in Subjects With Early-stage Parkinson's Disease Administered Once Daily for 28 WeeksParkinson's DiseaseDrug: PYM50028;Drug: PlaceboPhytopharmNULLCompleted35 Years75 YearsBoth425Phase 2United States;Canada;Czech Republic;France;Germany;Hungary;Poland;Romania;Serbia;United Kingdom
995NCT01190553
(ClinicalTrials.gov)
November 201026/8/2010Pilot Study of Maintenance Therapy With Intravenous AMANTADINEMaintenance Therapy of Intravenous Amantadine in Patients With Idiopathic Parkinson Disease Who Are Not Optimally Treated With Anti Parkinson MedicationsParkinson DiseaseDrug: AmantadineRabin Medical CenterNULLNot yet recruiting30 Years80 YearsBoth20N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
996NCT01270711
(ClinicalTrials.gov)
November 20109/12/2010Study On Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)Study on Utilization Of Cabergoline For Compliance With Risk Minimization Activities (SUCRE)Parkinson's Disease;HyperprolactinemiaDrug: Study DrugPfizerNULLCompletedN/AN/AAll22014N/ANULL
997EUCTR2009-013552-72-ES
(EUCTR)
26/10/201027/07/2010Estudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSEEstudio de eficacia y seguridad de fase 3, doble ciego, de doble simulación, controlado con placebo y tratamiento activo, de búsqueda del intervalo de dosis del preladenant en sujetos con enfermedad de Parkinson inicial (Fase 3 N.º de protocolo P05664) - PARADYSE Enfermendad de Parkinson
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Schering Corporation, división Schering-Plough ResearchNULLNot Recruiting Female: yes
Male: yes
1000Phase 3Hungary;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
998EUCTR2010-018534-44-GB
(EUCTR)
22/10/201009/08/2010Investigation of Cogane (PYM50028) in early stage Parkinson's diseaseA Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group study to investigate the efficacy, safety and tolerability of Cogane™ (PYM50028), a novel, orally active neurotrophic factor inducer, in male and female subjects with early-stage Parkinson’s disease when administered once daily for 28 weeks - CONFIDENT-PD Early-Stage Parkinson’s Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Phytopharm plcNULLNot Recruiting Female: yes
Male: yes
408Phase 2France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Romania;Germany;United Kingdom
999EUCTR2009-013552-72-HU
(EUCTR)
21/10/201011/08/2010A Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - MonotherapyA Phase 3, Double-Blind, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's Disease - PARADYSE - Monotherapy Parkinson's diseaseProduct Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3Czech Republic;Hungary;Finland;Poland;Spain;Bulgaria;Germany;Italy;United Kingdom;Sweden
1000EUCTR2009-015161-31-FR
(EUCTR)
19/10/201029/07/2010A Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's DiseaseA Phase 3, 12-Week, Double-Blind, Placebo-and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects with Moderate to Severe Parkinson's Disease Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
750Phase 3Portugal;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Poland;Bulgaria;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1001EUCTR2009-015928-28-SE
(EUCTR)
07/10/201013/08/2010A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09A double-blind, randomized, placebo controlled, dose finding study of oral eltoprazine for treatment of levodopa-induced dyskinesias (LID) in a levodopa challenge-dose setting in Parkinsons Disease. - ELTODYS09 Dyskinesias related to levodopa treatment in Parkinson´s diseaseProduct Name: Eltoprazine HCl
Product Code: Eltoprazine HCl
PsychoGenics IncNULLNot RecruitingFemale: yes
Male: yes
24Sweden
1002EUCTR2007-002964-90-CZ
(EUCTR)
06/10/201027/08/2010A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
605Phase 3Hungary;Finland;United Kingdom;Germany;Czech Republic;Netherlands;Belgium;Estonia;France;Spain;Austria
1003EUCTR2010-019418-25-DE
(EUCTR)
01/10/201019/07/2010Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 16.0;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ065
Product Name: AFQ056
Product Code: AFQ065
Novartis Pharma Sevices AGNULLNot RecruitingFemale: yes
Male: yes
244France;Canada;Finland;Australia;Germany;Italy;Japan
1004NCT01173731
(ClinicalTrials.gov)
October 201028/7/2010Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasParkinson Disease;Dyskinesia, Drug-Induced;LevodopaDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll66Phase 2United States;Australia;Canada;France;Germany;Italy;Finland;Spain
1005NCT01192529
(ClinicalTrials.gov)
October 201030/8/2010Evaluation of a Diet in Patients With Senile DementiaClinical Evaluation of an Specific Diet for People With Dementia DiseaseAlzheimer's Disease;Parkinson's Disease;Senile DementiaDietary Supplement: Supressi. T-Diet plus Range;Dietary Supplement: High Protein. T-Diet plus RangeVegenat, S.A.NULLRecruiting70 YearsN/ABoth184N/ASpain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1006EUCTR2010-019418-25-FR
(EUCTR)
29/09/201015/07/2010An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
244France;Finland;Germany;Italy
1007EUCTR2009-017238-39-DE
(EUCTR)
16/09/201028/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Germany;France;Italy
1008EUCTR2009-017238-39-FR
(EUCTR)
15/09/201009/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Germany;France;Italy
1009EUCTR2010-019418-25-FI
(EUCTR)
08/09/201021/07/2010An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ065
Product Name: AFQ056
Product Code: AFQ065
Product Name: AFQ056
Product Code: AFQ065
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
244France;Finland;Germany;Italy
1010EUCTR2009-013552-72-FI
(EUCTR)
07/09/201002/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1011NCT01536574
(ClinicalTrials.gov)
September 2, 201019/1/2012Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528Parkinson DiseaseDrug: Requip PRGlaxoSmithKlineNULLCompleted30 YearsN/AAll295Phase 3China
1012NCT01211587
(ClinicalTrials.gov)
September 201028/9/2010A Trial to Explore the Potential Benefit of Safinamide on Cognitive Impairment Associated With Parkinson's DiseaseA Double-blind, Randomized, Placebo-controlled, Parallel-group Phase II Study to Explore the Potential Beneficial Effects of Safinamide on Cognition in Non-demented Patients With Idiopathic Parkinson's Disease (PD) and Cognitive ImpairmentParkinson's Disease With Cognitive ImpairmentsDrug: safinamide;Drug: placeboNewronNULLCompleted45 Years80 YearsBoth103Phase 2United States;Spain
1013EUCTR2009-017238-39-BE
(EUCTR)
27/08/201014/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3France;Belgium;Germany;Italy
1014EUCTR2009-017253-35-GB
(EUCTR)
20/08/201006/08/2010Long-term study of patients who received ProSavin in the PS1/001/07 clinical trial.A multicentre, open-label extension study to determine the long term safety, tolerability and efficacy of ProSavin® in patients with bilateral, idiopathic Parkinson’s disease Patients with bilateral, idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: ProSavin
INN or Proposed INN: ProSavin
Oxford BioMedica (UK) LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
27United Kingdom
1015EUCTR2009-015161-31-FI
(EUCTR)
17/08/201023/06/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Study P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson’s Disease (Phase 3; Protocol No. P04938) Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
Product Code: N04BD02
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Schering-Plough Research Institute, a division of Schering CorporationNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Portugal;Finland;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Canada;Poland;Brazil;Peru;Bulgaria;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1016EUCTR2010-020769-25-FR
(EUCTR)
10/08/201009/07/2010Evaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médicalEvaluation médico-économique de l’infusion continue intra-duodénale d’une forme gélifiée de levodopa dans le traitement des formes avancées et sévères de maladie de parkinson par l’intermédiaire d’un dispositif médical Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Trade Name: DUODOPA
INN or Proposed INN: LEVODOPA/CARBIDOPA
INN or Proposed INN: LEVODOPA/BENZERASIDE
INN or Proposed INN: PERGOLIDE
INN or Proposed INN: LISURIDE
INN or Proposed INN: BROMOCRIPTINE
INN or Proposed INN: ROPINIROLE
INN or Proposed INN: PRAMIPEXOLE
INN or Proposed INN: IPRONIAZID
Other descriptive name: MOCLOBEMIDE
INN or Proposed INN: AMANTADINE
INN or Proposed INN: CLOZAPINE
INN or Proposed INN: SELEGILINE
INN or Proposed INN: RASAGILINE
INN or Proposed INN: ENTACAPONE
INN or Proposed INN: TOLCAPONE
CHU de PoitiersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
1017NCT01191944
(ClinicalTrials.gov)
August 201030/8/2010Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) PatientsA Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With LevodopaParkinson DiseaseDrug: pramipexole immediate release tablet;Drug: pramipexole extended release tabletBoehringer IngelheimNULLCompleted30 YearsN/AAll475Phase 3China
1018NCT01228851
(ClinicalTrials.gov)
August 201031/8/2010Balance Training in Parkinson's Disease Using the Wii Balance BoardA Pilot Study of the Effects of Balance Training Using the Wii Balance Board on Balance and Ambulation in Adults With Parkinson's DiseaseParkinson's DiseaseOther: Balance TrainingRehabilitation Institute of ChicagoNULLCompleted18 YearsN/ABoth10N/AUnited States
1019EUCTR2009-017182-38-ES
(EUCTR)
26/07/201025/05/2010Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. Enfermedad de Parkinson idiopática (parálisis agitante)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals DivisionNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
1020NCT01155466
(ClinicalTrials.gov)
July 14, 201030/6/2010A Placebo- and Active Controlled Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (P04938)A Phase 3, 12-Week, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Efficacy and Safety Study of Preladenant in Subjects With Moderate to Severe Parkinson's Disease (Phase 3;Protocol No. P04938)Parkinson DiseaseDrug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Placebo to Preladenant Tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo to Rasagiline capsuleMerck Sharp & Dohme Corp.NULLCompleted30 Years85 YearsAll778Phase 3Austria;Brazil;Bulgaria;Canada;Czech Republic;Finland;France;Germany;India;Israel;Italy;Japan;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1021EUCTR2010-018650-12-FR
(EUCTR)
13/07/201006/05/2010Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOXEvaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX maladie de Parkinson
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: CYMBALTA
Product Name: duloxetine
Trade Name: APOKINON
Product Name: apomorphine
Trade Name: MODOPAR
Product Name: levodopa
Trade Name: MOTILIUM
Product Name: dompéridone
CHU de ToulouseNULLNot RecruitingFemale: yes
Male: yes
Phase 3France
1022EUCTR2009-017182-38-LT
(EUCTR)
10/07/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
1023EUCTR2009-017182-38-DE
(EUCTR)
09/07/201007/05/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. Idiopathic Parkinson’s disease (paralysis agitans).
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals DivisionNULLNot RecruitingFemale: yes
Male: yes
500Estonia;Spain;Poland;Lithuania;Latvia;Germany
1024EUCTR2009-017182-38-PL
(EUCTR)
07/07/201020/05/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. Idiopathic Parkinson’s disease (paralysis agitans).
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
1025NCT01155479
(ClinicalTrials.gov)
July 6, 201030/6/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson's DiseaseParkinson DiseaseDrug: Preladenant 2 mg tablet;Drug: Preladenant 5 mg tablet;Drug: Preladenant 10 mg tablet;Drug: Rasagiline 1 mg capsule;Drug: Placebo for Rasagiline 1 mg capsule;Drug: Placebo for PreladenantMerck Sharp & Dohme Corp.NULLTerminated30 Years85 YearsAll1022Phase 3Argentina;Bulgaria;Canada;Chile;Colombia;Czech Republic;Finland;France;Germany;Hungary;India;Israel;Italy;Mexico;Peru;Poland;Russian Federation;Spain;Sweden;Turkey;United Kingdom;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1026NCT01171313
(ClinicalTrials.gov)
July 201026/7/2010A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease SubjectsA Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: XP21279 and carbidopa (experimental);Drug: Sinemet (comparator);Drug: Placebo for XP21279 and carbidopa;Drug: Placebo for SinemetXenoPort, Inc.NULLCompleted30 Years80 YearsBoth35Phase 2United States
1027NCT01174004
(ClinicalTrials.gov)
July 201030/7/2010A Study of the Safety and Efficacy of Pimavanserin in Patients With Parkinson's Disease PsychosisA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of Pimavanserin in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: pimavanserin tartrate;Drug: placeboACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll199Phase 3United States;Canada
1028NCT01174810
(ClinicalTrials.gov)
July 20102/8/2010Exendin-4 as a Treatment for Parkinson's Disease - Pilot StudyAn Open Label, Single Site, 12 Month, Phase II, Randomised Controlled Trial Evaluating the Safety and Efficacy of Exendin-4 (Exenatide) in the Treatment of Patients With Moderate Severity Parkinson's Disease.Parkinson's DiseaseDrug: ExenatideUniversity College, LondonNULLActive, not recruiting45 Years70 YearsBoth40Phase 2United Kingdom
1029NCT01149811
(ClinicalTrials.gov)
July 201010/6/2010A Study Comparing the Safety and Tolerability of Two Doses of Fipamezole in Adult Patients With Parkinson's DiseaseA Randomized, Double-Blind, Crossover Study Comparing the Safety and Tolerability of Two Dose Regimens of Oromucosal Fipamezole ODT in Adult Patients With Parkinson's Disease Who Are Receiving LevodopaParkinson's DiseaseDrug: Fipamezole ODT;Drug: Fipamezole ODT Cohort 2Valeant Pharmaceuticals International, Inc.NULLCompleted30 Years75 YearsBoth27United States
1030NCT01435915
(ClinicalTrials.gov)
June 28, 20101/9/2011Ropinirole PR Pharmacokinetics Study Among Chinese Healthy SubjectsA Single Dose and Repeat Dose Study to Investigate the Pharmacokinetics of Ropinirole After Single and Multiple Doses of a PR-formulation in Chinese Healthy Male and Female SubjectsParkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted18 Years45 YearsAll24Phase 1China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1031EUCTR2009-017238-39-IT
(EUCTR)
21/06/201013/07/2010A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - NDA Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10061536
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA LEVODOPA
Trade Name: NACOM 100
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: COMTAN
INN or Proposed INN: Entacapone
IMPAX LABORATORIES, INC.NULLNot RecruitingFemale: yes
Male: yes
56Germany;France;Italy
1032EUCTR2009-017182-38-LV
(EUCTR)
11/06/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
1033EUCTR2009-013886-24-SE
(EUCTR)
08/06/201021/12/2009Efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s diseaseA randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 Excessive daytime sleepiness in Parkinson’s Disease
MedDRA version: 14.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLNot RecruitingFemale: yes
Male: yes
246Czech Republic;Germany;Sweden
1034NCT01227681
(ClinicalTrials.gov)
June 201022/10/2010Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's DiseaseA Double-Blind, Placebo-Control, Study of the Neuro-protective Effect of Granulocyte-colony Stimulating Factor on Early Stage Parkinson's DiseaseParkinson DiseaseDrug: G-CSF;Drug: PlaceboBuddhist Tzu Chi General HospitalNULLTerminated40 Years65 YearsAll4Phase 2Taiwan
1035NCT01140841
(ClinicalTrials.gov)
June 20108/6/2010A Study of Safety and Tolerability of Fipamezole in Adult Subjects With Parkinson's Disease Who Are Receiving LevodopaA Randomized, Double-Blind, Placebo-Controlled, Ascending Dose-Escalation Study of Safety and Tolerability of Oromucosal Fipamezole ODT in Adult Subjects With Parkinson's Disease Who Are Receiving LevodopaParkinson's DiseaseDrug: Fipamezole ODT;Drug: PlaceboValeant Pharmaceuticals International, Inc.NULLCompleted30 Years75 YearsBoth40United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1036NCT01176240
(ClinicalTrials.gov)
June 201030/7/2010A Two Part Study (306A/306B) to Assess Droxidopa in Treatment of NOH in Patients With Parkinson's DiseaseA Multi-center, Double-blind, Randomized, Parallel-Group, Placebo-Controlled Study to Assess the Clinical Effect of Droxidopa in the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Patients With Parkinson's DiseaseOrthostatic Hypotension;Parkinson's DiseaseDrug: Droxidopa;Other: PlaceboChelsea TherapeuticsNULLCompleted18 YearsN/AAll225Phase 3United States
1037EUCTR2010-018904-94-IT
(EUCTR)
31/05/201014/03/2012EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASEEFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: NERIXIA*IM EV 1F 25MG
INN or Proposed INN: Bisphosphonates
Other descriptive name: Neridronic acid
FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
1038EUCTR2010-019354-40-AT
(EUCTR)
26/05/201026/04/2010Überprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem ParkinsonsyndromÜberprüfung des Einflusses der STN-Stimulation auf die Schmerzschwelle von Patienten mit Idiopathischem Parkinsonsyndrom Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Madopar
INN or Proposed INN: LEVODOPA
INN or Proposed INN: BENSERAZIDE
Universitätsklinik für Neurologie InnsbruckNULLNot RecruitingFemale: yes
Male: yes
15Austria
1039EUCTR2009-016143-19-AT
(EUCTR)
26/05/201012/05/2010Validierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte StudieValidierung von Dyskinesie-Rating-Skalen anhand des therapeutischen Effektes von Amantadin - eine placebokontrollierte Studie Parkinson's diseaseTrade Name: Amantadin-ratiopharm 100mg
Other descriptive name: AMANTADINE HYDROCHLORIDE
CHU de ToulouseNULLNot RecruitingFemale: yes
Male: yes
66France;Austria
1040EUCTR2010-019396-29-IT
(EUCTR)
18/05/201005/03/2012Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease.Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD Patients with idiopathic Parkinson's Disease.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: COMTAN
INN or Proposed INN: Entacapone
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: STALEVO*100CPR 50/12,5/200MG
INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor
Trade Name: STALEVO*100CPR 100/25/200MG
INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1041EUCTR2009-017182-38-EE
(EUCTR)
14/05/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
1042JPRN-UMIN000003601
2010/05/0118/05/2010Comparative study of ropinirole and entacapone for the treatment of wearing-off in advanced Parkinson's disease patients Parkinson's diseaseIncrease dosage of ropinirole
Addition of entacapone
Kansai Medical UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female30Not selectedJapan
1043NCT01130493
(ClinicalTrials.gov)
May 201024/5/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: CLEImpax Laboratories, LLCNULLCompleted30 YearsN/AAll110Phase 3United States;France;Germany;Italy
1044NCT01532115
(ClinicalTrials.gov)
May 201023/1/2012Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and WomenA Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and WomenParkinson DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: moxifloxacinBial - Portela C S.A.NULLCompleted18 Years55 YearsBoth64Phase 1France
1045NCT01283347
(ClinicalTrials.gov)
May 201011/1/201118F-DTBZ for l Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET ImagingPhase II Study of 18F-DTBZ: The Differential Diagnosis of Parkinson's Disease and Monitoring the Severity of Disease by VMAT2 PET ImagingParkinson's DiseaseDrug: 18F-DTBZChang Gung Memorial HospitalNULLCompleted50 Years80 YearsBoth100Phase 2Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1046EUCTR2009-018137-37-GB
(EUCTR)
14/04/201018/03/2010An open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trialAn open label, single site, 12 month, Phase II, randomised controlled trial evaluating the safety and efficacy of Exendin-4 (Exenatide) in the treatment of patients with moderate severity Parkinson's disease. - Exendin-4 as a treatment for Parkinson's disease- pilot trial Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
University College LondonNULLNot Recruiting Female: yes
Male: yes
40Phase 2United Kingdom
1047JPRN-JapicCTI-101198
01/4/2010A double-blind confirmatory study for AD-810N (zonisamide) in patients with Parkinson's disease (Phase III)A double-blind confirmatory study for AD-810N (zonisamide) in patients with Parkinson's disease (Phase III) Parkinson's diseaseIntervention name : Zonisamide
Dosage And administration of the intervention : Oral
Control intervention name : null
Dainippon Sumitomo Pharma Co., Ltd.NULL2074BOTH360Phase 3NULL
1048NCT01103011
(ClinicalTrials.gov)
April 201012/4/2010Safety, Tolerability and Pharmacokinetic Profile of Levodopa Administered With Continuous Administration of ND0611A Phase I, Single Center, Blinded, Controlled Study Evaluating Safety, Tolerability and Pharmacokinetic Profile of Levodopa Following Repeated Administration of Oral Levodopa/Carbidopa and Continuously Delivered ND0611Parkinson's DiseaseDrug: ND0611NeuroDerm Ltd.NULLCompleted18 Years50 YearsMale8Phase 1Israel
1049NCT01113320
(ClinicalTrials.gov)
April 20108/4/2010Safinamide in Levodopa Induced Dyskinesia in Parkinson's Disease SubjectsA Double-blind, Randomized, Placebo-controlled, Parallel-group, Dose Escalation Trial to Explore the Potential Antidyskinetic Properties of Safinamide in Patients With Parkinson's Disease Suffering From Levodopa Induced DyskinesiasParkinson's DiseaseDrug: Placebo;Drug: SafinamideNewronNULLCompleted30 YearsN/ABoth26Phase 2Austria;Canada;France;Germany;South Africa
1050EUCTR2009-017174-20-DE
(EUCTR)
15/03/201007/01/2010A trial to determine if safinamide can attenuate levodopa induced dyskinesia in Parkinson’s disease.A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. - LID study Idiopathic Parkinson's disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015E, EMD 1195686, MSC2191632B
INN or Proposed INN: safinamide
Other descriptive name: (S)-(+)-2-(4-(3-fluorobenzyl)oxybenzyl)aminopropanamide methanesulfonate
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
24France;Canada;Austria;South Africa;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1051EUCTR2009-013886-24-DE
(EUCTR)
03/03/201029/10/2009A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease - HARPS-2 Excessive daytime sleepiness in Parkinson’s Disease
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLNot RecruitingFemale: yes
Male: yes
246Czech Republic;Germany;Sweden
1052NCT01066442
(ClinicalTrials.gov)
March 20109/2/2010Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's DiseaseA Randomised, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38 Week Open Label Extension PhaseParkinson's DiseaseDrug: BF2.649 (Pitolisant)BioprojetNULLCompleted30 Years80 YearsBoth273Phase 3Germany
1053NCT01092065
(ClinicalTrials.gov)
March 201022/3/2010Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With Moderate-severe L-dopa Induced DyskinesiaA 6-week, Double-blind, Placebo-controlled, Randomized, Multicenter Study to Explore the Efficacy and Safety of AFQ056 When Combined With Increased Doses of L-dopa in Parkinson's Disease Patients With OFF Time and Moderate-severe L-dopa Induced DyskinesiaParkinson's DiseaseDrug: AFQ056 with L-dopa;Drug: PlaceboNovartisNULLCompleted30 Years80 YearsAll23Phase 2United States
1054NCT01097421
(ClinicalTrials.gov)
March 201025/3/2010Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s DiseaseInfluence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll329N/ASweden
1055NCT01096186
(ClinicalTrials.gov)
March 201025/3/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseAn Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX066 95 mg;Drug: IPX066 145 mg;Drug: IPX066 195 mg;Drug: IPX066 245 mgImpax Laboratories, LLCNULLCompleted30 YearsN/AAll617Phase 3United States;Canada;Estonia;Germany;Latvia;Lithuania;Poland;Romania;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1056NCT01503944
(ClinicalTrials.gov)
March 201014/7/2010A Trial of 18F-AV-133 and 18F-AV-45 Positron Emission Tomography (PET)Detection of Striatal Dopaminergic Degeneration and Neocortical Amyloid Pathology in Patients With Dementia With Lewy Bodies, Alzheimer's Disease, Parkinson's Disease, and Healthy Elderly VolunteersDementia With Lewy Bodies;Alzheimer's Disease;Parkinson's DiseaseDrug: 18F-AV-133;Drug: 18F-AV-45Avid RadiopharmaceuticalsNULLCompleted50 YearsN/ABoth30Phase 1;Phase 2United States
1057NCT02101190
(ClinicalTrials.gov)
March 201020/1/2012Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic ImpairmentOpen-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic ImpairmentParkinson's DiseaseDrug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 Years65 YearsAll16Phase 1France;Russian Federation
1058EUCTR2009-017174-20-FR
(EUCTR)
24/02/201018/01/2010A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias.A double-blind, randomized, placebo-controlled, parallel-group, dose escalation trial to explore the potential antidyskinetic properties of safinamide in patients with Parkinson's disease suffering from levodopa induced dyskinesias. Idiopathic Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Germany;France;Austria
1059EUCTR2007-002963-28-DE
(EUCTR)
17/02/201022/12/2009A trial to determine the efficacy and safety of a low (50mg/day) and high dose (100mg / day) of safinamide, as add-on therapy, in patients with early Parkinson´s Disease treated with a sigle dopamin antagonistA phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
1060NCT01154166
(ClinicalTrials.gov)
February 15, 201029/6/2010A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-DopaA Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-DopaParkinson DiseaseDrug: ReQuip PR;Drug: PlaceboGlaxoSmithKlineNULLCompleted30 YearsN/AAll347Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1061EUCTR2009-014688-37-PL
(EUCTR)
09/02/201020/01/2010A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/AA Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
1062EUCTR2009-016360-37-SE
(EUCTR)
06/02/201004/12/2009TREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDYTREATMENT OF DYSKINESIAS IN PARKINSON’S DISEASE WITH OSU6162 – A PILOT STUDY Parkinsons disease is complicated by dyskinesias and dystonia. Due stabilizing properties, we believe (-)-OSU6162 may alleviate dyskinesias, without causing parkinsonism. Aim: To evaluate in a double-blind cross over pilot study whether OSU6162 attenuates dyskinesias without worsening parkinsonism in PD patients with motor complications using clinical examination and patient diaries.Björn HolmbergNULLNot Recruiting Female: yes
Male: yes
20Phase 1;Phase 2Sweden
1063NCT02169414
(ClinicalTrials.gov)
February 201024/1/2012Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa PharmacokineticsEffect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy SubjectsParkinson's Disease (PD)Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa/carbidopa 100/25;Drug: Placebo;Drug: levodopa/benserazide 100/25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll74Phase 1France
1064NCT01568047
(ClinicalTrials.gov)
February 201029/3/2012Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) PatientsMulticentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon)Parkinson's DiseaseDrug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/BenzerazideBial - Portela C S.A.NULLCompleted30 YearsN/AAll40Phase 2Romania;Ukraine
1065EUCTR2008-005492-94-BE
(EUCTR)
25/01/201012/08/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1066EUCTR2008-001329-33-CZ
(EUCTR)
18/01/201003/12/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
INN or Proposed INN: levodopa
Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: carbidopa monohydrate
Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid
AbbVie IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
275Portugal;Czech Republic;Thailand;Poland;Australia;Russian Federation;Israel;United Kingdom;Italy;New Zealand
1067EUCTR2008-005492-94-NL
(EUCTR)
18/01/201025/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - Idiopathic Parkinson's Disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1285Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
1068EUCTR2009-017416-33-DE
(EUCTR)
18/01/201021/12/2009Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. Male and female patients with Parkinson´s disease meeting UKPDS criteria
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
1069EUCTR2009-012643-42-NL
(EUCTR)
06/01/201030/11/2009Freezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's diseaseFreezing of gait in Parkinson's disease: in search of the underlying mechanism and the application of a new treatment option - Freezing of gait in Parkinson's disease Parkinson's disease, in particular the symptom Freezing of GaitTrade Name: Ritalin
Product Name: Not applicable
Product Code: Not applicable
INN or Proposed INN: METHYLPHENIDATE HYDROCHLORIDE
Other descriptive name: Ritalin
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
1070JPRN-UMIN000007497
2010/01/0114/03/2012Trial of molecular hydrogen water in Parkinson disease Parkinson diseaseThe subjects should make 1000 ml of molecular hydrogen water which contains 1.6 ppm dissolved hydrogen by Aquerable, and consume for 48 weeks.
Placebo water which is not contained molecular hydrogen water made from pseudo-machine. The subjects consume for48 weeks.
Department of Neurology, Juntendo University School of MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female18Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1071JPRN-UMIN000003080
2010/01/0130/01/2010Double Blind Study for Effects of Donepezil Hydrochloride on Parkinson's Disease Parkinson's diseaseDonepezil hydrochloride (3mg for 2 weeks, 5mg for 2 weeks)
Placebo
Clinical Research Center, Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up complete40years-old75years-oldMale and Female30Not applicableJapan
1072NCT01063621
(ClinicalTrials.gov)
January 20104/2/2010Extended Long-Term Safety Study of KW-6500Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)Parkinson's DiseaseDrug: KW-6500Kyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll27Phase 3Japan
1073NCT01018264
(ClinicalTrials.gov)
January 201019/11/2009Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's DiseaseURGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's DiseaseOveractive Bladder in Parkinson's DiseaseDrug: solifenacin succinate (VESIcare);Drug: placeboUniversity of South FloridaNULLCompleted40 Years80 YearsAll23Phase 4United States
1074NCT01058291
(ClinicalTrials.gov)
January 201027/1/2010Placebo-Controlled Double-Blind Crossover Comparative Study of KW-6500Phase 3 Study of KW-6500 (Placebo-Controlled Double-Blind Crossover Comparative Study in Patients With Parkinson's Disease)Parkinson's DiseaseDrug: KW-6500;Drug: KW-6500 PlaceboKyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll31Phase 3Japan
1075EUCTR2009-014688-37-ES
(EUCTR)
30/12/200921/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Sinemet-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1076EUCTR2009-011541-24-NL
(EUCTR)
30/12/200929/05/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
1077EUCTR2009-014688-37-DE
(EUCTR)
15/12/200907/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
1078EUCTR2008-005492-94-GB
(EUCTR)
09/12/200901/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
1079EUCTR2009-012897-12-RO
(EUCTR)
08/12/200930/03/2015A double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitorA double-blind, randomised, placebo-controlled study to investigate the tolerability and the effect of three multiple-dose regimens of BIA 9-1067 on the levodopa pharmacokinetics, catechol-0-methyltransferase activity and motor response in parkinson´s disease patients treated with levodopa/dopa-decarboxylaseinhibitor Parkinson’s Disease
MedDRA version: 17.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852
Product Name: BIA 9-1067
Product Code: BIA 9-1067
Product Name: BIA 9-1067
Product Code: BIA 9-1067
Trade Name: SINEMET 25/100
INN or Proposed INN: LEVODOPA
Other descriptive name: ANHYDROUS CARBIDOPA
Trade Name: Restex Tabletten
INN or Proposed INN: LEVODOPA
INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE
BIAL-Portela & Ca, SANULLNot RecruitingFemale: yes
Male: yes
32Romania
1080EUCTR2009-014688-37-FR
(EUCTR)
04/12/200909/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Germany;France;Spain;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1081EUCTR2009-012419-16-DE
(EUCTR)
03/12/200920/10/2009Influence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PDInfluence of the Non-Ergot Dopamine agonist Piribedil on vigilance and cognitive function in patients with Parkinson's disease compared to other oral Non-Ergot Dopamine agonists - PIVICOG-PD idiopathic Parkinson's disease
MedDRA version: 12.0;Level: PT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Clarium 50 mg Retardtabletten
INN or Proposed INN: piribedil
Desitin Arzneimittel GmbHNULLNot RecruitingFemale: yes
Male: yes
Germany
1082NCT01070628
(ClinicalTrials.gov)
December 200923/11/2009Levodopa Concentration Profile With Stalevo 75/125 mgLevodopa Concentration Profile After Repeated Doses of Different Stalevo® Strengths With 3.5 Hours Dosing Frequency; an Open, Randomised, Crossover, Levodopa/Carbidopa Controlled Single Centre Study in Healthy Subjects, Two Parallel GroupsParkinson's DiseaseDrug: Stalevo (levodopa/ carbidopa/ entacapone);Drug: Sinemet (levodopa/carbidopa)Orion Corporation, Orion PharmaNULLCompleted18 Years70 YearsBoth20Phase 1Finland
1083NCT01168596
(ClinicalTrials.gov)
December 200919/2/2010Rasagiline for the Symptomatic Treatment of Fatigue in Parkinson's DiseaseRasagiline for the Symptomatic Treatment of Fatigue in Parkinson's Disease: A Bi-Center, Placebo-Controlled Study (The REST Fatigue Trial)Parkinson's DiseaseDrug: Rasagiline;Drug: PlaceboUniversity of FloridaNULLCompleted40 Years85 YearsAll30Phase 4United States
1084NCT01036139
(ClinicalTrials.gov)
December 200911/12/2009Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's DiseaseA Randomized, Multicenter 12-Week Double-blind Placebo-controlled Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson's Disease Followed by a 38-Week Open-label Extension PhaseParkinson's DiseaseDrug: BF2.649 (pitolisant)BioprojetNULLCompleted30 Years80 YearsBoth268Phase 3France
1085NCT01032486
(ClinicalTrials.gov)
December 200911/12/2009Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's DiseaseAn Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease SubjectsParkinson's DiseaseDrug: Rasagiline mesylateTeva Pharmaceutical IndustriesNULLCompletedN/AN/ABoth120Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1086EUCTR2009-013886-24-CZ
(EUCTR)
26/11/200918/11/2009A Randomized, Multicenter, 12-Week, Double-blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson Disease, followed by a 9-months Open-Label Extension Phase - HARPS-2 Excessive daytime sleepiness in Parkinson’s Disease
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLNot RecruitingFemale: yes
Male: yes
246Phase -Germany;Czech Republic;Sweden
1087EUCTR2008-005492-94-FR
(EUCTR)
25/11/200901/10/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1285Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
1088EUCTR2008-005492-94-ES
(EUCTR)
23/11/200918/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson - Idiopathic Parkinson's DiseaseEnfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1285Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
1089EUCTR2009-013885-14-FR
(EUCTR)
23/11/200925/09/2009A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phaseA randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson’s disease followed by a 38-Week open-label extension phase Excessive daytime sleepiness in Parkinson’s Disease
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
246Phase AFrance;Spain
1090EUCTR2009-013885-14-ES
(EUCTR)
12/11/200923/09/2009A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson.
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
246France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1091EUCTR2009-013004-31-IT
(EUCTR)
02/11/200902/11/2009Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons diseaseEarly combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease Patients with Parkinson`s diesease
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
INN or Proposed INN: Rasagiline
INN or Proposed INN: Ropinirole
UNIVERSITA` DEGLI STUDI DI PARMANULLNot RecruitingFemale: yes
Male: yes
Italy
1092NCT01023282
(ClinicalTrials.gov)
November 20091/12/2009Safety and Tolerability Study Evaluating ACR325 in Parkinson's Disease PatientsRandomised, Double-blind, Placebo-controlled Study Evaluating Safety and Tolerability of ACR325 in Parkinson's Disease Patients, With Evaluation of the Effect on Levodopa Induced Dyskinesias as a Secondary MeasureParkinson's Disease;TolerabilityDrug: ACR325;Drug: PlaceboNeuroSearch A/SNULLCompleted30 Years75 YearsBoth22Phase 1Germany
1093NCT01532128
(ClinicalTrials.gov)
November 200923/1/2012Effect of BIA 9-1067 on Rasagiline PharmacokineticsEffect of BIA 9-1067 on Rasagiline Pharmacokinetics in Healthy SubjectsParkinson DiseaseDrug: rasagiline;Drug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll24Phase 1France
1094NCT01028209
(ClinicalTrials.gov)
November 20098/12/2009Evaluation of [18F] PBR06 and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F] PBR06Institute for Neurodegenerative DisordersNULLTerminated18 YearsN/AAll12Phase 1United States
1095NCT01532141
(ClinicalTrials.gov)
November 200923/1/2012Effect of Rasagiline on BIA 9-1067 PharmacokineticsEffect of Rasagiline on BIA 9-1067 Pharmacokinetics in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: RasagilineBial - Portela C S.A.NULLCompleted18 Years45 YearsAll25Phase 1France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1096NCT01519284
(ClinicalTrials.gov)
November 200923/1/2012Study of BIA 9-1067 to Investigate Its Effect on Levodopa PharmacokineticA Double-blind, Randomised, Placebo- and Active-controlled Multiple-dose Study of BIA 9-1067 to Investigate Its Effect on Levodopa Pharmacokinetics Following a Levodopa/Carbidopa 100/25 mg Single-dose in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067 5 mg;Drug: Entacapone;Drug: Placebo;Drug: levodopa/carbidopa;Drug: BIA 9-1067 15 mg;Drug: BIA 9-1067 30 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll82Phase 1Portugal
1097NCT00985517
(ClinicalTrials.gov)
October 29, 200925/9/2009Safety and Efficacy of CERE-120 in Subjects With Parkinson's DiseaseA Phase 1/2 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseBiological: CERE-120: Adeno-Associated Virus Delivery of Neurturin;Procedure: Sham SurgerySangamo TherapeuticsNULLCompleted35 Years70 YearsAll57Phase 1;Phase 2United States
1098EUCTR2008-005492-94-HU
(EUCTR)
27/10/200922/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
1099EUCTR2008-004146-88-PL
(EUCTR)
19/10/200931/08/2009A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
1100EUCTR2008-005492-94-SK
(EUCTR)
14/10/200922/10/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1101EUCTR2009-011541-24-GB
(EUCTR)
09/10/200929/05/2009A trial to follow-up subjects with Parkinson's disease who participated to the ADAGIO study in order to study the long-term effects of the drug rasagilineAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700Phase 4Portugal;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Romania;Germany;Netherlands
1102EUCTR2008-005492-94-AT
(EUCTR)
02/10/200903/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
1103EUCTR2008-001329-33-PT
(EUCTR)
02/10/200919/08/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
INN or Proposed INN: levodopa
Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: carbidopa monohydrate
Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid
AbbVie IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
275Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand
1104EUCTR2008-005492-94-EE
(EUCTR)
01/10/200915/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
1105NCT00914095
(ClinicalTrials.gov)
October 20092/6/2009Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease (PARKGAIT-II)Study of Methylphenidate to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicentric TrialParkinson's Disease;Gait Disorders, Neurologic;DementiaDrug: methylphenidate;Drug: placeboUniversity Hospital, LilleNULLCompleted30 Years80 YearsBoth69Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1106NCT01028586
(ClinicalTrials.gov)
October 20097/12/2009MOTION, Safinamide in Early Idiopathic Parkinson's Disease (IPD), as add-on to Dopamine Agonist (Extension of Trial 27918)A Phase III, Double-blind, Placebo-controlled Extension Trial to Investigate the Long-term Efficacy and Safety of Low (50 mg/Day) and High (100 mg/Day) Dose Safinamide, as add-on Therapy in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine AgonistIdiopathic Parkinson's DiseaseDrug: Safinamide, MAO-B inhibitor;Drug: PlaceboNewronNULLTerminated30 Years80 YearsBoth507Phase 3Switzerland
1107NCT00957918
(ClinicalTrials.gov)
October 200911/8/2009Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa TherapyRandomized, Double-Blind, Parallel Group, Placebo Controlled Safety, Tolerability and Efficacy Study of NP002 in Subjects With Idiopathic Parkinson's Disease With Dyskinesias Due to Levodopa TherapyParkinson's DiseaseDrug: nicotine;Other: placebo comparatorNeuraltus Pharmaceuticals, Inc.NULLCompleted30 Years83 YearsBoth65Phase 1;Phase 2United States
1108NCT00943748
(ClinicalTrials.gov)
October 200920/7/2009Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's DiseaseEfficacy and Safety of the Iron Chelator Deferiprone on Iron Overload in the Brain in Parkinson's DiseaseParkinson's DiseaseDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted30 Years80 YearsBoth40Phase 2;Phase 3France
1109NCT00957203
(ClinicalTrials.gov)
October 20097/8/2009Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease PatientsLong-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)Parkinson's DiseaseDrug: IstradefyllineKyowa Hakko Kirin Company, LimitedNULLCompleted20 YearsN/ABoth308Phase 3Japan
1110NCT01108029
(ClinicalTrials.gov)
October 200920/7/2009Study of Memantine for Gait Disorders And Attention Deficit In Parkinson's DiseaseStudy of Memantine to Treat Gait Disorders And Attention Deficit In Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Monocentric TrialParkinson's Disease;Gait Disorders, NeurologicDrug: memantine;Drug: placeboUniversity Hospital, LilleNULLCompleted30 Years80 YearsBoth28Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1111NCT01631825
(ClinicalTrials.gov)
October 200925/6/2012A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll321Phase 3Japan
1112NCT01016470
(ClinicalTrials.gov)
October 200928/9/2009Efficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s DiseaseEfficacy of Nutritional Supplement VIUSID/ALZER in Patients With Parkinson`s DiseaseParkinson`s DiseaseDietary Supplement: VIUSID/ALZER;Dietary Supplement: PlaceboCatalysis SLNULLCompleted20 Years90 YearsBoth100Phase 3Cuba
1113ChiCTR-TRC-12002150
2009-09-292012-05-06Study on Optimization of The Comprehensive Therapeutic Plan for Parkinson's Disease in Different StagesStudy on Optimization of The Comprehensive Therapeutic Plan by Stages for Parkinson's Disease Parkinson's DiseaseThe early treatment group:Xifeng Dingchan Pill;The early control group:Madopar tablets;Interim treatment group:Xifeng Dingchan Pill, Madopar tablets and Piribedil tablets;Henan University of Traditional Chinese MedicineNULLRecruiting5075BothThe early treatment group:80;The early control group:80;Interim treatment group:160;China
1114EUCTR2006-005186-18-NL
(EUCTR)
25/09/200929/05/2008Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
1115EUCTR2009-011541-24-DE
(EUCTR)
22/09/200927/07/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1116NCT01371682
(ClinicalTrials.gov)
September 18, 200910/6/2010A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and ArandaAn Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and ArandaParkinson DiseaseDrug: Ropinirole XLGlaxoSmithKlineNULLCompleted18 Years50 YearsAll50Phase 1Belgium
1117EUCTR2009-011541-24-PT
(EUCTR)
09/09/200929/07/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
700France;Portugal;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
1118NCT00986245
(ClinicalTrials.gov)
September 200924/9/2009Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-dailyAn Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson DiseaseParkinson DiseaseDrug: Ropinirole Prolonged releaseSeoul National University HospitalNULLCompleted30 Years80 YearsAll82Phase 4Korea, Republic of
1119NCT00903838
(ClinicalTrials.gov)
September 200914/5/2009A Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations and Dyskinesia.Advanced Stage Parkinson's DiseaseDrug: pardoprunox;Drug: pramipexoleAbbott ProductsNULLTerminated30 YearsN/ABoth37Phase 2Germany;Italy;Portugal
1120NCT00974974
(ClinicalTrials.gov)
September 200910/9/2009A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll471Phase 3United States;Canada;France;Germany;Poland;Romania;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1121NCT00794313
(ClinicalTrials.gov)
September 200919/11/2008Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's DiseaseQuantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's DiseaseParkinson's DiseaseDrug: Amantadine 300 mg;Drug: Topiramate;Drug: Sugar PillOregon Health and Science UniversityNULLTerminated21 YearsN/AAll3N/AUnited States
1122NCT00986414
(ClinicalTrials.gov)
September 200929/9/2009Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseParkinson Disease;DyskinesiasDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years80 YearsAll260Phase 2Australia;Canada;Finland;France;Germany;Italy;Japan;Spain
1123NCT01026428
(ClinicalTrials.gov)
September 20091/12/2009A Study to Assess the Effect of Safinamide on Levodopa PharmacokineticsA Randomised, Double-blind, Placebo-controlled, Two-period, Two-sequence-crossover Interaction Study to Assess the Effect of Safinamide on Levodopa Pharmacokinetics in Subjects With Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: Safinamide + Levodopa;Other: Placebo + LevodopaNewronNULLCompleted30 YearsN/ABoth24Phase 1;Phase 2Italy
1124EUCTR2009-011541-24-ES
(EUCTR)
27/08/200926/06/2009 An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up Parkinson's Disease Enfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700Phase 4Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
1125EUCTR2008-004146-88-BG
(EUCTR)
13/08/200913/07/2009An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonistA phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015
Newron PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
498Phase 3United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1126EUCTR2008-008712-98-DE
(EUCTR)
07/08/200913/07/200913-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ056
Other descriptive name: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Other descriptive name: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Other descriptive name: AFQ056
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
198France;Finland;Spain;Germany;Italy
1127NCT00970333
(ClinicalTrials.gov)
August 200931/8/2009Evaluation of [18F] FEPPA and PET Imaging as a Marker of Inflammation in Subjects With Neurological ConditionsEvaluation of [18F] FEPPA and PET as a Marker of Inflammation in Subjects With Neurological ConditionsAlzheimer Disease;Parkinson Disease;Multiple SclerosisDrug: [18F]-FEPPAInstitute for Neurodegenerative DisordersNULLCompleted18 YearsN/ABoth3Phase 1United States
1128NCT01580787
(ClinicalTrials.gov)
August 200916/4/2012Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual EnvironmentFunctional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual EnvironmentParkinson´s DiseaseDevice: Balance Training with Nintendo Wii Fit;Other: Physical TherapySao Camilo University CenterNULLCompleted65 Years85 YearsBoth32N/ANULL
1129NCT03316365
(ClinicalTrials.gov)
August 200916/10/2017Long-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's DiseaseLong-term Training Effects of Rhythmic Auditory Stimulation on Gait in Patients With Parkinson's DiseaseContinuous Rhythmic Auditory Stimulation;Intermittent Rhythmic Auditory StimulationOther: Rhythmic Auditory Stimulation (RAS)University of TorontoPoudre Valley Health System Fort Collins CO;Colorado State UniversityCompleted18 YearsN/AAll60N/ANULL
1130EUCTR2008-004146-88-PT
(EUCTR)
31/07/200914/04/2009A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1131EUCTR2009-011736-35-FR
(EUCTR)
27/07/200906/08/2009Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYSEtude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS Maladie de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: LODALÈS®
Product Code: simvastatine
CHU de BordeauxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2France
1132EUCTR2009-011541-24-FR
(EUCTR)
17/07/200919/06/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700Phase 4Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
1133EUCTR2009-011541-24-HU
(EUCTR)
10/07/200905/06/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700Phase 4Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
1134NCT00955604
(ClinicalTrials.gov)
July 20096/8/2009Azilect + Antidepressant Chart ReviewInvestigation of the Occurrence of Serotonin Toxicity in Parkinson's Disease (PD) Patients Treated Concomitantly With Rasagiline and Antidepressants, Using Retrospective Chart ReviewSerotonin SyndromeDrug: Group R+AD Rasagiline + Antidepressant;Drug: Group R Rasagiline;Drug: Group AD Anti-PD + AntidepressantTeva Pharmaceutical IndustriesNULLCompletedN/AN/AAll1500N/AUnited States
1135NCT00955526
(ClinicalTrials.gov)
July 20097/8/2009Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking LevodopaPlacebo-Controlled, Double-Blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)Parkinson's DiseaseDrug: Istradefylline;Drug: PlaceboKyowa Hakko Kirin Company, LimitedNULLCompleted20 YearsN/ABoth373Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1136NCT00918177
(ClinicalTrials.gov)
July 20091/6/2009An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's DiseaseDual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's PatientsParkinson's DiseaseDrug: AP09004;Drug: Carbidopa/Levodopa, immediate releaseIntec Pharma Ltd.NULLCompleted18 YearsN/ABoth72Phase 2Israel
1137NCT00970229
(ClinicalTrials.gov)
July 200931/8/2009Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in PD, HD and Healthy Subjects.Evaluation of [123I]MNI-420 and SPECT as a Marker of the Adenosine A2a Receptor in Subjects With Parkinson Disease, Huntington Disease, and Healthy ControlsParkinson Disease;Huntington DiseaseDrug: [123I]MNI-420Institute for Neurodegenerative DisordersNULLCompleted18 YearsN/AAll19Phase 1United States
1138NCT00955318
(ClinicalTrials.gov)
July 20097/8/2009Long-Term Safety Study of KW-6500 in Patients With Parkinson's DiseasePhase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: KW-6500Kyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll58Phase 3Japan
1139EUCTR2008-004146-88-ES
(EUCTR)
16/06/200916/04/2009A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist.Ensayo de extensión de fase III, doble ciego y controlado con placebo para investigar la eficacia y la seguridad a largo plazo de la safinamida en dosis bajas (50 mg/día) y altas (100 mg/días), como tratamiento añadido en sujetos con enfermedad de Parkinson idiopática temprana que reciben una dosis estable de un único agonista dopaminérgico - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
498Phase 3Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
1140EUCTR2008-001966-10-EE
(EUCTR)
16/06/200913/05/2009A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1141EUCTR2008-008712-98-FR
(EUCTR)
10/06/200928/04/200913-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ056
Other descriptive name: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Other descriptive name: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Other descriptive name: AFQ056
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
234France;Finland;Spain;Germany;Italy
1142EUCTR2009-012529-12-FR
(EUCTR)
10/06/200918/05/2009A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIPA randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: REQUIP-LP
Product Name: ropinirole
Trade Name: REQUIP
Product Name: ropinirole
CHU de ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10France
1143EUCTR2008-004146-88-CZ
(EUCTR)
08/06/200907/04/2009An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonistA phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
1144EUCTR2009-010193-38-LV
(EUCTR)
04/06/200924/08/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
1145NCT00921128
(ClinicalTrials.gov)
June 2, 200913/6/2009Convection-Enhanced Delivery to Study the Pathophysiology Underlying the Clinical Features of Parkinson s DiseaseConvection Enhanced Delivery of Muscimol to Study the Pathophysiology Underlying the Clinical Features of Parkinson's DiseaseParkinson's DiseaseDrug: MuscimolNational Institute of Neurological Disorders and Stroke (NINDS)NULLWithdrawn18 YearsN/AAll0Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1146EUCTR2009-010193-38-LT
(EUCTR)
02/06/200926/03/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
IMPAX Pharmaceuticals a Division of IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
1147NCT02169440
(ClinicalTrials.gov)
June 200924/1/2012Effect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of WarfarinEffect of BIA 9-1067 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Healthy VolunteersParkinson's Disease (PD)Drug: BIA 9-1067;Drug: WarfarinBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Portugal
1148NCT01628926
(ClinicalTrials.gov)
June 200924/6/2012A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease PatientsA Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962;Drug: Ropinirole;Drug: PlaceboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll420Phase 3Japan
1149NCT01519856
(ClinicalTrials.gov)
June 200912/3/2010PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term TherapyEfficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive FunctionParkinson's DiseaseDrug: piribedil (Clarium)Desitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth908N/AGermany
1150NCT01536366
(ClinicalTrials.gov)
June 200923/1/2012Effect of BIA 9-1067 on the Pharmacokinetics of RepaglinideEffect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy VolunteersParkinson DiseaseDrug: BIA 9-1067;Drug: RepaglinideBial - Portela C S.A.NULLCompleted18 Years45 YearsAll27Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1151EUCTR2008-001966-10-AT
(EUCTR)
27/05/200908/04/2009A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
1152EUCTR2008-004146-88-IT
(EUCTR)
26/05/200927/04/2009A phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention StudyA phase III, double-blind, placebo-controlled extension trial toinvestigate the long-term efficacy and safety of low (50 mg/day) andhigh (100 mg/day) dose safinamide, as add-on therapy in subjectswith early idiopathic Parkinson?s disease treated with a stable doseof a single dopamine agonist - MOTION Extention Study Idiopatic Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Safinamide
INN or Proposed INN: Safinamide
Product Name: Safinamide
INN or Proposed INN: Safinamide
MERCK SERONO SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
498Phase 3Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
1153EUCTR2008-001966-10-SK
(EUCTR)
25/05/200928/05/2009A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Other descriptive name: NW-1015
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Estonia;Hungary;Slovakia;Austria;United Kingdom
1154EUCTR2008-004146-88-SK
(EUCTR)
25/05/200928/05/2009A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
1155EUCTR2008-004146-88-FI
(EUCTR)
19/05/200906/04/2009An extension trial to investigate the long-term efficacy and safety of safinamide, as add-on therapy in patients with early Parkinson’s disease treated with a stable dose of a dopamine agonistA phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson’s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
498Phase 3United States;Portugal;Slovakia;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;South Africa;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1156EUCTR2008-008712-98-FI
(EUCTR)
18/05/200908/04/200913-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease moderate to severe levodopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
198Finland;Germany;France;Spain;Italy
1157EUCTR2008-008712-98-IT
(EUCTR)
14/05/200905/05/200913-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease - ND moderate to severe levodopa induced dyskinesia with Parkinson`s disease
MedDRA version: 9.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Code: AFQ056
Product Code: AFQ056
Product Code: AFQ056
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
234Finland;Germany;France;Spain;Italy
1158EUCTR2008-001966-10-GB
(EUCTR)
12/05/200927/04/2009A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
1159EUCTR2008-000400-81-DE
(EUCTR)
11/05/200929/01/2009A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and DyskinesiaA Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia Advanced Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Trade Name: Mirapex
Product Name: pramipexole
INN or Proposed INN: pramipexole
Other descriptive name: pramipexole dihydrochloride monohydrate
Trade Name: Mirapex
Product Name: Pramipexole
INN or Proposed INN: Pramipexole
Other descriptive name: pramipexole dihydrochloride monohydrate
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
50Portugal;Germany;Italy
1160EUCTR2006-000578-53-DE
(EUCTR)
08/05/200930/10/2008Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsOpen-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
Product Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
70United States;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1161EUCTR2009-010193-38-EE
(EUCTR)
07/05/200915/04/2009A Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's DiseaseA Placebo-Controlled Study to Evaluate the Safety and Efficacy of IPX066 in Subjects with Parkinson's Disease Idiopathic Parkinson's disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10034010;Term: Parkinsonism
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
IMPAX Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Estonia;Latvia;Lithuania
1162EUCTR2008-001966-10-HU
(EUCTR)
04/05/200906/04/2009A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
1163EUCTR2007-002963-28-BG
(EUCTR)
03/05/200921/05/2009A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson’s Disease treated with a single dopamine agonist.A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
1164NCT00767546
(ClinicalTrials.gov)
May 20095/10/2008Botulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian PatientsBotulinum Toxin for Treatment of Seborrhic Dermatitis in Parkinsonian PatientsParkinson Disease;Parkinsonism;Seborrheic DermatitisDrug: Botulinum toxinRabin Medical CenterNULLNot yet recruiting18 YearsN/ABoth40Phase 1NULL
1165NCT00902941
(ClinicalTrials.gov)
May 200913/5/2009Olfaction in Patients With Parkinson's Disease Following Treatment With RasagilineReversibility of Olfactory Loss in Patients With Idiopathic Parkinson's Disease Following Treatment With RasagilineParkinson´s DiseaseDrug: Azilect 1mg;Drug: PlaceboTechnische Universität DresdenNULLCompleted18 Years64 YearsBoth34Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1166NCT00907595
(ClinicalTrials.gov)
May 200920/5/2009Treating Sleep/Wake Cycle Disturbances in Basal Ganglia Disorders With RamelteonTreating Sleep Wake Cycle Disturbances in Basal Ganglia Neurodegenerative Disorder Subjects With Ramelteon- A Double Blind, Placebo Controlled TrialHuntington's Disease;Parkinson's Disease;Dementia With Lewy Bodies;Sleep Disorders;Circadian DysregulationDrug: Ramelteon;Drug: PlaceboMassachusetts General HospitalNULLWithdrawn20 Years90 YearsBoth0N/AUnited States
1167NCT00914602
(ClinicalTrials.gov)
May 20093/6/2009An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease SubjectsAn Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: XP21279;Drug: Sinemet®;Drug: Lodosyn®XenoPort, Inc.NULLCompleted30 Years75 YearsBoth14Phase 1;Phase 2United States
1168NCT00906763
(ClinicalTrials.gov)
May 200920/5/2009Effects of Chocolate on Motor Symptoms of Parkinson's DiseaseEffects of Chocolate on Motor Symptoms of Parkinson's Disease - A Monocenter, Prospective, Observer-blinded Interventional TrialParkinson's DiseaseDietary Supplement: ChocolateTechnische Universität DresdenNULLRecruiting18 YearsN/ABoth23N/AGermany
1169NCT00892450
(ClinicalTrials.gov)
May 200928/4/2009Anticholinergic Therapy for Overactive Bladder in Parkinson's DiseaseAnticholinergic Therapy for Overactive Bladder in Parkinson's Disease: A Randomized, Double-blind, Crossover Pilot StudyParkinson's Disease;Overactive BladderDrug: Oxybutynin and darifenacinDepartment of Veterans AffairsNULLCompletedN/AN/ABoth12N/AUnited States
1170NCT01515891
(ClinicalTrials.gov)
May 200919/1/2012Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and MetabolitesAn Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral AdministrationParkinson DiseaseDrug: BIA 9-1067Bial - Portela C S.A.NULLCompleted40 Years55 YearsMale4Phase 1Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1171EUCTR2008-005492-94-IT
(EUCTR)
30/04/200915/04/2009OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND IDIOPATHIC PARKINSON`S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: SAFINAMIDE
Product Code: NW-1015
Product Name: SAFINAMIDE
Product Code: NW-1015
MERCK SERONO SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
1172EUCTR2008-002769-30-IT
(EUCTR)
30/04/200922/04/2009A randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokineticsA randomised, double-blind, placebo-controlled, two-period, two-sequence-crossover interaction study to assess the effect of safinamide on levodopa pharmacokinetics in subjects with Parkinson?s disease - A study to assess the effect of safinamide on levodopa pharmacokinetics Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113
Product Name: Safinamide
INN or Proposed INN: Safinamide
INN or Proposed INN: NACOM levodopa+cardidopa
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
Italy
1173EUCTR2008-008210-38-FR
(EUCTR)
16/04/200919/03/2009Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-IEffet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I Patients ayant une maladie de Parkinson Patients à un stade évolué de la maladie avec des troubles de la marche sévères
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
MedDRA version: 9.1;Level: PT;Term: Parkinson's disease
Trade Name: EBIXA®
Product Name: mémantine
Trade Name: L-Dopa/ MODOPAR
Product Name: L-Dopa
Chru de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28France
1174EUCTR2007-004234-16-AT
(EUCTR)
14/04/200910/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
1175EUCTR2007-001095-36-SK
(EUCTR)
09/04/200909/04/2008The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh StudyThe Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
625Phase 3Hungary;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1176EUCTR2008-005085-30-DE
(EUCTR)
06/04/200904/03/2009Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with RasagilineEinfluss von Rasagilin auf das Riechvermögen von Patienten mit idiopathischem Parkinson-Syndrom(Reversibility of olfactory loss in patients with Idiopathic Parkinson’s disease following treatment with Rasagiline) - Olfaction Idiopathic Parkinson syndrome (IPS), State according to Hoehn & Yahr: maximum III
MedDRA version: 13.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Azilect
INN or Proposed INN: Rasagilin
Technische Universität DresdenNULLNot RecruitingFemale: yes
Male: yes
Germany
1177EUCTR2008-000400-81-PT
(EUCTR)
03/04/200927/01/2009A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and DyskinesiaA Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson’s Disease Experiencing Motor Fluctuations and Dyskinesia Advanced Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Trade Name: Mirapex
Product Name: pramipexole
INN or Proposed INN: pramipexole
Other descriptive name: pramipexole dihydrochloride monohydrate
Trade Name: Mirapex
Product Name: Pramipexole
INN or Proposed INN: Pramipexole
Other descriptive name: pramipexole dihydrochloride monohydrate
Solvay Pharmaceuticals BVNULLNot RecruitingFemale: yes
Male: yes
50Portugal;Germany;Italy
1178EUCTR2007-004235-37-AT
(EUCTR)
02/04/200910/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
1179EUCTR2007-002963-28-PL
(EUCTR)
02/04/200927/02/2009A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as an add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;Czech Republic;Finland;Spain;Poland;Bulgaria;Germany;Italy
1180EUCTR2007-002964-90-AT
(EUCTR)
02/04/200913/02/2008A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
605Phase 3United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1181JPRN-JapicCTI-090888
01/4/2009A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopaA Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa Parkinson's Disease Treated Concomitantly with L-dopaIntervention name : SPM 962
Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day
Control intervention name : Ropinirole
Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day.
Control intervention name : Placebo
Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day.
Otsuka Pharmaceutical Co., Ltd.NULL3079BOTH400Phase 3NULL
1182JPRN-UMIN000001841
2009/04/0102/04/2009A randomized, double blind, comparative study of vitamin D3 versus placebo in patients with Parkinson disease aged between 45 and 85 years old to improve neurological signs and quality of life Parkinson diseaseVitamin D3
placebo
Jikei University School of MedicineNULLComplete: follow-up complete45years-old85years-oldMale and Female120Not selectedJapan
1183NCT00875316
(ClinicalTrials.gov)
April 20092/4/2009Safety and Tolerability Study of Cogane™ in Healthy Volunteers and Parkinson's Disease PatientsA Randomised, Double-blind, Multiple Dose-ascending, Placebo-controlled Study in Healthy Volunteers and Parkinson's Disease Patients to Assess the Safety, Tolerability and PK of Daily Oral Administration of Cogane™ Over One MonthParkinson's DiseaseDrug: Cogane™ (PYM50028)PhytopharmNULLCompleted40 Years80 YearsBoth36Phase 1United Kingdom
1184NCT00865579
(ClinicalTrials.gov)
April 200910/3/2009Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease PatientsParkinson's DiseaseDrug: SafinamideNewronNULLTerminated30 YearsN/AAll964Phase 3Romania
1185NCT00880620
(ClinicalTrials.gov)
April 20093/4/2009A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's DiseaseA Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll381Phase 3United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1186NCT01568034
(ClinicalTrials.gov)
April 200929/3/2012A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067A Double-blind, Randomised, Placebo-controlled, Cross-over Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 on the Levodopa Pharmacokinetics, Motor Response, and Erythrocyte Soluble Catechol-O-methyltransferase Activity in Parkinson's Disease Patients Concomitantly Treated With Levodopa/Dopa-decarboxylase InhibitorParkinson's DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: Levodopa/Carbidopa;Drug: Levodopa/BenzerazideBial - Portela C S.A.NULLCompleted30 Years75 YearsAll10Phase 2Portugal;Romania;Ukraine
1187EUCTR2008-000400-81-IT
(EUCTR)
31/03/200917/04/2009A Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - NDA Multicenter, Randomized, Double Blind, Pramipexole Controlled Pilot Study to Assess Efficacy and Safety of Pardoprunox as Adjunct Therapy to L-dopa in the Treatment of Patients with Parkinson?s Disease Experiencing Motor Fluctuations and Dyskinesia - ND Advanced Parkinson`s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Trade Name: Mirapex
INN or Proposed INN: Pramipexole
Trade Name: Mirapex
INN or Proposed INN: Pramipexole
Trade Name: Mirapex
INN or Proposed INN: Pramipexole
SOLVAY PHARMACEUTICALS B.V.NULLNot RecruitingFemale: yes
Male: yes
50Portugal;Germany;Italy
1188EUCTR2007-003035-22-AT
(EUCTR)
30/03/200926/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
560Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
1189EUCTR2008-004447-11-GB
(EUCTR)
27/03/200907/01/2009A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s DiseaseA Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
MedDRA version: 11;Level: LLT;Classification code 10067209;Term:
Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2bGermany;United Kingdom;Italy
1190EUCTR2007-002963-28-PT
(EUCTR)
26/03/200907/01/2009A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonistA phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A-GenevaNULLNot RecruitingFemale: yes
Male: yes
1036Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1191EUCTR2007-002964-90-FR
(EUCTR)
09/03/200912/11/2007A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1121Phase 3Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
1192NCT01533116
(ClinicalTrials.gov)
March 200924/1/2012Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/BenserazideEffect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazideBial - Portela C S.A.NULLCompleted25 Years45 YearsAll52Phase 1Canada
1193NCT00888004
(ClinicalTrials.gov)
March 200923/4/2009Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease PatientsA Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced DyskinesiasParkinson's Disease;L-dopa Induced DyskinesiaDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years85 YearsBoth28Phase 2Germany
1194NCT00823836
(ClinicalTrials.gov)
March 200915/1/2009Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's DiseaseClinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's DiseaseParkinson DiseaseDrug: ropinirole PR/XR;Drug: ropinirole IRGlaxoSmithKlineNULLCompleted20 YearsN/AAll302Phase 3Japan
1195NCT01533077
(ClinicalTrials.gov)
March 200924/1/2012Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/CarbidopaPharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Sinemet® 100/25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll18Phase 1Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1196NCT00767091
(ClinicalTrials.gov)
March 20091/9/2008Study of Rivastigmine to Treat Parkinsonian Apathy Without DementiaA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicentric TrialParkinson's Disease;Apathy;no DementiaDrug: rivastigmine;Drug: placeboUniversity Hospital, LilleNULLCompleted15 Years80 YearsBoth40Phase 3France
1197NCT01399905
(ClinicalTrials.gov)
March 200921/7/2011High and Low Dose Carbidopa Treatment of Parkinson's DiseaseA Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa.Parkinson's DiseaseDrug: carbidopaOregon Health and Science UniversityNULLCompleted35 Years85 YearsAll14Phase 2United States
1198NCT00940914
(ClinicalTrials.gov)
March 200916/7/2009Dopaminergic Loss and Pain in Parkinson's DiseaseEvaluation of Radioligand Uptake (FP-CIT) of Dopamine Transporters in Patients Suffering From Parkinson's Disease With or Without PainParkinson's Disease;PainDrug: ioflupane 123I (DATSCAN®)University Hospital, ToulouseNULLCompleted30 Years70 YearsAll20Phase 2France
1199NCT00870974
(ClinicalTrials.gov)
March 200926/3/2009A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric ConditionsEvaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric ConditionsParkinson Disease;Huntington Disease;Autistic Spectrum Disorders;Fragile X Syndrome;Alzheimer Disease;Mild Cognitive ImpairmentDrug: [18F]FPEBInstitute for Neurodegenerative DisordersNULLCompleted18 Years85 YearsAll48Phase 1United States
1200EUCTR2006-005186-18-CZ
(EUCTR)
09/02/200921/11/2007Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
Product Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1201EUCTR2008-006278-13-NL
(EUCTR)
04/02/200915/10/2008Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations.Motor function optimization in advanced Parkinson’s disease patients, combined with galantamine to prevent visual hallucinations. patients with advanced (>5 years) Parkinson's disease and visual hallucinations.
MedDRA version: 9.1;Level: LLT;Classification code 10047570;Term: Visual hallucinations
MedDRA version: 9.1;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Reminyl Retard
Trade Name: Sinemet 125 mg
UMCGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Netherlands
1202NCT00873392
(ClinicalTrials.gov)
February 200931/3/2009Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's DiseaseEfficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease(One Daily Administration).A Controlled Randomised Study, in Two Parallel Groups and Single Blind in 40 Patients.Idiopathic Parkinson's DiseaseDrug: Transdermal nicotine;Other: Usual drug treatment of Parkinson's diseaseAssistance Publique - Hôpitaux de ParisNULLCompleted35 Years70 YearsBoth40Phase 2France
1203NCT00627640
(ClinicalTrials.gov)
February 200913/2/2008Safinamide in Idiopathic Parkinson's Disease (IPD) With Motor Fluctuations, as add-on to LevodopaA Phase III, Double-blind, Placebo-controlled, Randomised Trial to Determine the Efficacy and Safety of a Dose Range of 50 to 100 mg/Day of Safinamide, as add-on Therapy, in Subjects With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, an Anticholinergic and/or AmantadineIdiopathic Parkinson's DiseaseDrug: Safinimide 50-100 mg/day;Drug: Matching PlaceboNewronNULLCompleted30 Years80 YearsBoth549Phase 3United States;Australia;Austria;Belgium;Canada;Estonia;France;Germany;Hungary;India;Israel;Korea, Republic of;Malaysia;Netherlands;New Zealand;Slovakia;Spain;Switzerland;Taiwan;Thailand;United Kingdom
1204NCT00806468
(ClinicalTrials.gov)
February 20099/12/2008Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson DiseaseA Double Blind, Placebo Controlled, Randomized, Monocentre Cross-over Study to Investigate the Effect of Desmopressin on the Nocturnal Micturition Frequency in Patients With Parkinson DiseaseParkinson DiseaseDrug: DesmotabsJohannes Gutenberg University MainzNULLTerminated18 Years85 YearsMale1Phase 4Germany
1205NCT01039090
(ClinicalTrials.gov)
February 200922/12/2009Efficacy of Continuous Apomorphine Infusion on Cognitive and Neuropsychological Functions in Parkinson's DiseaseProspective, Randomised, Comparative Study Comparing Efficacy of Continuous Apomorphine Infusion Versus Usual Dopaminergic Per os Treatment on Cognitive and Neuropsychological Functions in Parkinson's Disease: a Clinical and PET-scan StudyParkinsons's DiseaseDrug: Continuous Apomorphine infusion;Drug: Usual dopaminergic per os treatmentRennes University HospitalNULLCompleted18 YearsN/AAll21Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1206EUCTR2007-007853-30-SE
(EUCTR)
28/01/200921/12/2007A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump.A randomized, double-blind, placebo controlled, safety and tolerability study of intracerebroventricular administration of sNN0031 to patients with idiopathic Parkinson's disease (PD) of moderate severity, using an implanted catheter and a SynchroMed® II pump. Idiopathic Parkinson's disease (PD) of moderate severity (modified Hoehn & Yahr Stage IIb - III)Product Name: sNN0031
Product Code: sNN0031
NeuroNova ABNULLNot RecruitingFemale: yes
Male: yes
Sweden
1207EUCTR2009-015833-66-IT
(EUCTR)
20/01/200918/04/2012Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate releaseRopinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release Parkinson's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: REQUIP*28CPR 8MG R.P.
INN or Proposed INN: ROPINIROLE
Other descriptive name: NA
Trade Name: REQUIP*21CPR 5MG
INN or Proposed INN: ROPINIROLE
Other descriptive name: NA
Trade Name: MIRAPEXIN*30CPR 0,7MG
INN or Proposed INN: PRAMIPEXOLE
Other descriptive name: NA
CASA DI CURA PRIVATA S.RAFFAELE - PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
1208EUCTR2007-002963-28-CZ
(EUCTR)
19/01/200930/10/2007A trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Peru;Bulgaria;South Africa;Germany
1209EUCTR2007-003035-22-PT
(EUCTR)
09/01/200901/07/2008A safety and tolerability study of ACP-103 in patients with Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease
MedDRA version: 18.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ACADIA Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
400Phase 3Portugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
1210EUCTR2007-003035-22-IT
(EUCTR)
07/01/200923/07/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease - ACP-103-015 Psychosis in Parkinson?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: primavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: primavanserin tartrate
ACADIA PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
486Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1211EUCTR2008-004906-15-FR
(EUCTR)
05/01/200916/03/2009EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de ParkinsonEVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson Maladie de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DATSCANCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
1212NCT02169466
(ClinicalTrials.gov)
January 200920/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/BenserazidePharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBSBial - Portela C S.A.NULLCompleted18 Years45 YearsMale22Phase 1Portugal
1213EUCTR2004-000148-26-AT
(EUCTR)
31/12/200826/11/2008A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/AA multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Schwarz BioSciences Inc.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden
1214EUCTR2008-003966-25-DE
(EUCTR)
23/12/200804/11/2008Double-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPADouble-blind, placebo controlled, randomised, monocenter cross-over studie to evaluate the effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome compared to placebo. - DEPOPA Effect of Desmopressin on the nocturnal polyuria in patients with idiopathic Parkinson Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10064016;Term: Nocturnal polyuria
MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease
Trade Name: Desmotabs® 0,2 mg Tabletten
Product Name: Desmotabs® 0,2mg Tabletten
INN or Proposed INN: Desmopressin Acetat
Universität Mainz, Klinik und Poliklinik für NeurologieNULLNot RecruitingFemale: no
Male: yes
20Germany
1215NCT00809302
(ClinicalTrials.gov)
December 200815/12/2008Efficacy and Safety Study of Aplindore in Patients With Early Parkinson DiseaseA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg Twice Daily) in Patients With Early Parkinson Disease (APLIED)Early Parkinson DiseaseDrug: aplindore MR tablets or PlaceboNeurogen CorporationNULLTerminated30 YearsN/ABoth9Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1216EUCTR2008-004943-12-SK
(EUCTR)
24/11/200810/10/2008The Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens StudyThe Rubens Study:A Multicenter, Randomized, Double-blind, Parallel Group, Placebo and Pramipexole Controlled Study to Explore the Efficacy, Tolerability and Safety of Different Doses and Titration Schedules of Pardoprunox Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rubens Study Early Stage Parkinson’s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Other descriptive name: SLV308 hydrochloride
Trade Name: Mirapex
INN or Proposed INN: Pramipexole
Other descriptive name: pramipexole dihydrochloride monohydrate
Solvay Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
320Phase 2Slovakia
1217EUCTR2006-005186-18-GB
(EUCTR)
19/11/200827/06/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Abbott Healthcare Products B.V.NULLNot Recruiting Female: yes
Male: yes
320Phase 3Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
1218EUCTR2007-006721-27-GB
(EUCTR)
11/11/200825/02/2009A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: CERE-120
Product Code: CERE-120
Ceregene Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
1219EUCTR2007-003051-36-BE
(EUCTR)
06/11/200821/05/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280Austria;Sweden;Portugal;Spain;Belgium
1220EUCTR2007-003035-22-GB
(EUCTR)
05/11/200820/12/2007 A safety and tolerability study of ACP-103 in patients with Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015 Psychosis in Parkinson's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ACADIA Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
400Phase 3United States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1221NCT00869791
(ClinicalTrials.gov)
November 200824/3/2009A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaA Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll27Phase 2United States
1222NCT00629161
(ClinicalTrials.gov)
November 200825/2/2008Clinical Trial on the Effectiveness of Traditional Chinese Medicinal Mixture in Parkinson DiseaseParkinson DiseaseDrug: Traditional Chinese Medicinal Mixture (composed of Roucongrong and adjuvant);Drug: placeboFudan UniversityNULLRecruiting50 YearsN/ABoth144Phase 2;Phase 3China
1223EUCTR2007-006721-27-AT
(EUCTR)
20/10/200815/09/2008A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease.A Phase II, Multicenter, Randomized and Controlled Open-Label Trial Comparing the Safety and Efficacy of Bilateral Intraputaminal (IPu) Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) Combined with Best Medical Therapy (BMT) versus BMT-alone in Subjects With Idiopathic Parkinson’s Disease. idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: CERE-120
Product Code: CERE-120
Ceregene Inc.NULLNot RecruitingFemale: yes
Male: yes
50Phase 2Austria;United Kingdom
1224EUCTR2007-004890-24-PT
(EUCTR)
07/10/200825/06/2008A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHNA Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy
Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets
Product Code: JP-1730/F01
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets
Product Code: JP-1730/F02
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets
Product Code: JP-1730/F03
INN or Proposed INN: Fipamezole hydrochloride
Juvantia Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Portugal;France
1225EUCTR2008-003869-72-PT
(EUCTR)
03/10/200825/06/2008A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITORA DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, CROSS-OVER STUDY TO INVESTIGATE THE TOLERABILITY AND EFFECT OF THREE SINGLE-DOSE REGIMENS OF BIA 9-1067 ON THE LEVODOPA PHARMACOKINETICS, MOTOR RESPONSE, AND ERYTHROCYTE SOLUBLE CATECHOL-O-METHYLTRANSFERASE ACTIVITY IN PARKINSON'S DISEASE PATIENTS CONCOMITANTLY TREATED WITH LEVODOPA/DOPA-DECARBOXYLASE INHIBITOR Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Code: BIA 9-1067
Trade Name: SINEMET 25/100
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Product Code: BIA 9-1067
Bial - Portela & Cª, S.A.NULLNot RecruitingFemale: yes
Male: yes
12Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1226EUCTR2007-000350-31-IT
(EUCTR)
02/10/200811/02/2008A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - NDA 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND mild to moderately severe dementia associated with Parkinson?s disease (PDD)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Exelon path transdermal
Product Code: ENA713B
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Product Name: Exelon path transdermal
Product Code: ENA713B
INN or Proposed INN: Rivastigmine
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
550France;Spain;Italy
1227EUCTR2007-004235-37-IT
(EUCTR)
02/10/200828/11/2007Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - NDLong-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND Patients with advanced idiopathic PD
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
1228NCT02169453
(ClinicalTrials.gov)
October 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/CarbidopaPharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25Bial - Portela C S.A.NULLCompleted18 Years45 YearsMale12Phase 1Canada
1229NCT02092168
(ClinicalTrials.gov)
October 200820/1/2012Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects and in Healthy Male Young SubjectsSingle-dose and Steady-state Pharmacokinetics of BIA 9-1067 and Its Metabolites in Healthy Male Elderly Subjects Compared With Those in Healthy Male Young SubjectsParkinson DiseaseDrug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 YearsN/AMale24Phase 1France
1230NCT01048229
(ClinicalTrials.gov)
October 200812/1/2010Evaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's DiseaseEvaluation of the Tolerance and Acceptability of Rasagiline in the Treatment of Early-stage Parkinson's DiseaseEarly-stage Parkinson's DiseaseDrug: Rasagiline;Drug: PramipexoleQualissimaH. Lundbeck A/STerminated18 Years70 YearsBoth112Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1231EUCTR2006-005186-18-DE
(EUCTR)
30/09/200813/11/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
Product Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
1232EUCTR2007-003051-36-AT
(EUCTR)
10/09/200829/04/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
1233EUCTR2008-003225-16-FI
(EUCTR)
10/09/200830/05/2008Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilaillaAivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla Vaikeahoitoinen Parkinsonin tauti potilailla, joille on aiemmin asetettu aivostimulaattori, tai on päädytty päivittäisten oireiden vuoksi aloittamaan Duodopa-infuusio.
MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS
Trade Name: DuodopaOrganisation name was not enteredNULLNot RecruitingFemale: yes
Male: yes
Finland
1234EUCTR2007-003051-36-PT
(EUCTR)
05/09/200827/05/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
1235EUCTR2007-003035-22-BE
(EUCTR)
02/09/200821/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: pimavanserin (ACP-103)
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1236NCT00755027
(ClinicalTrials.gov)
September 200817/9/2008Rasagiline and Apathy in Parkinson's DiseaseA Randomised Placebo-controlled Trial of Rasagiline in Parkinson Disease Patients With Symptoms of ApathyParkinson's DiseaseDrug: RasagilineFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauNULLCompleted18 Years80 YearsBoth40Phase 4Spain
1237NCT02169895
(ClinicalTrials.gov)
September 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/BenserazidePharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa®Bial - Portela C S.A.NULLCompleted25 Years45 YearsMale16Phase 1Canada
1238NCT02169479
(ClinicalTrials.gov)
September 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/CarbidopaPharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25Bial - Portela C S.A.NULLCompleted18 Years45 YearsMale16Phase 1Canada
1239EUCTR2007-004235-37-GB
(EUCTR)
19/08/200826/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
1240EUCTR2004-005234-39-DE
(EUCTR)
11/08/200802/12/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;United Kingdom;Germany;Denmark;Ireland;Latvia;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1241NCT00601978
(ClinicalTrials.gov)
August 200811/1/2008Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing OffA 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing OffParkinson's DiseaseDrug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/EntacaponeNovartis PharmaceuticalsNULLWithdrawn45 Years75 YearsBoth0Phase 4United States
1242EUCTR2004-000148-26-HU
(EUCTR)
26/07/200819/07/2004A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/AA multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Schwarz BioSciences Inc.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Finland;Hungary;Czech Republic;Spain;Italy;Sweden
1243EUCTR2008-003581-26-SE
(EUCTR)
18/07/200830/05/2008Pharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMTPharmacokinetics of levodopa using duodenal levodopa/carbidopa infusion with and without oral COMT inhibitors - DuoCOMT Parkinson's disease (G20.9), advanced, patients presently on Duodopa treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Duodopa
INN or Proposed INN: levodopa
INN or Proposed INN: carbidopa
Trade Name: Comtess
INN or Proposed INN: entacapone
Trade Name: Tasmar
INN or Proposed INN: tolcapone
Dept of Neuroscience, Uppsala UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Sweden
1244EUCTR2008-001336-13-FR
(EUCTR)
16/07/200809/06/2008Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2Effet de la Nicotine transdermique sur les symptomes moteurs de la maladie de Parkinson avancée (une administration quotidienne) .Etude contrôlée, randomisée, en deux groupes parallèles et en simple insu sur 40 patients. - NICOPARK2 Maladie Parkinson
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Nicorette 5 mg/ 16 h
Product Name: Nicorette 5 mg/ 16 h
INN or Proposed INN: Nicotine
Product Name: Nicorette 10mg/ 16 h
INN or Proposed INN: Nicotine
Product Name: Nicorette 15 mg/ 16 h
INN or Proposed INN: Nicotine
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
1245EUCTR2007-003051-36-ES
(EUCTR)
01/07/200805/05/2008Ensayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseEnsayo multicéntrico, doble ciego y controlado con placebo para evaluar la seguridad y la eficacia de ACP-103 en el tratamiento de la psicosis en la enfermedad de Parkinson.A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psicosis en la enfermedad de Parkinson.Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1246EUCTR2007-003051-36-SE
(EUCTR)
30/06/200816/05/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280Portugal;Spain;Austria;Sweden
1247EUCTR2007-002963-28-IT
(EUCTR)
30/06/200804/01/2008A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonistA phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson?s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: safinamide
Product Name: safinamide
MERCK SERONO INTERNATIONAL SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
666Phase 3Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
1248EUCTR2007-003134-42-DE
(EUCTR)
19/06/200820/02/2008A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. Idiopathic Parkinson’s disease and end-of-dose wearing off.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten
Product Name: Stalevo
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONE
Trade Name: Nacom 100
Product Name: Nacom
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
20Germany
1249EUCTR2007-003035-22-SE
(EUCTR)
11/06/200816/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: pimavanserin (ACP-103)
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
1250EUCTR2007-002964-90-HU
(EUCTR)
03/06/200815/11/2007A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A.-GenevaNULLNot RecruitingFemale: yes
Male: yes
1121Phase 3France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1251NCT00822913
(ClinicalTrials.gov)
June 200814/1/2009Botulinum A Toxin in Patients With Parkinson's DiseaseThe Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.Parkinson's Disease;Multiple System Atrophy;Detrusor OveractivityDrug: Intravesical injection of Botulinum A toxinUniversity Of PerugiaUniversity of Roma La SapienzaEnrolling by invitation18 Years80 YearsBoth20Phase 4NULL
1252EUCTR2007-004235-37-PL
(EUCTR)
29/05/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden
1253EUCTR2007-004009-93-IT
(EUCTR)
20/05/200814/07/2008Prevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopramPrevalence of depression,anxiety and impulse control disorder (ICD) in patients with Parkinson's disease and effectiveness of escitalopram Depression, anxiety and ICD
MedDRA version: 14.1;Level: SOC;Classification code 10037175;Term: Psychiatric disorders;System Organ Class: 10037175 - Psychiatric disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: CIPRALEX
INN or Proposed INN: Escitalopram
Trade Name: CIPRALEX
INN or Proposed INN: Escitalopram
LUNDBECK ITALIANULLNot RecruitingFemale: yes
Male: yes
Italy
1254EUCTR2007-004890-24-FR
(EUCTR)
07/05/200809/05/2008A Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHNA Phase II, Randomised, Placebo-Controlled, Double-Blind, Replicated Crossover, Pilot Study on the Effect of Fipamezole on Neurogenic Orthostatic Hypotension in Patients with Multiple System Atrophy or Parkinson’s Disease - FOEHN Neurogenic orthostatic hypotension in patients with multiple system atrophy or Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
MedDRA version: 9.1;Classification code 10064060;Term: Multiple system atrophy
Product Name: Fipamezole hydrochloride 90 mg oral disintegrating tablets
Product Code: JP-1730/F01
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 60 mg oral disintegrating tablets
Product Code: JP-1730/F02
INN or Proposed INN: Fipamezole hydrochloride
Product Name: Fipamezole hydrochloride 30 mg oral disintegrating tablets
Product Code: JP-1730/F03
INN or Proposed INN: Fipamezole hydrochloride
Juvantia Pharma LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Portugal;France
1255EUCTR2006-006752-35-DE
(EUCTR)
06/05/200823/03/2007RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVERRECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RECOVER Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24 h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24 h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1256NCT01416818
(ClinicalTrials.gov)
May 200811/8/2011Treatment of Depression in Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled Study of Xiaoyao Pill Treatment of Depression in Patients With Parkinson's DiseaseDepression in Parkinson's DiseaseDrug: Xiaoyao Pill;Drug: Bupleurum+Ginkgo;Drug: placeboXuanwu Hospital, BeijingNULLRecruiting30 Years80 YearsBoth60Phase 2China
1257EUCTR2007-004235-37-SE
(EUCTR)
23/04/200825/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
1258EUCTR2007-002906-23-BG
(EUCTR)
16/04/200807/07/2008A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280United Kingdom;France;Bulgaria
1259EUCTR2007-004234-16-FI
(EUCTR)
16/04/200812/02/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
520Hungary;Finland;Czech Republic;Netherlands;France;Austria
1260EUCTR2007-001096-10-SK
(EUCTR)
11/04/200809/04/2008An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh StudyAn Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1261NCT00651183
(ClinicalTrials.gov)
April 200831/3/2008Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentNon-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentParkinson DiseaseDrug: Pramipexole immediate releaseBoehringer IngelheimNULLCompleted18 YearsN/AAll286Austria
1262NCT02071810
(ClinicalTrials.gov)
April 200819/1/2012Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Tolerability, Pharmacokinetics and Pharmacodynamics of Four Multiple Rising Dose Regimens of BIA 9-1067 in Healthy Male VolunteersParkinson's Disease (PD)Drug: BIA 9-1067;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsMale34Phase 1France
1263NCT00605553
(ClinicalTrials.gov)
April 200815/1/2008Study to Evaluate SYN115 in Parkinson's DiseaseA Randomized, Double-blind, Placebo Controlled, Two-way Cross-over Study to Explore the Effects of 7 Days of Dosing With SYN115 20 mg p.o. BID or 60 mg p.o. BID on Clinical and fMRI Response to Intravenous Levodopa in Patients With Mild to Moderate Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: TozadenantBiotie Therapies Inc.NULLCompleted40 Years75 YearsAll30Phase 2United States
1264EUCTR2006-003732-30-PL
(EUCTR)
27/03/200808/01/2008Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 Early Parkinson's Disease
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Product Name: Lisuride TTS 10cm²
INN or Proposed INN: LISURIDE
Trade Name: Sifrol 0,088
INN or Proposed INN: PRAMIPEXOLE
Product Name: Lisuride TTS 20cm²
INN or Proposed INN: LISURIDE
Trade Name: Sifrol 0,18
INN or Proposed INN: PRAMIPEXOLE
Trade Name: Sifrol 0,35
INN or Proposed INN: PRAMIPEXOLE
Trade Name: Sifrol 0,7
INN or Proposed INN: PRAMIPEXOLE
NeuroBiotec Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Germany;Italy;Poland
1265EUCTR2007-001095-36-HU
(EUCTR)
27/03/200806/02/2008The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh StudyThe Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
625Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1266EUCTR2007-005033-11-DE
(EUCTR)
27/03/200804/01/2008A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s DiseaseA Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease Patients with Parkinson's DiseaseProduct Name: Levodopa-Carbidopa Multilayer Extended Release Tablet
Product Code: Levodopa-Carbidopa XL tablet (M)
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet® CR
Product Name: Sinemet CR
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
Germany
1267EUCTR2007-001096-10-HU
(EUCTR)
27/03/200815/02/2008An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh StudyAn Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
500Hungary
1268EUCTR2007-002964-90-GB
(EUCTR)
20/03/200814/01/2009 A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Merck Serono S.A - GenevaNULLNot Recruiting Female: yes
Male: yes
605Phase 3France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
1269EUCTR2007-004235-37-HU
(EUCTR)
17/03/200817/01/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
1270EUCTR2007-004234-16-HU
(EUCTR)
17/03/200817/01/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1271EUCTR2006-005186-18-PT
(EUCTR)
07/03/200814/11/2007An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
1272NCT00658567
(ClinicalTrials.gov)
March 200810/4/2008A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll123Phase 3United States;Austria;Belgium;Italy;Poland;Portugal;Serbia;Spain;Sweden
1273NCT00642356
(ClinicalTrials.gov)
March 200819/3/2008Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffAn 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartisNULLTerminated30 Years85 YearsAll14Phase 4United States
1274NCT00607451
(ClinicalTrials.gov)
March 200822/1/2008Safety, Tolerability, PK and PD Study of Neu-120 in the Treatment of Levodopa-induced DyskinesiaA Double-blind, Placebo Controlled, Crossover, Ascending Single Dose Safety Tolerability, Pharmacokinetic and Pharmacodynamic Study of Neu-120 in Patients With Advanced Phase Idiopathic Parkinson's Disease With Levodopa Induced DyskinesiaLevodopa-induced DyskinesiaDrug: Neu-120Neurim Pharmaceuticals Ltd.NULLTerminated30 Years80 YearsAll8Phase 1;Phase 2Israel
1275NCT00727727
(ClinicalTrials.gov)
March 200831/7/2008SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices.Parkinson's DiseaseDrug: PiribedilDesitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth750N/AGermany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1276EUCTR2007-003035-22-FR
(EUCTR)
29/02/200815/02/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Acadia Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
486Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
1277EUCTR2007-002964-90-DE
(EUCTR)
28/02/200817/12/2008A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
484Phase 3France;Czech Republic;Estonia;Hungary;Finland;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom
1278EUCTR2007-002964-90-EE
(EUCTR)
13/02/200802/01/2008A trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in patients with Parkinson’s Disease with motor fluctuations, treated with levodopa and who may be receiving a dopamine agonist, an anticholinergic and/or amantadine.A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
605Phase 3United States;Estonia;Taiwan;Finland;Spain;Thailand;Austria;Israel;United Kingdom;Switzerland;India;France;Czech Republic;Hungary;Canada;Malaysia;Belgium;Australia;Germany;Netherlands;New Zealand;Korea, Republic of
1279EUCTR2007-000350-31-ES
(EUCTR)
13/02/200821/12/2007Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP)Estudio prospectivo, multicéntrico y en condiciones abiertas de 76 semanas de duración para evaluar el efecto a largo plazo de Exelon® cápsula y parche transdérmico en el empeoramiento de los síntomas motores subyacentes de la EP en pacientes con demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP) Demencia leve a moderadamente grave asociada a enfermedad de Parkinson (DEP).
MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon 4.6 mg/24 h transdermal patch
INN or Proposed INN: rivastigmine
Trade Name: Exelon 9.5 mg/24 h transdermal patch
INN or Proposed INN: rivastigmine
Novartis Farmacéutica S.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550France;Spain;Italy
1280EUCTR2006-005186-18-IT
(EUCTR)
08/02/200814/11/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Duodopa gel intestinale
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals BV.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1281EUCTR2007-002195-34-FR
(EUCTR)
04/02/200807/12/2007Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups.Evaluation of the effect of 6 months treatment with DC158AM on fatigue in patients with Parkinson’s disease. Multicentre, randomised, double-blind, placebo-controlled study in parallel groups. Fatigue symptoms in Parkinson's disease.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
PIERRE FABRE MEDICAMENTNULLNot Recruiting Female: yes
Male: yes
120Phase 3France
1282NCT02236728
(ClinicalTrials.gov)
February 200810/9/2014Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With PramipexoleObservational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)Parkinson DiseaseDrug: PramipexoleBoehringer IngelheimNULLCompletedN/AN/ABoth497N/ANULL
1283NCT00624741
(ClinicalTrials.gov)
February 200815/2/2008Compassionate Use Study of Pergolide in Patients With Parkinson's DiseaseCompassionate Use of Pergolide as Adjunctive Therapy to Levodopa/Carbidopa for Treating Parkinson's DiseaseParkinson DiseaseDrug: PergolideValeant Pharmaceuticals International, Inc.NULLNo longer availableN/AN/ABothN/ANULL
1284EUCTR2007-002467-27-GB
(EUCTR)
24/01/200826/11/2007Antidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramateAntidyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients with Parkinson's Disease and Levodopa-Induced Dyskinesias - Antidyskinetic properties of topiramate Patients with idiopathic Parkinson's disease and levodopa-induced dyskinesias
MedDRA version: 13.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 13.1;Classification code 10061536;Term: Parkinson's disease;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 10029205 - Nervous system disorders
Product Name: Topiramate
INN or Proposed INN: TOPIRAMATE
Salford Royal NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
1285EUCTR2007-004235-37-ES
(EUCTR)
24/01/200808/03/2010Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1286EUCTR2006-005186-18-ES
(EUCTR)
23/01/200829/11/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas - Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Solvay Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
1287EUCTR2007-000350-31-FR
(EUCTR)
22/01/200825/10/2007A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD).A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon® capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson’s disease (PDD). Mild to moderately severe dementia associated with Parkinson’s disease (PDD).
MedDRA version: 9.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon
INN or Proposed INN: rivastigmine
Trade Name: Exelon 4.6 mg/24 h transdermal patch
INN or Proposed INN: rivastigmine
Trade Name: Exelon 9.5 mg/24 h transdermal patch
INN or Proposed INN: rivastigmine
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
550France;Spain;Italy
1288EUCTR2007-004235-37-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden
1289EUCTR2007-004234-16-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
1290EUCTR2006-006752-35-IT
(EUCTR)
21/01/200824/04/2007PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVERPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON S DISEASE - RECOVER Idiopathic Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro
Trade Name: Neupro
Trade Name: Neupro
Trade Name: Neupro
SCHWARZ PHARMANULLNot RecruitingFemale: yes
Male: yes
336Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1291EUCTR2007-002964-90-ES
(EUCTR)
18/01/200830/11/2007A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine.Ensayo fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de un rango de dosis de 50 - 100 mg/día de safinamida, como terapia añadida, en pacientes con enfermedad de Parkinson idiopática con fluctuaciones motoras tratados con una dosis estable de levodopa y que podrían estar recibiendo tratamiento concomitante con dosis estables de un agonista de la dopamina, un anticolinérgico y/o amantadina. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Ideopathic Parkinson's Disease Enfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1121Phase 3Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
1292EUCTR2007-002963-28-ES
(EUCTR)
17/01/200816/11/2007A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonistA phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist.Ensayo en fase III aleatorizado, doble ciego y controlado con placebo, para determinar la eficacia y la seguridad de una dosis baja (50 mg/día) y una alta (100 mg/día) de safinamida, como terapia añadida en pacientes con enfermedad de Parkinson idiopática precoz tratados con una dosis estable de un único agonista de la dopamina. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's DiseaseEnfermedad de Parkinson Idiopática
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1036Phase 3Portugal;Finland;Germany;Czech Republic;Bulgaria;Spain;Italy;Poland
1293EUCTR2007-004234-16-SK
(EUCTR)
14/01/200818/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 3France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
1294EUCTR2007-004235-37-SK
(EUCTR)
14/01/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
1295EUCTR2007-004234-16-FR
(EUCTR)
11/01/200819/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
BOEHRINGER INGELHEIMNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1296NCT00725478
(ClinicalTrials.gov)
January 200828/7/2008SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's DiseaseStabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.Parkinson's DiseaseDrug: PiribedilDesitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth250N/ANULL
1297NCT00608231
(ClinicalTrials.gov)
January 20087/1/2008Dexmedetomidine Effects on Microelectrode Recording in Deep Brain StimulationDexmedetomidine Effects on Microelectrode Recording in Deep Brain StimulationParkinson's Disease;Essential Tremor;DystoniaDrug: Dexmedetomidine Hydrochloride Infusion;Drug: Normal SalineVanderbilt UniversityNULLWithdrawn18 YearsN/ABoth0Phase 2;Phase 3United States
1298NCT00623103
(ClinicalTrials.gov)
January 200814/2/2008Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)Parkinson's Disease DementiaDrug: Rivastigmine capsule;Drug: Rivastigmine transdermal patchNovartisNULLCompleted50 Years85 YearsAll583Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom
1299NCT00600093
(ClinicalTrials.gov)
January 200813/1/2008Perioperative Treatment of Parkinsonian Patients With Parenteral AmantadinePerioperative Treatment of Parkinsonian Patients With Parenteral AmantadineParkinson Disease;Perioperative CareDrug: AmantadineRabin Medical CenterNULLTerminatedN/AN/ABoth20Phase 2Israel
1300NCT00627588
(ClinicalTrials.gov)
January 200831/1/2008Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's DiseaseA Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease.Parkinson's DiseaseBiological: ProSavinOxford BioMedicaNULLCompleted48 Years65 YearsBoth15Phase 1;Phase 2France;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1301NCT00623324
(ClinicalTrials.gov)
January 200814/2/2008The Effects of Aplindore on the Treatment of Signs and Symptoms of Parkinson's DiseaseA Phase II, Dose Ranging, Randomized, Double Blind, Placebo-controlled, Multi-center, Pilot Study to Assess the Safety, Tolerability, Efficacy and Pharmacokinetics of Aplindore in Patients With Early Stage Parkinson's DiseaseEarly Stage Parkinson's DiseaseDrug: Aplindore;Drug: PlaceboLigand PharmaceuticalsNULLCompleted30 YearsN/ABoth40Phase 2United States
1302NCT00612872
(ClinicalTrials.gov)
January 200816/1/2008Evaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With PD or AD and in Healthy SubjectsEvaluation of [123I]CLINDE and SPECT as a Marker of Inflammation in Subjects With Parkinson Disease or Alzheimer Disease and in Healthy SubjectsParkinson Disease;Alzheimer Disease;Healthy Controls;Multiple SclerosisDrug: [123I]CLINDEInstitute for Neurodegenerative DisordersNULLTerminated30 Years50 YearsAll46Phase 1United States
1303NCT01628965
(ClinicalTrials.gov)
January 200825/6/2012A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll143Phase 2;Phase 3Japan
1304NCT00601523
(ClinicalTrials.gov)
January 200815/1/2008Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Parkinson DiseaseDrug: Placebo;Drug: PramipexoleBoehringer IngelheimNULLCompleted30 YearsN/AAll511Phase 3United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina
1305NCT00562198
(ClinicalTrials.gov)
January 200819/11/2007PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride BindingEffects of Single Doses of Stalevo 200 and Levodopa/Carbidopa 200/50mg on Striatal 11C-Raclopride Binding Potential in Parkinson's Disease Patients With Wearing-Off Symptoms;an Open, Randomised, Active-Controlled,Two-Period Crossover Study.Parkinson´s DiseaseDrug: entacapone and carbidopa;Drug: Sinemet 200mg/50mgOrion Corporation, Orion PharmaNULLTerminated45 Years80 YearsBoth16Phase 2Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1306EUCTR2006-003732-30-IT
(EUCTR)
31/12/200713/02/2008Transdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep ITransdermal Use of Lisuride in Early ParkinsonŽs Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - Tulep I Diagnosys of Early-stage idiopathic Parkinson's Disease for longest 1 year
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: lisuride TTS
INN or Proposed INN: Lisuride
Trade Name: mirapexin
INN or Proposed INN: Pramipexole
NEUROBIOTEC GMBHNULLNot RecruitingFemale: yes
Male: yes
350Germany;Italy;Poland
1307EUCTR2007-004400-12-ES
(EUCTR)
27/12/200703/01/2008ENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and ApathyENSAYO RANDOMIZADO A DOBLE CIEGO Y CONTROLADO CON PLACEBO DE RASAGILINA EN PACIENTES CON ENFERMEDAD DE PARKINSON Y SINTOMAS DE APATIA - Rasagiline and Apathy Apatía en la Enfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Azilect
INN or Proposed INN: RASAGILINE
Institut de Recerca de l'Hospital de la santa Creu i Sant PauNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
1308EUCTR2007-004654-81-GB
(EUCTR)
20/12/200716/10/2007A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patientsA phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients Sialorrhoea associated with Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10059812;Term: Sialorrhoea
Trade Name: Catapres ampoules
INN or Proposed INN: Clonidine hydrochloride
Trade Name: Ditropan elixir
INN or Proposed INN: Oxybutynin hydrochloride
Summit (Cambridge) Ltd.NULLNot RecruitingFemale: yes
Male: yes
Phase 2aUnited Kingdom
1309EUCTR2007-000801-30-HU
(EUCTR)
20/12/200715/11/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
1310EUCTR2006-006907-35-IT
(EUCTR)
19/12/200720/04/2007A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVERA multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER Patient with Idiopathic Parkinson Diesease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: rotigotine
INN or Proposed INN: rotigotine
SCHWARZ PHARMANULLNot RecruitingFemale: yes
Male: yes
270Phase 3bHungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1311EUCTR2004-000185-12-GB
(EUCTR)
13/12/200711/02/2005A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot Recruiting Female: yes
Male: yes
740Phase 3Finland;Austria;Italy;United Kingdom;Sweden
1312EUCTR2007-002963-28-FI
(EUCTR)
12/12/200718/10/2007A trial to determine the efficacy and safety of a low (50mg/day) and high (100mg/day) dose of safinamide, as add-on therapy, in patients with early Parkinson's Disease treated with a single dopamine agonist.A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals SpANULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;United States;Finland;Spain;Chile;Colombia;Italy;India;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Bulgaria;South Africa;Germany
1313EUCTR2007-002964-90-NL
(EUCTR)
11/12/200711/12/2007A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1121Phase 3Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
1314EUCTR2007-002964-90-SK
(EUCTR)
06/12/200716/04/2008A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
540Phase 3France;Czech Republic;Estonia;Hungary;Slovakia;Finland;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom
1315EUCTR2007-002963-28-SK
(EUCTR)
06/12/200716/04/2008A phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonistA phase III, double-blind, placebo-controlled randomised trial to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in subjects with early idiopathic Parkinson’s Disease treated with a stable dose of a single dopamine agonist. - Safinamide in early IPD, as add-on to dopamine agonist Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
839Phase 3Portugal;Czech Republic;Slovakia;Finland;Poland;Spain;Bulgaria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1316EUCTR2007-002964-90-FI
(EUCTR)
04/12/200718/10/2007A phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopaA phase III, double-blind, placebo-controlled, randomised trial to determine the efficacy and safety of a dose range of 50 to 100 mg/day of safinamide, as add-on therapy, in subjects with idiopathic Parkinson’s Disease with motor fluctuations, treated with a stable dose of levodopa and who may be receivingconcomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine. - Safinamide in IPD with motor fluctuations, as add-on to levodopa Ideopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1121Phase 3Hungary;Finland;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;Estonia;France;Spain;Austria
1317NCT00577460
(ClinicalTrials.gov)
December 200719/12/2007Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PDLong-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)Parkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll391Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
1318NCT00584025
(ClinicalTrials.gov)
December 200721/12/2007Keppra IV for the Treatment of Motor Fluctuations in Parkinson's DiseaseParkinson's DiseaseDrug: levetiracetam;Drug: PlaceboUniversity of South FloridaNULLWithdrawn30 Years80 YearsAll0Phase 4United States
1319EUCTR2007-004985-41-SE
(EUCTR)
29/11/200710/10/2007Different dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia studyDifferent dyskinesias in Parkinson's disease and their relation to levodopa pharmacokinetics - The dyskinesia study Parkinson's disease, G20.9. Different dyskinesias related to advanced Parkinson's disease will be investigated.Trade Name: Duodopa
INN or Proposed INN: levodopa
INN or Proposed INN: carbidopa
Department of Neuroscience, neurologyNULLNot RecruitingFemale: yes
Male: yes
Sweden
1320EUCTR2007-000801-30-ES
(EUCTR)
29/11/200712/09/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motorasA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras Parkinson's DiseaseEnfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1321NCT00537017
(ClinicalTrials.gov)
November 23, 200727/9/2007Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain DiseasesDrug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll140Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States
1322EUCTR2006-005186-18-FI
(EUCTR)
16/11/200704/10/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
1323EUCTR2007-002906-23-GB
(EUCTR)
14/11/200715/08/2007A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
280United Kingdom;Bulgaria;France
1324EUCTR2007-002496-14-FI
(EUCTR)
05/11/200714/09/2007Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study.Effects of single doses of Stalevo 200 and levodopa/carbidopa 200/50 mg on striatal 11C-raclopride binding potential in Parkinson’s disease patients with wearing-off symptoms. An open, randomised, active-controlled, two-period crossover study. Parkinson’s disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Stalevo®
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet®
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Product Name: 11C-Raclopride
Other descriptive name: 11C-Raclopride
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
Finland
1325ChiCTR-TRC-07000027
2007-11-012007-11-09A randomized controlled clinical study of Pramipexole for Parkinson's diseaseA randomized controlled clinical study of Pramipexole for Parkinson's disease Primary Parkinson's diseaseGroup 1:Artane oral 1-2mg, tid,+ Mirapexin, 0.25 mg/d at beginning, and add to 1.0 mg/d at the end of the second week; the dose will be added from the second weekend to the eighth week to 4. 5 mg/d(1.5 mg, tid); maintain the dose during 12 weeks and reduce the dose during 1-4weeks;Group 3:Artane oral 1-2mg, tid + Madopar, 62.5~500 mg, 2~4 times a day depends on the serious of disease + Mirapexin, the dose is same as group 1;Group 2:Artane oral 1-2mg, tid+ Benserazide-Levodopa (Madopar), oral 62.5~500 mg, 2~4 times a day depends on the serious of the disease;First Affiliated Hospital of Xinjiang Medical UniversityNULLCompleted3080BothGroup 1:45;Group 3:45;Group 2:45;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1326NCT00560508
(ClinicalTrials.gov)
November 200716/11/2007A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment PeriodA Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ERParkinson DiseaseDrug: Pramipexole Immediate Release;Drug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted1 YearN/AAll112Phase 2;Phase 3Japan
1327NCT00584090
(ClinicalTrials.gov)
November 200721/12/2007Solifenacin Succinate (VESIcare) for the Treatment of Urinary Incontinence in Parkinson's DiseaseUrinary Incontinence;Parkinson's DiseaseDrug: Solifenacin Succinate (VESIcare);Drug: PlaceboUniversity of South FloridaNULLWithdrawn30 Years80 YearsBoth0Phase 4United States
1328NCT00610103
(ClinicalTrials.gov)
November 200722/1/2008Phase 2 Clinical Study of KW-6500 in Parkinson's Disease Patients With Motor Response Complication on Levodopa TherapyA Phase 2 Clinical Study of KW-6500 (Apomorphine Hydrochloride) in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: apomorphine hydrochlorideKyowa Kirin Co., Ltd.NULLCompleted20 YearsN/AAll16Phase 2Japan
1329NCT00605683
(ClinicalTrials.gov)
November 200719/12/2007MOTION, Safinamide in Early IPD, as add-on to Dopamine AgonistA Phase III, Double-blind, Placebo-controlled Randomised Trial to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Subjects With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine AgonistIdiopathic Parkinson's DiseaseDrug: Safinamide (as add-on therapy)NewronNULLCompleted30 Years80 YearsBoth679Phase 3United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Finland;Germany;India;Italy;Mexico;Peru;Poland;Portugal;Slovakia;South Africa;Spain;Israel
1330NCT00632762
(ClinicalTrials.gov)
November 200720/2/2008Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.Parkinson's DiseaseDrug: mantadixUniversity Hospital, ToulouseNULLCompleted30 Years80 YearsBoth80Phase 4France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1331NCT00558337
(ClinicalTrials.gov)
November 200712/11/2007Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's DiseaseAn Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease PatientsParkinson's DiseaseDrug: levodopa-carbidopaOsmotica Pharmaceutical Corp.NULLCompleted30 Years80 YearsBoth78Phase 2Argentina
1332EUCTR2007-004234-16-NL
(EUCTR)
29/10/200717/10/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
1333EUCTR2007-002906-23-FR
(EUCTR)
25/10/200721/08/2007A Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseA Multi-Center, Placebo-Controlled, Double-Blind Trial To Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
280United Kingdom;Bulgaria;France
1334EUCTR2007-001717-42-FR
(EUCTR)
25/10/200711/09/2007A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/AA Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and DyskinesiasProduct Name: SCH 420814
Product Code: N/A
Schering Plough Research InstituteNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2France;Spain
1335EUCTR2007-003353-90-NL
(EUCTR)
23/10/200707/08/2007A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Pramipexole
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Germany;Netherlands;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1336EUCTR2007-000801-30-FR
(EUCTR)
22/10/200723/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
726Hungary;Czech Republic;Estonia;France;Spain;Italy;Latvia;Poland;Lithuania
1337EUCTR2007-003353-90-FR
(EUCTR)
17/10/200727/08/2007A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Pramipexole
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
BOEHRINGER INGELHEIMNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Germany;Netherlands;France
1338EUCTR2006-006907-35-GB
(EUCTR)
09/10/200726/04/2007Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVERLong-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8mg/24h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbH, UCB GroupNULLNot RecruitingFemale: yes
Male: yes
270Phase 3Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom
1339EUCTR2005-005791-32-SE
(EUCTR)
04/10/200730/07/2007Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.
MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)
Product Name: HF0220
Product Code: HF0220
Other descriptive name: 7-beta-hydroxyepiandrosterone
Hunter-Fleming LtdNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom;Sweden
1340EUCTR2007-002900-16-DE
(EUCTR)
01/10/200721/08/2007A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopaA multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration study in patients with Parkinson’s disease to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias, and the safety and tolerability of AFQ056 in combination with L-dopa The main objective of this study is to assess the efficacy of AFQ056 in reducing L-dopa induced dyskinesias.Product Code: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
34Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1341NCT00558025
(ClinicalTrials.gov)
October 200712/11/2007Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson DiseaseA Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IRParkinson DiseaseDrug: Pramipexole Extended Release;Drug: Pramipexole Immediate ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll156Phase 3France;Germany;Netherlands
1342NCT00642928
(ClinicalTrials.gov)
October 200721/3/2008Dose Range Finding Study of BF2.649 Versus Placebo to Treat Excessive Daytime Sleepiness in Parkinson's Disease PatientsRandomized, Dose-finding Study of BF 2.649 5, 10 20 and 40 mg/d in Comparison to Placebo in Excessive Daytime Sleepiness in Parkinson's Disease Patients (PD)Excessive Daytime Sleepiness;Parkinson's DiseaseDrug: Placebo;Drug: BF 2.649 5 mg;Drug: BF 2.649 10 mg;Drug: BF 2.649 20 mg;Drug: BF 2.649 40 mgBioprojetNULLCompleted18 YearsN/ABoth108Phase 2France
1343NCT00566462
(ClinicalTrials.gov)
October 200729/11/2007Assessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTAssessment of Perampanel (E2007) on Synaptic Dopamine in Mild-moderate PD Patients: A Pilot Study With [^123I]-IBZM SPECTParkinson's DiseaseDrug: perampanel;Drug: placeboEisai Inc.NULLTerminated30 YearsN/AAll1Phase 2United States
1344NCT00582673
(ClinicalTrials.gov)
October 200721/12/2007Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients, and Safety in Combination With L-dopaA Multi-centre, Randomized, Double-blind, Placebo Controlled, Parallel-group, Multiple Oral Dose Titration Study in Patients With Parkinson's Disease to Assess the Efficacy of AFQ056 in Reducing L-dopa Induced Dyskinesias, and the Safety and Tolerability of AFQ056 in Combination With L-dopaParkinson's DiseaseDrug: AFQ056;Drug: PlaceboNovartisNULLCompleted30 Years85 YearsBoth31Phase 2Germany
1345NCT00547911
(ClinicalTrials.gov)
October 200719/10/2007Augmenting Effects of L-DOPS With Carbidopa and EntacaponeL-Dihydroxyphenylserine (L-DOPS) for Norepinephrine Deficiency: Interactions With Carbidopa and EntacaponeParkinson Disease;Multiple System Atrophy;Autonomic Nervous System DiseasesDrug: Droxidopa;Drug: Carbidopa;Drug: EntacaponeNational Institute of Neurological Disorders and Stroke (NINDS)NULLTerminated18 YearsN/AAll14Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1346NCT01520727
(ClinicalTrials.gov)
October 200718/1/2012A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male SubjectsA Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsMale64Phase 1France
1347EUCTR2006-002937-20-HU
(EUCTR)
20/09/200717/05/2007A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1348EUCTR2007-002899-34-GB
(EUCTR)
18/09/200726/06/2007Pilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's DiseasePilot Controlled Clinical Trial of Salvia Officinalis (Sage) for cognitive impairments in Parkinson's Disease Cognitive impairment in Parkinson's DiseaseProduct Name: Sage leafNewcastle Upon tyne Hospitals NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
1349EUCTR2007-002874-75-IT
(EUCTR)
10/09/200714/01/2008Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 Psycosis associated to Parkinson's Disease
MedDRA version: 9.1;Level: HLT;Classification code 10027361;Term: Mental disorders due to a general medical condition NEC
Product Name: MelperonOVATION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
1350EUCTR2007-000801-30-LT
(EUCTR)
07/09/200705/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1351EUCTR2007-003353-90-DE
(EUCTR)
05/09/200708/08/2007A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Pramipexole
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
132Germany;Netherlands;France
1352NCT00524914
(ClinicalTrials.gov)
September 20074/9/2007Apomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging StudyApomorphine Effect on Nociceptive Perception in Parkinson's: a Clinical and Imaging Study.Parkinson's DiseaseDrug: apomorphine;Drug: placeboUniversity Hospital, ToulouseNULLCompleted30 Years70 YearsBoth16N/AFrance
1353NCT00594464
(ClinicalTrials.gov)
September 200721/12/2007A Trial of Neupro® (Rotigotine Transdermal Patch) in Patients With Parkinson's Disease Undergoing SurgeryAn Explorative, Multicenter, Open-label Pilot Trial With Neupro® (Rotigotine Transdermal Patch) Once Daily Treatment Administered Perioperatively in Patients With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 Years80 YearsAll14Phase 4Germany
1354NCT00537485
(ClinicalTrials.gov)
September 200727/9/2007A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease PatientsA Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopaEarly Parkinson's DiseaseDrug: SPM 962;Drug: placeboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll180Phase 2;Phase 3Japan
1355EUCTR2007-000801-30-PL
(EUCTR)
29/08/200717/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1356EUCTR2007-003512-57-FR
(EUCTR)
24/08/200723/07/2007Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD)Randomized, dose-finding study of BF 2.649 5, 10, 20 and 40 mg/d in comparison to placebo in Excessive Daytime Sleepiness in Parkinson’s Disease patients (PD) Excessive daytime sleepiness associated to Parkinson disease
MedDRA version: 9.1;Level: LLT;Classification code 10041014;Term: Sleepiness
MedDRA version: 9.1;Classification code 10061536;Term: Parkinson's disease
Product Name: BF 2.649
Product Code: BF 2.649
Product Name: BF 2.649
Product Code: BF 2.649
Product Name: BF 2.649
Product Code: BF 2.649
Product Name: BF 2.649
Product Code: BF 2.649
BioprojetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130France
1357EUCTR2007-000801-30-EE
(EUCTR)
22/08/200717/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
1358EUCTR2006-000859-18-DE
(EUCTR)
13/08/200705/04/2007An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania
1359EUCTR2007-000074-23-HU
(EUCTR)
10/08/200701/06/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
1360EUCTR2007-000801-30-CZ
(EUCTR)
01/08/200715/06/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1361NCT00442780
(ClinicalTrials.gov)
August 20071/3/2007Dose-Finding Safety Study of BIIB014 in Early-Stage Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Doses of BIIB014 Administered Orally in Subjects With Early Parkinson's DiseaseParkinson's DiseaseDrug: BIIB014;Drug: PlaceboBiogen IdecNULLCompleted30 YearsN/ABoth36Phase 2Israel;Poland;Serbia;Former Serbia and Montenegro
1362NCT00407095
(ClinicalTrials.gov)
August 200730/11/2006An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.Advanced Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth140Phase 3United States;Albania;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine
1363NCT01286935
(ClinicalTrials.gov)
August 200723/8/201018-month Study of Long-term Efficacy & Safety of Safinamide as add-on Therapy in Patients With Mid-late Stage PDA Phase III, Double-blind, Placebo-controlled, 18-mon Ext Study Long-term Efficacy & Safety of 50 & 100mg/Day Doses of Safinamide, as add-on Therapy, in Idiopathic PD Pts With Motor Fluctuations, Treated With Levodopa, Who May be Receiving DA, and/or AnticholinergicParkinson's DiseaseDrug: Safinamide;Drug: PlaceboNewronNULLCompleted30 Years80 YearsBoth544Phase 3NULL
1364NCT00335374
(ClinicalTrials.gov)
August 20078/6/2006An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD PatientsAn Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD PatientsEarly Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth202Phase 3United States;Australia;Czech Republic;Estonia;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Taiwan;Thailand;France;Spain;United Kingdom
1365EUCTR2007-000801-30-LV
(EUCTR)
27/07/200705/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1366EUCTR2006-006752-35-GB
(EUCTR)
23/07/200713/01/2009 RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINE PHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Schwarz Biosciences GmbH, UCB GroupNULLNot Recruiting Female: yes
Male: yes
400Phase 3Hungary;Finland;Spain;Austria;Germany;Italy;United Kingdom
1367EUCTR2007-000801-30-IT
(EUCTR)
17/07/200713/11/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - NDA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND Parkinson's Disease Subjects with Motor Fluctuations
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: E2007EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
726Phase 3France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy
1368EUCTR2006-005318-11-FR
(EUCTR)
06/07/200710/05/2007Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons.Effet de l'apomorphine sur la perception douloureuse chez le patient parkinsonien : étude clinique et en tomographie par émission de positons. maladie de Parkinson
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: APOKINONCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
1369NCT00515437
(ClinicalTrials.gov)
July 200710/8/2007A Multi-Center Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease PatientsA Multi-Center, Randomized, Double-blind, Placebo-Controlled,Sequential Dose Escalation, Safety, Tolerability, and Preliminary Efficacy Study of MYOBLOC for the Treatment of Sialorrhea in Parkinson's Disease PatientsDroolingBiological: Botulinum Toxin Type B (Myobloc);Biological: Matched placebo to MyoblocSolstice NeurosciencesNULLCompleted18 Years85 YearsAll54Phase 2United States
1370NCT00505622
(ClinicalTrials.gov)
July 20079/7/2007Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: PerampanelEisai LimitedNULLTerminated30 YearsN/AAll328Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1371NCT00522379
(ClinicalTrials.gov)
July 200728/8/2007Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal PatchA Multicenter, Randomized, Double-blind, Placebo-controlled, 5-arm, Parallel-group Trial to Assess Rotigotine Transdermal System Dose Response in Subjects With Advanced-stage Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB PharmaNULLCompleted30 YearsN/AAll514Phase 3United States;Chile;India;Mexico;Peru
1372NCT00550238
(ClinicalTrials.gov)
July 200726/10/2007A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll459Phase 3United States;Austria;Belgium;Canada;France;India;Italy;Poland;Portugal;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom
1373NCT00519532
(ClinicalTrials.gov)
July 200721/8/2007Long-term Extension of RECOVER- Long-term Effect of the 24h Transdermal Delivery of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseA Multicenter, Multinational, Phase 3b, Open-label Extension Trial to Evaluate the Long-term Effect of the 24-hour Transdermal Delivery of Rotigotine on Motor Function, Sleep Quality, and Nocturnal and Non-motor Symptoms in Subjects With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLTerminated18 YearsN/AAll84Phase 3United States;Australia;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom;Austria
1374NCT00593606
(ClinicalTrials.gov)
July 200721/12/2007Safety and Tolerability Trial of Switching From Ropinirole to RotigotineA Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 YearsN/AAll124Phase 3NULL
1375EUCTR2006-006752-35-HU
(EUCTR)
22/06/200712/04/2007RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RecoverRECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24 h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24 h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1376EUCTR2007-000073-39-CZ
(EUCTR)
18/06/200718/04/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
1377EUCTR2007-000074-23-CZ
(EUCTR)
18/06/200731/05/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Spain;Austria;Italy;United Kingdom;Sweden
1378EUCTR2006-000678-57-CZ
(EUCTR)
18/06/200702/08/2006A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1379EUCTR2007-000073-39-HU
(EUCTR)
14/06/200731/05/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Finland;Hungary;Czech Republic;Austria
1380EUCTR2007-000074-23-SK
(EUCTR)
14/06/200709/04/2008A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Slovakia;Spain;Austria;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1381EUCTR2007-000073-39-SK
(EUCTR)
14/06/200709/04/2008A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Finland;Austria;Germany
1382EUCTR2006-005438-19-DE
(EUCTR)
12/06/200728/03/2007An explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOSAn explorative, multicenter, open-label pilot trial with Neupro® (Rotigotine transdermal patch) once daily treatment administered perioperatively in Patients with idiopathic Parkinson´s disease. - NEUPOS idiopathic Parkinson´s disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2 mg/24 h transdermal patch
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4 mg/24 h transdermal patch
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6 mg/24 h transdermal patch
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
INN or Proposed INN: Rotigotine
SCHWARZ PHARMA Deutschland GmbHNULLNot RecruitingFemale: yes
Male: yes
30Germany
1383EUCTR2006-005861-21-IT
(EUCTR)
11/06/200705/01/2007A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC.A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE LONG-TERM EFFICACY AND SAFETY OF A LOW (50 MG/DAY) AND HIGH (100 MG/DAY) DOSE OF SAFINAMIDE, AS ADD-ON THERAPY, IN PATIENTS WITH IDIOPATHIC PARKINSON`S DISEASE WITH MOTOR FLUCTUATIONS, TREATED WITH A STABLE DOSE OF LEVODOPA AND WHO MAY BE RECEIVING CONCOMITANT TREATMENT WITH STABLE DOSES OF A DOPAMINE AGONIST, AND/OR AN ANTICHOLINERGIC. Patients with idiopathic Parkinson's disease with motor fluctuations
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Monoamine oxidase B inhibitors
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Monoamine oxidase B inhibitors
NEWRON PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Italy
1384EUCTR2006-006684-22-FR
(EUCTR)
08/06/200727/03/2007Evaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSKEvaluation des effets à long terme de l’amantadine chez le parkinsonien souffrant de dyskinésies induites par la lévodopa : Etude randomisée en double-insu versus placebo de l’arrêt d’une prescription chronique. - AMANDYSK maladie de parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
MedDRA version: 9.1;Classification code 10013916;Term: Dyskinesia
Trade Name: MANTADIXCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
1385EUCTR2006-000858-45-SE
(EUCTR)
05/06/200704/04/2007An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Finland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1386NCT00462254
(ClinicalTrials.gov)
June 200716/4/2007Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's DiseaseRamelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's DiseaseParkinson's DiseaseDrug: ROZEREM;Drug: RamelteonSouthern California Institute for Research and EducationNULLTerminated45 Years85 YearsBoth4Phase 4United States
1387NCT00571285
(ClinicalTrials.gov)
June 20077/12/2007Clinical Effects of Vitamin D Repletion in Patients With Parkinson's DiseaseClinical Effects of Vitamin D Repletion in Patients With Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Vitamin D3;Dietary Supplement: Vitamin D3 - high dose;Dietary Supplement: PlaceboEmory UniversityNULLTerminated18 Years89 YearsAll31Phase 4United States
1388NCT00477672
(ClinicalTrials.gov)
June 200722/5/2007A Study of the Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisA Multi-Center, Placebo-Controlled, Double-Blind Trial to Examine the Safety and Efficacy of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103);Drug: PlaceboACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll298Phase 3United States;Bulgaria;France;India;Russian Federation;Ukraine;United Kingdom
1389NCT00460954
(ClinicalTrials.gov)
June 200716/4/2007A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy SubjectsAn Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy SubjectsParkinson's DiseaseDrug: Sinemet® controlled release (Carbidopa/levodopa)Bristol-Myers SquibbNULLCompleted50 Years75 YearsBoth20N/ACanada
1390NCT00485069
(ClinicalTrials.gov)
June 200711/6/2007REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 StudyPost-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -Parkinson Disease;Parkinson's DiseaseDrug: ROP;Drug: ROP+L-DopaGlaxoSmithKlineNULLCompleted20 YearsN/AAll123Phase 4Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1391NCT00696215
(ClinicalTrials.gov)
June 200710/6/2008The Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's DiseaseThe Effects of Rasagiline on Cognitive Deficits Associated With Parkinson's Disease: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Over 3 MonthsParkinson's DiseaseDrug: placebo;Drug: rasagilineIstanbul UniversityNULLRecruitingN/AN/ABoth40Phase 4Turkey
1392EUCTR2007-000074-23-AT
(EUCTR)
30/05/200705/06/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
1393EUCTR2007-000073-39-AT
(EUCTR)
30/05/200705/06/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
1394EUCTR2007-000074-23-ES
(EUCTR)
29/05/200702/03/2010A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+.A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).Estudio aleatorizado, doble ciego, doble simulación, controlado con placebo de tres grupos paralelos que compara la eficacia, la seguridad y la tolerabilidad de pramipexol ER frente a placebo y frente a pramipexol IR administrados por vía oral durante una fase de mantenimiento de 26 semanas de duración en pacientes con enfermedad de Parkinson (EP) avanzada tratados con L-Dopa+. Pacientes varones o mujeres, diagnosticados de enfermedad de Parkinson idiopática, al menos dos años antes, con 30 años o más de edad en el momento del diagnóstico, con un estadío entre 2 y 4 en la escala modificada de Hoehn y Yahr en el periodo on.Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
1395EUCTR2007-000073-39-DE
(EUCTR)
29/05/200726/02/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Czech Republic;Finland;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1396EUCTR2006-006752-35-ES
(EUCTR)
27/05/200727/03/2007RECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - RecoverRECOVER: EVALUACIÓN ALEATORIZADA DE LA COBERTURA 24 HORAS: EFICACIA DE ROTIGOTINA. ESTUDIO DE FASE 3B, MULTICÉNTRICO, MULTINACIONAL, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE 2 BRAZOS PARA EVALUAR EL EFECTO DE LA ADMINISTRACIÓN TRANSDÉRMICA 24 HORAS DE ROTIGOTINA SOBRE EL CONTROL DE LA FUNCIÓN MOTORA A PRIMERA HORA DE LA MAÑANA, LA CALIDAD DEL SUEÑO, LOS SÍNTOMAS NOCTURNOS Y LOS SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Recover Enfermedad de Parkinson(Parkinson's disease)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24 h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24 h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
1397EUCTR2006-006907-35-ES
(EUCTR)
27/05/200727/03/2007EXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVEREXTENSIÓN A LARGO PLAZO DE RECOVER. ESTUDIO DE EXTENSIÓN MULTICÉNTRICO, MULTINACIONAL, DE FASE 3B, ABIERTO, PARA EVALUAR EL EFECTO A LARGO PLAZO DE LA ADMINISTRACIÓN TRANSDÉRMICA DURANTE 24 HORAS DE ROTIGOTINA SOBRE LA FUNCIÓN MOTORA, LA CALIDAD DEL SUEÑO Y LOS SÍNTOMAS NOCTURNOS Y SÍNTOMAS NO MOTORES EN SUJETOS CON ENFERMEDAD DE PARKINSON IDIOPÁTICA.(Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE) - Long-term extension of RECOVER Enfermedad de Parkinson(Parkinson's disease)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8mg/24h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3BHungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
1398EUCTR2006-006907-35-HU
(EUCTR)
17/05/200712/04/2007Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVERLong-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8mg/24h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3BFinland;Hungary;United Kingdom;Germany;Spain;Italy;Austria
1399EUCTR2007-000074-23-IT
(EUCTR)
17/05/200706/04/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - NDA double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa treated patients with advanced Parkinson s disease PD . - ND Patients with advanced idiopathic Parkinson s disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: pramipexole ER
Product Code: SND 919 CL2Y
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
Trade Name: Sifrol
Trade Name: Sifrol
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
645Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
1400EUCTR2007-000074-23-GB
(EUCTR)
11/05/200729/03/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1401EUCTR2006-006907-35-FI
(EUCTR)
09/05/200721/03/2007Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVERLong-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8mg/24h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3BHungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
1402EUCTR2006-006752-35-FI
(EUCTR)
09/05/200721/03/2007RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RecoverRECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24 h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24 h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
1403EUCTR2007-000074-23-SE
(EUCTR)
02/05/200702/04/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD).A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in L-Dopa+ treated patients with advanced Parkinson’s disease (PD). Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
INN or Proposed INN: Pramipexole
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
516Phase 1Hungary;United Kingdom;Spain;Italy;Austria;Sweden
1404NCT00505843
(ClinicalTrials.gov)
May 200724/7/2007A Study of MK0657 in Parkinson's Disease Patients (0657-006)A Randomized, Double-Blind, Placebo-Controlled, 2-Period Crossover Study to Evaluate Effectiveness of Single-Dose MK0657 in Combination With Levodopa on Motor Symptoms and Dyskinesias in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: MK0657;Drug: Comparator: Placebo (unspecified);Drug: Comparator: levodopa;Drug: Comparator: carbidopaMerck Sharp & Dohme Corp.NULLCompleted40 Years80 YearsBoth18Phase 1United States
1405NCT00479401
(ClinicalTrials.gov)
May 200725/5/2007Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD PatientsA Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).Early Parkinson Disease (Early PD)Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: PlaceboBoehringer IngelheimNULLCompleted30 YearsN/AAll539Phase 3United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1406NCT00474058
(ClinicalTrials.gov)
May 200714/5/2007Randomized Evaluation of the 24-Hour Coverage: Efficacy of RotigotinePhase 3B, Multicenter, Multinational, Double-Blind, Placebo Controlled, 2-Arm Trial to Evaluate the Effect of the 24-Hour Transdermal Delivery of Rotigotine on the Control of Early Morning Motor Function, Sleep Quality, Nocturnal Symptoms, and Non-Motor Symptoms in Subjects With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB PharmaNULLCompleted18 YearsN/AAll287Phase 3United States;Australia;Austria;Finland;Germany;Hungary;Italy;New Zealand;Poland;South Africa;Spain;United Kingdom
1407EUCTR2006-002937-20-ES
(EUCTR)
27/04/200726/04/2007Estudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones MotorasEstudio Multicéntrico, Randomizado, Doble ciego, Controlado con Placebo y Entacapona, de Grupos Paralelos, para evaluar la eficacia, Seguridad y Tolerabilidad de E2007 en Pacientes con Enfermedad de Parkinson Tratados con Levodopa, y Fluctuaciones Motoras Enfermedad de Parkinson
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1408EUCTR2006-002339-26-PT
(EUCTR)
27/04/200707/03/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1409EUCTR2006-000577-29-DE
(EUCTR)
27/04/200712/10/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Trade Name: Sinemet®25-100
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories)NULLNot RecruitingFemale: yes
Male: yes
31United States;Germany
1410EUCTR2007-000073-39-FI
(EUCTR)
25/04/200706/03/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1411EUCTR2007-000307-15-IT
(EUCTR)
24/04/200723/08/2007Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease.Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. Psicosi associata al morbo di Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Melperon
INN or Proposed INN: melperon
OVATION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
1412EUCTR2006-002339-26-ES
(EUCTR)
19/04/200730/01/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1413EUCTR2006-006907-35-AT
(EUCTR)
17/04/200721/05/2007Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVERLong-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8mg/24h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3BHungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
1414EUCTR2006-006752-35-AT
(EUCTR)
17/04/200721/05/2007RECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - RecoverRECOVER: RANDOMIZED EVALUATION OF THE 24-HOUR COVERAGE: EFFICACY OF ROTIGOTINEPHASE 3B, MULTICENTER, MULTINATIONAL, DOUBLE-BLIND, PLACEBO CONTROLLED, 2-ARM TRIAL TO EVALUATE THE EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON THE CONTROL OF EARLY MORNING MOTOR FUNCTION, SLEEP QUALITY, NOCTURNAL SYMPTOMS, AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Recover Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24 h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24 h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24 h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
400Phase 3BHungary;Finland;Spain;Austria;Germany;United Kingdom;Italy
1415EUCTR2006-002339-26-DE
(EUCTR)
10/04/200722/12/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1416NCT00434304
(ClinicalTrials.gov)
April 9, 20079/2/2007Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -Parkinson DiseaseDrug: Ropinirole prolonged release/extended release(PR/XR)GlaxoSmithKlineNULLCompleted20 YearsN/AAll62Phase 2Japan
1417NCT00466167
(ClinicalTrials.gov)
April 200725/4/2007Pivotal Study in Advanced Parkinsons Disease PatientsA Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).Parkinson DiseaseDrug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll517Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
1418NCT00623363
(ClinicalTrials.gov)
April 20072/1/2008Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's DiseaseParkinson's DiseaseDrug: piclozotan;Drug: 0.9% sodium chloride (normal saline)Asubio Pharmaceuticals, Inc.NULLCompleted40 Years85 YearsBoth27Phase 2United States;Guatemala;Romania
1419NCT00460148
(ClinicalTrials.gov)
April 200711/4/2007Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of RopiniroleAn Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets.Parkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted30 Years85 YearsBoth28Phase 2Germany;South Africa
1420NCT00438607
(ClinicalTrials.gov)
April 200720/2/2007Dose-Finding Safety Study of BIIB014 in Combination With Levodopa in Moderate to Late Stage Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects With Moderate to Late Stage Parkinson's Disease Who Are Also Receiving Treatment With LevodopaParkinson's DiseaseDrug: BIIB014;Drug: PlaceboBiogen IdecNULLCompleted30 YearsN/ABoth83Phase 2India;Israel;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1421EUCTR2006-006209-94-DE
(EUCTR)
15/03/200726/01/2007An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Requip-Modutab
Product Name: Requip-Modutab
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
Trade Name: Requip-Modutab
Product Name: Requip-Modutab
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
Trade Name: Requip-Modutab
Product Name: Requip-Modutab
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
Product Name: Ropinirole
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
36Germany
1422EUCTR2006-002937-20-FR
(EUCTR)
12/03/200712/02/2007A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
INN or Proposed INN: entacapone
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
702Hungary;Czech Republic;Estonia;France;Spain;Italy;Latvia;Lithuania
1423NCT00455507
(ClinicalTrials.gov)
March 20072/4/2007A Phase 2b Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaPlacebo-controlled, Double-blind, Parallel Group, Fixed Dose Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 2 Study)Parkinson's DiseaseDrug: Istradefylline;Drug: PlaceboKyowa Hakko Kirin Company, LimitedNULLCompleted20 YearsN/ABoth363Phase 2Japan
1424NCT00406588
(ClinicalTrials.gov)
March 200730/11/2006SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor FluctuationsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of SLV308 as Adjunct Therapy to Levodopa in Patients With Parkinson's Disease Experiencing Motor Fluctuations.Advanced Stage Parkinson's DiseaseDrug: Pardoprunox;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth295Phase 3United States;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine
1425NCT00437125
(ClinicalTrials.gov)
March 200716/2/2007Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's DiseaseAn Open Label Pilot Study on the Tolerability of Duloxetine in the Treatment of Depressed Patients With Parkinson's DiseaseMajor Depressive Disorder;Idiopathic Parkinson DiseaseDrug: Duloxetine hydrochlorideEli Lilly and CompanyNULLCompleted30 Years75 YearsAll151Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1426NCT00451633
(ClinicalTrials.gov)
March 200721/3/2007The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor FluctuationsA Randomized, Double Blind, Placebo-Controlled Study To Investigate The Effect Of E2007 On Pharmacodynamic Responses To Levodopa Among Patients With Parkinson's Disease Who Experience Dyskinesia And Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLWithdrawn30 Years80 YearsBoth0Phase 2Germany;Italy
1427EUCTR2005-002038-36-GR
(EUCTR)
27/02/200709/10/2006A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy BodiesA randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies Patients with Parkinson’s disease dementia or dementia with Lewy Bodies
MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
H. Lundbeck A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Germany;United Kingdom;France;Spain;Italy;Greece;Austria
1428EUCTR2006-002408-32-ES
(EUCTR)
27/02/200707/02/2007Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa.Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. Fluctuaciones motoras, cognitivas y del humor en la enfermedad de Parkinson.
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo 150
Product Name: Levodopa-carbidopa-entacapone
Trade Name: Sinemet
Product Name: Levodopa/Carbidopa
Institut de Recerca del Hospital de la Santa Creu i Sant PauNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Spain
1429EUCTR2006-005714-12-IT
(EUCTR)
27/02/200703/08/2007A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213A randomized, double blind, placebo-controlled study to investigate the effect of E2007 on pharmacodynamic responses to levodopa among patients with Parkinson's disease who experience dyskinesia and motor fluctuations. - E2007-E044-213 Patients with idiopathic Parkinson's disease who respond to levodopa treatment but who experience peak-effect levodopa-induced dyskinesia and end-of-dose 'wearing-off' motor fluctuations
MedDRA version: 6.1;Level: HLT;Classification code 10034005
Product Name: E2007
Product Code: E2007
INN or Proposed INN: OTHER NERVOUS SYSTEM DRUGS
Trade Name: SINEMET
INN or Proposed INN: levodopa-carbidopa
EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
24Italy
1430EUCTR2006-005183-91-LT
(EUCTR)
14/02/200720/12/2006An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian studyAn open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study Advanced stage Parkinson's disease with motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
220Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1431EUCTR2006-005182-20-LT
(EUCTR)
13/02/200720/12/2006A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan studyA multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study Advanced stage Parkinson's disease with motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
280Latvia;Lithuania
1432EUCTR2006-005183-91-LV
(EUCTR)
02/02/200711/01/2007An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan studyAn open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study Advanced stage Parkinson's disease with motor fluctuations.Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Latvia;Lithuania
1433EUCTR2006-005182-20-LV
(EUCTR)
02/02/200728/12/2006A multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan studyA multicenter, randomized, double-blind, placebo-controlled, parallel group study of SLV308 as adjunct therapy to levodopa in patients with Parkinson’s disease experiencing motor fluctuations. - The Mondriaan study Advanced stage Parkinson's disease with motor fluctuations.Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
280Latvia;Lithuania
1434NCT00427011
(ClinicalTrials.gov)
February 200724/1/2007A Study of E2007 In Patients With Parkinson's DiseaseA Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLTerminated18 YearsN/AAll25Phase 2United States
1435NCT00480701
(ClinicalTrials.gov)
February 200730/5/2007Evaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT Imaging of Healthy Subjects and Patients With Alzheimer DiseaseEvaluation of 123-I Iodobenzovesamicol (IBVM) and SPECT as a Marker of Acetylcholine Transporter Density in the Brain of Healthy Subjects and Patients With Alzheimer DiseaseAlzheimer Disease;Parkinson DiseaseDrug: [123I]-IBVMInstitute for Neurodegenerative DisordersNULLCompleted50 YearsN/ABoth26Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1436NCT00332917
(ClinicalTrials.gov)
February 20071/6/2006An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD PatientsAn Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD PatientsEarly Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth224Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro
1437EUCTR2006-003732-30-DE
(EUCTR)
31/01/200729/11/2006Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1Transdermal Use of Lisuride in Early Parkinson´s Disease: A double blind, randomized, Placebo and Pramipexole controlled study to evaluate the efficacy and safety of Lisuride TTS - TULEP 1 Early Parkinson's Disease
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Product Name: Lisuride TTS 10cm²
INN or Proposed INN: LISURIDE
Trade Name: Sifrol 0,088
INN or Proposed INN: PRAMIPEXOLE
Product Name: Lisuride TTS 20cm²
INN or Proposed INN: LISURIDE
Trade Name: Sifrol 0,18
INN or Proposed INN: PRAMIPEXOLE
Trade Name: Sifrol 0,35
INN or Proposed INN: PRAMIPEXOLE
Trade Name: Sifrol 0,7
INN or Proposed INN: PRAMIPEXOLE
Axxonis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Germany;Italy;Poland
1438EUCTR2006-000859-18-NL
(EUCTR)
25/01/200705/04/2007An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
247Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1439EUCTR2006-002339-26-HU
(EUCTR)
24/01/200724/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1440EUCTR2006-000678-57-FR
(EUCTR)
09/01/200710/10/2006A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;Estonia;France;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1441EUCTR2006-000859-18-PT
(EUCTR)
04/01/200718/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1442NCT01187966
(ClinicalTrials.gov)
January 200731/5/2010Efficacy and Safety of Safinamide (50 and 100mg/Day) Versus Placebo, in Patients With Mid-late Stage Parkinson's DiseaseA Phase III, Double-blind, Placebo-controlled Study to Determine the Efficacy and Safety of a Low (50 mg/Day) and High (100 mg/Day) Dose of Safinamide, as add-on Therapy, in Patients With Idiopathic Parkinson's Disease With Motor Fluctuations, Treated With a Stable Dose of Levodopa and Who May be Receiving Concomitant Treatment With Stable Doses of a Dopamine Agonist, and/or an AnticholinergicParkinson's DiseaseDrug: Safinamide;Drug: PlaceboNewronNULLCompleted30 Years80 YearsBoth669Phase 3NULL
1443NCT00640159
(ClinicalTrials.gov)
January 200718/3/2008Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's DiseaseTolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease.Parkinson's DiseaseDrug: ZelaparBaylor College of MedicineNULLCompleted30 Years90 YearsBoth55Phase 4United States
1444NCT00855686
(ClinicalTrials.gov)
January 20073/3/2009Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy BodiesA Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy BodiesParkinson's Disease Dementia;Dementia With Lewy BodiesDrug: Memantine;Drug: PlaceboH. Lundbeck A/SNULLCompleted50 YearsN/ABoth199Phase 4Germany
1445NCT00465452
(ClinicalTrials.gov)
January 200724/4/2007Impact of Switching to Continuous Release Dopamine AgonistsThe Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side EffectsParkinson DiseaseDrug: Continuous Release Dopamine AgonistsUniversity of Toledo Health Science CampusNULLCompleted55 YearsN/ABoth15Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1446EUCTR2006-000678-57-PT
(EUCTR)
29/12/200610/08/2006A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1447EUCTR2005-002654-21-NO
(EUCTR)
28/12/200606/11/2006A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNEA long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.Trade Name: Duodopa intestinalgel
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
75Norway;Sweden
1448EUCTR2006-002339-26-GB
(EUCTR)
28/12/200616/10/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1449EUCTR2006-000678-57-DE
(EUCTR)
22/12/200606/10/2006A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
376Portugal;United Kingdom;Czech Republic;Germany;Netherlands;France;Estonia;Italy;Lithuania
1450EUCTR2006-005509-79-GB
(EUCTR)
21/12/200607/12/2006A Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s DiseaseA Clinic-Based, Phase IIa, Randomised, Double-Blind, Placebo-Controlled, Ascending-Dose, Multicentre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040 in Patients with Established Idiopathic Parkinson’s Disease Idiopathic Parkinson's Disease patients who have motor fluctuations with recognisable motor off” periodsProduct Name: apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1451EUCTR2006-005860-14-IT
(EUCTR)
19/12/200617/03/2009A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - NDA phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50 mg/day) and high (100 mg/day) dose of safinamide, as add-on therapy, in patients with idiopathic parkinson?s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist and/or an anticholinergic - ND PATIENTS WITH IDIOPATHIC PARKINSON?S DISEASE WITH MOTOR FLUCTUATIONS
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015
NEWRON PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Italy
1452EUCTR2006-003490-27-GB
(EUCTR)
19/12/200629/09/2006A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with LevodopaA Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Single and Multiple Oral Dose Administration of BIIB014 in Subjects with Moderate to Late Stage Parkinson’s Disease Who Are Also Receiving Treatment with Levodopa Parkinson's disease
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
BIOGEN IDEC LTDNULLNot Recruiting Female: yes
Male: yes
137Phase 2United Kingdom
1453EUCTR2005-000314-12-DE
(EUCTR)
19/12/200625/01/2007Effect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPIEffect of 3 doses ( 20, 40 and 60 mg) of a sublingual formulation of piribedil ( S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson's disease patients after a 14 day treatment-period ( one administration t.i.d). A randomized, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI Parkinson's Disease aggravated
MedDRA version: 7.0;Level: LLT;Classification code 10034006
Product Name: S90049
Product Code: S90049
INN or Proposed INN: piribedil
Product Name: S90049
Product Code: S90049
INN or Proposed INN: piribedil
Institut de Recherches Internationales ServierNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Spain;Germany
1454EUCTR2006-000858-45-FI
(EUCTR)
18/12/200626/06/2006An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Finland;Sweden
1455EUCTR2006-002339-26-IT
(EUCTR)
16/12/200605/06/2007Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303Studio di Estensione Multi-centrico, in Aperto per Valutare Sicurezza, Tollerabilita' ed Efficacia a Lungo Termine di E2007 come Terapia Aggiuntiva in Pazienti affetti da Morbo di Parkinson con Fluttuazioni Motorie Trattati con Levodopa. - E2007-G000-303 Levodopa treated Parkinson's Disease Patients with Motor Fluctuations
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: E2007EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
1400Phase 3Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1456EUCTR2006-002937-20-CZ
(EUCTR)
14/12/200624/10/2006A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1457EUCTR2006-002937-20-EE
(EUCTR)
11/12/200619/10/2006A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1458EUCTR2006-005140-89-NL
(EUCTR)
11/12/200601/12/2006A PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge studyA PHASE I, DOUBLE BLIND, PLACEBO CONTROLLED, RANDOMIZED (WITHIN EACH GROUP) STUDY TO EVALUATE THE INTERACTION BETWEEN ORALLY ADMINISTERED TYRAMINE HYDROCHLORIDE AND RASAGILINE MESILATE IN HEALTHY SUBJECTS - Tyramine challenge study This postmarketing Phase I study is performed in healthy volunteers. The IMP rasagiline 1mg is indicated for the treatment of Parkinson's Disease (PD).
MedDRA version: 9.1;Level: PT;Classification code 10061536
Trade Name: Selegiline HCl 5 PCH
Trade Name: Nardil
Product Name: Rasagiline 1mg tablet
Product Code: TVP-1012
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesilate
Product Name: Rasagiline 2 mg tablet
Product Code: TVP-1012
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesilate
TEVA Pharmaceuticals Industries LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 1Netherlands
1459EUCTR2006-002937-20-LT
(EUCTR)
04/12/200602/11/2006A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
INN or Proposed INN: entacapone
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1460EUCTR2005-002038-36-FR
(EUCTR)
01/12/200624/08/2010A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy BodiesA randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies Patients with Parkinson’s disease dementia or dementia with Lewy BodiesTrade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
H. Lundbeck A/SNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Germany;United Kingdom;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1461NCT01631812
(ClinicalTrials.gov)
December 200625/6/2012A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll130Phase 2Japan
1462NCT01964573
(ClinicalTrials.gov)
December 200614/10/2013Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in Healthy Korean SubjectsA Single-site, Randomized, Double-blind, Placebo-controlled, Repeated-dose Trial to Evaluate the Pharmacokinetics, Safety, and Tolerability of Rotigotine in 2 Different Dosages (2 mg / 24 Hours [10 cm2], 4 mg / 24 Hours [20 cm2]) in Healthy Korean SubjectsParkinson's DiseaseDrug: Rotigotine;Other: PlaceboUCB PharmaNULLCompleted19 Years45 YearsBoth48Phase 1Korea, Republic of
1463NCT00036296
(ClinicalTrials.gov)
December 20068/5/2002Effects of Talampanel on Patients With Advanced Parkinson's DiseaseEffects of Talampanel on Patients With Advanced Parkinson's Disease Who Have Been on Sinemet for More Than 5 Years and Have Dyskinesia (Abnormal Involuntary Movements)Dyskinesias;Parkinson Disease;Movement DisordersDrug: talampanelTeva Pharmaceutical IndustriesNULLCompleted40 Years85 YearsBoth22Phase 1;Phase 2United States;Canada
1464NCT00853879
(ClinicalTrials.gov)
December 200626/2/2009An Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's DiseaseAn Exploratory, Randomized, Blinded, Placebo-Controlled Trial of Folic Acid and L-methylfolate in Parkinson's DiseaseParkinson's DiseaseDietary Supplement: Folic Acid, Vitamin B6, Vitamin B12;Dietary Supplement: B6, B12, L-methylfolate;Dietary Supplement: B6, B12, PlaceboNorth Shore Long Island Jewish Health SystemNULLTerminated30 YearsN/ABoth150N/AUnited States
1465EUCTR2005-002038-36-DE
(EUCTR)
29/11/200619/01/2007A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy BodiesA randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies Patients with Parkinson’s disease dementia or dementia with Lewy BodiesTrade Name: Ebixa
Product Name: Memantine
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Product Name: Memantine
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Memantine
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Product Name: Memantine
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
H. Lundbeck A/SNULLNot RecruitingFemale: yes
Male: yes
200United Kingdom;Germany;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1466EUCTR2006-001755-36-GB
(EUCTR)
20/11/200629/09/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Orion Corporation Orion PharmaNULLNot Recruiting Female: yes
Male: yes
100Phase 4Germany;United Kingdom;Sweden
1467NCT00406029
(ClinicalTrials.gov)
November 20, 200630/11/2006Dyskinesia in Parkinson's Disease (Study P04501)A Phase 2, 12-Week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a Range of SCH 420814 Doses in Subjects With Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and DyskinesiasParkinson Disease;Movement Disorders;Central Nervous System Diseases;Neurodegenerative Diseases;Brain DiseasesDrug: Preladenant;Drug: Placebo;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll253Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Italy;New Zealand;Peru;Singapore;South Africa;Spain;United States
1468EUCTR2006-000678-57-GB
(EUCTR)
14/11/200630/05/2007A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Solvay pharmaceuticalsNULLNot Recruiting Female: yes
Male: yes
330Phase 3France;Portugal;Estonia;Czech Republic;Lithuania;Netherlands;Germany;Italy;United Kingdom
1469EUCTR2006-004112-51-IT
(EUCTR)
14/11/200604/12/2006A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - NDA randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND Parkinson s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: SIRIO*30CPR EFF 25MG+100MG
INN or Proposed INN: Melevodopa and decarboxylase inhibitor
Trade Name: SINEMET*50CPR 100MG+25MG
INN or Proposed INN: LEVODOPA DC.IT FU
INN or Proposed INN: CARBIDOPA FU
VERNALIS DEVELOPMENT LIMITEDNULLNot RecruitingFemale: yes
Male: yes
Italy
1470EUCTR2006-001793-24-PT
(EUCTR)
07/11/200631/07/2006A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableA MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.
MedDRA version: 7;Level: LLT;Classification code 10061536
Product Name: Nebicapone
Product Code: BIA 3-202
Trade Name: COMTAN®
Product Name: Entacapone
INN or Proposed INN: Entacapone
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Nebicapone
Product Code: BIA 3-202
BIAL - Portela & Cª, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1471EUCTR2006-000678-57-LT
(EUCTR)
07/11/200607/09/2006A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1472EUCTR2006-000859-18-LT
(EUCTR)
07/11/200607/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1473EUCTR2006-004582-33-GB
(EUCTR)
03/11/200623/01/2012A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s DiseaseA Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Escalating Study Investigating the Efficacy and Safety of VR040 in the Treatment of Unpredictable Off” or End-of-Dose Wearing Off” Episodes in Patients With Advanced Idiopathic Parkinson’s Disease Hypomobility (off or freezing) episodes associated with advanced Parkinson's diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
48Phase 2United Kingdom
1474EUCTR2006-000678-57-EE
(EUCTR)
03/11/200601/09/2006A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1475EUCTR2006-000859-18-EE
(EUCTR)
03/11/200601/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1476EUCTR2006-002339-26-CZ
(EUCTR)
01/11/200621/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1477EUCTR2006-002937-20-LV
(EUCTR)
01/11/200602/11/2006A Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo- and Entacapone-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Trade Name: Comtess
Product Name: Entacapone
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
702Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Lithuania
1478NCT00335166
(ClinicalTrials.gov)
November 20068/6/2006SLV 308 and Pramipexole for Treatment of Patients With Early Parkinson DiseaseA Multicenter, Randomized, Double Blind, Parallel-Group Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's Disease.Early Stage Parkinson DiseaseDrug: Pardaprunox;Drug: pramipexole;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth330Phase 3United States;Australia;Czech Republic;Estonia;France;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Spain;Taiwan;Thailand;United Kingdom
1479NCT00400634
(ClinicalTrials.gov)
November 200615/11/2006Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's DiseaseMulticenter, Randomized, Double-Blind, Sham Surgery-Controlled Study of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) to Assess the Efficacy and Safety of Bilateral Intraputaminal (IPu) Delivery in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]);Procedure: Sham SurgeryCeregeneNULLCompleted35 Years75 YearsAll58Phase 2United States
1480NCT00402233
(ClinicalTrials.gov)
November 200619/11/2006A Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over 12-week Treatment in Early Parkinson's Disease (PD) PatientsA Randomized, Double-blind, Active (Pramipexole 0.5 mg Tid) and Placebo Controlled, Efficacy Study of Pramipexole Given 0.5 mg and 0.75 mg Bid Over a 12-week Treatment Phase in Early Parkinson's Disease Patients (PramiBID)Parkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted31 YearsN/AAll312Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1481NCT00468078
(ClinicalTrials.gov)
November 200630/4/2007Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor PatientsThe Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor PatientsParkinson's DiseaseProcedure: PET/CT;Drug: F-18 FPCITAsan Medical CenterNULLCompleted40 YearsN/ABoth78Phase 3Korea, Republic of
1482NCT00360308
(ClinicalTrials.gov)
November 20062/8/2006Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo and Entacapone Controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: Placebo;Drug: E2007Eisai LimitedNULLTerminated30 YearsN/AAll723Phase 3France
1483EUCTR2005-002038-36-GB
(EUCTR)
31/10/200609/10/2006A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy BodiesA randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies Patients with Parkinson’s disease dementia or dementia with Lewy Bodies
MedDRA version: 8.1;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease
H. Lundbeck A/SNULLNot Recruiting Female: yes
Male: yes
200Phase 4France;Greece;Spain;Austria;Germany;Italy;United Kingdom
1484EUCTR2006-002339-26-EE
(EUCTR)
20/10/200615/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1485EUCTR2006-002339-26-SE
(EUCTR)
19/10/200622/09/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1486EUCTR2006-002339-26-BE
(EUCTR)
16/10/200624/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1487EUCTR2006-000858-45-SK
(EUCTR)
11/10/200628/09/2006An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochlo
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Finland;Sweden
1488EUCTR2006-002339-26-LT
(EUCTR)
05/10/200607/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1489NCT00399477
(ClinicalTrials.gov)
October 200610/11/2006A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's DiseaseOpen-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)Parkinson's DiseaseDrug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with RequipTeva Neuroscience, Inc.NULLCompleted30 YearsN/ABoth200Phase 4United States
1490NCT00391898
(ClinicalTrials.gov)
October 200624/10/2006Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-offA 3-month, Multi-center, Double-blind, Randomized Study to Evaluate the Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Impairment of Activities of Daily Living and Early Wearing-off With LevodopaParkinson's DiseaseDrug: Levodopa/carbidopa/entacapone;Drug: Levodopa/carbidopaNovartisNULLCompleted30 Years80 YearsAll95Phase 4Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1491NCT00373087
(ClinicalTrials.gov)
October 20066/9/2006COMT Polymorphism and Entacapone EfficacyInfluence of Catechol-O-methyltransferase Polymorphism on Entacapone Efficacy in Parkinson's DiseaseParkinson's DiseaseDrug: entacapone;Drug: l dopa versus placeboAssistance Publique - Hôpitaux de ParisNULLCompleted30 YearsN/ABoth60Phase 4France
1492NCT00360412
(ClinicalTrials.gov)
October 20062/8/2006A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLTerminated30 YearsN/AMale997Phase 3Germany
1493NCT03103399
(ClinicalTrials.gov)
September 26, 200628/3/2017Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff PhenomenonA Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/BenserazideParkinson DiseaseDrug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: PlaceboBial - Portela C S.A.NULLCompleted30 Years80 YearsAll254Phase 2NULL
1494EUCTR2006-002339-26-AT
(EUCTR)
25/09/200618/10/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
1495EUCTR2005-002038-36-AT
(EUCTR)
22/09/200609/10/2006A randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy BodiesA randomised, double-blind, placebo-controlled, 6-month study of the efficacy and safety of memantine in patients with Parkinson’s disease dementia or dementia with Lewy Bodies Patients with Parkinson’s disease dementia or dementia with Lewy BodiesTrade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
Trade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: MEMANTINE HYDROCHLORIDE
H. Lundbeck A/SNULLNot RecruitingFemale: yes
Male: yes
200Germany;United Kingdom;France;Spain;Italy;Greece;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1496EUCTR2006-000678-57-IT
(EUCTR)
14/09/200626/06/2007A multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - NDA multicenter, randomized, double-blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson's Disease. - ND Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: SLV308 (mono)hydrochloride
Product Code: SLV308
Product Name: Pramipexole
INN or Proposed INN: Pramipexole
Product Name: SLV308 (mono)hydrochloride
Product Code: SLV308
Product Name: SLV308 (mono)hydrochloride
Product Code: SLV308
Product Name: SLV308 (mono)hydrochloride
Product Code: SLV308
Product Name: SLV308 (mono)hydrochloride
Product Code: SLV308
Product Name: SLV308 (mono)hydrochloride
Product Code: SLV308
SOLVAY PHARMACEUTICALS B.V.NULLNot RecruitingFemale: yes
Male: yes
390Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
1497EUCTR2005-005146-39-IT
(EUCTR)
14/09/200606/12/2006A Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - NDA Phase-2, 12-week, Double-Blind, Dose-Finding, Placebo-Controlled Study to Assess the Efficacy and Safety of a range of SCH 420814 Doses 1 mg BID, 2 mg BID, 5 mg BID and Possibly 10 mg BID in Subjects With Moderate to Severe Parkinson s Disease Experiencing Motor Fluctuations and Dyskinesias. - ND Moderate to severe Parkinson s disease with motor fluctuation and dyskinesias.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Code: SCH 420814
Product Code: SCH 420814
Schering Plough Research InstituteNULLNot RecruitingFemale: yes
Male: yes
160Phase -2Italy
1498EUCTR2006-000859-18-CZ
(EUCTR)
11/09/200602/08/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
1499EUCTR2005-004949-34-SE
(EUCTR)
06/09/200627/03/2006A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start StudyA randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study Parkinson's disease
MedDRA version: 6.1;Level: pref;Classification code 10061536
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden
1500EUCTR2005-001006-12-CZ
(EUCTR)
06/09/200624/08/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Axxonis Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Germany;Czech Republic;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1501EUCTR2004-005234-39-LV
(EUCTR)
06/09/200629/09/2006Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
1502EUCTR2005-005423-34-HU
(EUCTR)
04/09/200605/07/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1503NCT00462007
(ClinicalTrials.gov)
September 200617/4/2007Study to Evaluate Initiation of Stalevo in Early Wearing-offEfficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease PatientsParkinson's DiseaseDrug: StalevoOrion Corporation, Orion PharmaNULLCompleted35 YearsN/ABoth115Phase 4Germany;Sweden;United Kingdom
1504NCT00355927
(ClinicalTrials.gov)
September 200623/7/2006Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.Movement Disorders;Parkinson Disease;Parkinsonian Disorders;Dystonia;Tourette SyndromeProcedure: Sedation with IV propofolHadassah Medical OrganizationNULLEnrolling by invitationN/AN/ABoth20N/AIsrael
1505NCT00507715
(ClinicalTrials.gov)
September 200625/7/2007Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata HuskClinical Trial to Study the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata HuskParkinson's Disease, IdiopathicDrug: Plantago ovata husk;Other: hemicellulose crystallineRottapharm SpainNULLCompleted60 Years80 YearsBoth18Phase 1Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1506EUCTR2005-006033-32-SE
(EUCTR)
15/08/200622/06/2006A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt studyA Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
1507EUCTR2006-001755-36-SE
(EUCTR)
09/08/200630/06/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion Pharma, FI-02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
1508EUCTR2005-004314-33-PT
(EUCTR)
09/08/200610/05/2006A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Hungary;Portugal;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1509EUCTR2005-004949-34-DE
(EUCTR)
04/08/200630/03/2006A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start StudyA randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study Parkinson's disease
MedDRA version: 6.1;Level: pref;Classification code 10061536
Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: SIFROL
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1510EUCTR2006-000678-57-NL
(EUCTR)
03/08/200604/04/2007A multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer studyA multicenter, randomized, double blind, parallel-group placebo and pramipexole controlled study to assess efficacy and safety of SLV308 monotherapy in the treatment of patients with early stage Parkinson’s disease. - The Vermeer study Parkinson 's Disease early stage
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
330Portugal;United Kingdom;Germany;Czech Republic;Netherlands;France;Estonia;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1511NCT01628848
(ClinicalTrials.gov)
August 200624/6/2012A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease PatientsA Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962;Drug: PlaceboOtsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll174Phase 2Japan
1512NCT00368108
(ClinicalTrials.gov)
August 200622/8/2006Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy, Safety, and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: 2 mg perampanel;Drug: 4 mg perampanel;Drug: placebo comparatorEisai Inc.NULLCompleted30 YearsN/AAll752Phase 3United States;Canada
1513EUCTR2006-001793-24-AT
(EUCTR)
31/07/200624/07/2006A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not availableA MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI.
MedDRA version: 7;Level: LLT;Classification code 10061536
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Entacapone
INN or Proposed INN: Entacapone
Product Name: Nebicapone
Product Code: BIA 3-202
Product Name: Nebicapone
Product Code: BIA 3-202
BIAL - Portela & Cª, SANULLNot RecruitingFemale: yes
Male: yes
250Portugal;Austria
1514EUCTR2006-000391-32-NL
(EUCTR)
18/07/200610/05/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Germany;United Kingdom;Netherlands
1515NCT03097211
(ClinicalTrials.gov)
July 17, 200627/3/2017Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mgA Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mgParkinson DiseaseDrug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: NebicaponeBial - Portela C S.A.NULLCompleted18 Years45 YearsAll38Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1516EUCTR2006-003717-41-IT
(EUCTR)
13/07/200612/07/2007EVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - NDEVALUATE THE TOLERABILITY AND EFFICACY OF OMEGA 3 ON MOOD ANDMOTOR SYMPTOMS OF PATIENTS SUFFERING FROM PARKINSON DISEASE - ND MOOD DEPRESSION
MedDRA version: 6.1;Level: PT;Classification code 10012374
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLINULLNot RecruitingFemale: yes
Male: yes
Italy
1517EUCTR2006-000680-28-ES
(EUCTR)
07/07/200622/05/2006Estudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBIEstudio multicéntrico, doble ciego, aleatorizado y de tres meses de seguimiento para evaluar la eficacia de levodopa/carbidopa/entacapona frente a levodopa/carbidopa en pacientes con enfermedad de Parkinson y wearing-off”A 3-months, multicenter, double-blind, randomized study to evaluate the efficacy of levodopa/carbidopa/entacapone vs. levodopa/carbidopa in Parkinson's disease patients with 'wearing-off' - DERBI Enfermedad de Parkinson (Parkinson Disease)Trade Name: Stalevo 100
Product Name: Stalevo (levodopa/carbidopa/entacapona)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONA
Trade Name: Sinemet plus
Product Name: Sinemet plus (levodopa/carbidopa)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Trade Name: Stalevo 150
Product Name: Stalevo (levodopa/carbidopa/entacapona)
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONA
NOVARTIS FARMACEUTICA, S.ANULLNot RecruitingFemale: yes
Male: yes
200Spain
1518EUCTR2006-000391-32-DE
(EUCTR)
04/07/200627/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's DiseaseProduct Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Netherlands
1519NCT00408915
(ClinicalTrials.gov)
July 20065/12/2006Continuous Application of Lisuride in Parkinson's Disease by Subcutaneous InfusionDouble-blind, Placebo-controlled, Randomized, Multicentre Phase II/III Study to Evaluate the Efficacy and Safety of Lisuride, Applied Subcutaneously by Means of a Minipump in Patients With Advanced Parkinson's Disease Refractory to Conventional Oral TherapyParkinson's DiseaseDrug: Continuous Subcutaneous Lisuride InfusionAxxonis Pharma AGNULLCompleted18 Years75 YearsBoth60Phase 3Germany
1520NCT00346827
(ClinicalTrials.gov)
July 200629/6/2006Apomorphine Nasal Powder in the Treatment of Parkinson's Disease Off Periods.Parkinson's DiseaseDrug: Apomorphine Nasal PowderBritannia Pharmaceuticals Ltd.NULLCompleted18 Years85 YearsAll36Phase 2;Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1521EUCTR2006-000361-11-GB
(EUCTR)
23/06/200601/02/2006A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201)A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201) Treatment of Parkinson's Disease
MedDRA version: 8.0;Classification code 10029205
Fujimoto Pharmaceutical CorporationNULLNot Recruiting Female: yes
Male: yes
10Phase 2United Kingdom
1522EUCTR2005-004314-33-DE
(EUCTR)
21/06/200601/12/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;United Kingdom;Germany;Estonia;Spain;Italy;Lithuania;Sweden
1523NCT00331149
(ClinicalTrials.gov)
June 20, 200626/5/2006A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson'sA Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.Parkinson DiseaseDrug: Ropinirole prolonged release;Drug: ropinirole immediate releaseGlaxoSmithKlineNULLCompleted30 YearsN/AAll343Phase 3Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
1524EUCTR2005-004949-34-GB
(EUCTR)
19/06/200624/03/2006 A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease The main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study Parkinson's disease
MedDRA version: 6.1;Level: pref;Classification code 10061536
Boehringer Ingelheim LtdNULLNot Recruiting Female: yes
Male: yes
500Phase 4Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1525EUCTR2005-005423-34-DE
(EUCTR)
19/06/200602/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1526EUCTR2005-006033-32-SK
(EUCTR)
13/06/200602/05/2006A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt studyA Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
1527EUCTR2006-000391-32-GB
(EUCTR)
06/06/200621/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Netherlands;Germany;United Kingdom
1528NCT00269516
(ClinicalTrials.gov)
June 200622/12/2005SLV308 for Treatment of Patients With Early Parkinson's DiseaseA Randomized, Double Blind, Placebo Controlled Parallel-Group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients With Early Stage Parkinson's DiseaseEarly Stage Parkinson's DiseaseDrug: pardoprunox;Drug: Pardoprunox;Drug: PlaceboSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth468Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro
1529EUCTR2005-004949-34-ES
(EUCTR)
29/05/200621/04/2006A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start StudyA randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s disease. Protocol includes DAT SPECT of a sub-set of patients Estudio aleatorizado, doble ciego, controlado con placebo, para examinar la eficacia y seguridad del tratamiento temprano frente al tratamiento retrasado con pramipexol en pacientes con inicio de Parkinson - Pramipexole Early Start Study Parkinson's disease
MedDRA version: 6.1;Level: pref;Classification code 10061536
Trade Name: Sifrol, Mirapexin
Product Name: Sifrol, Mirapexin
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol, Mirapexin
Product Name: Sifrol, Mirapexin
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol, Mirapexin
Product Name: Sifrol, Mirapexin
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
500Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1530EUCTR2005-005423-34-ES
(EUCTR)
19/05/200629/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKlineNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1531EUCTR2005-004314-33-ES
(EUCTR)
19/05/200615/03/2006A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Eisai LimitedNULLNot Recruiting Female: yes
Male: yes
1260Phase 3Portugal;Czech Republic;Hungary;Estonia;Belgium;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1532EUCTR2005-005423-34-GB
(EUCTR)
11/05/200617/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseGlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
516Phase 3Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
1533EUCTR2004-005234-39-LT
(EUCTR)
09/05/200624/03/2006Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
244Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Sweden;Lithuania
1534EUCTR2005-005423-34-IT
(EUCTR)
08/05/200603/10/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - NDA Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - ND Parkinson disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: ropinirole PR/XR tablets
Product Code: SKF-101468A
INN or Proposed INN: Ropinirole
Trade Name: REQUIP*21CPR 0,25MG
INN or Proposed INN: Ropinirole
Product Name: ropinirole PR/XR tablets
Product Code: SKF-101468A
INN or Proposed INN: Ropinirole
Product Name: ropinirole PR/XR tablets
Product Code: SKF-101468A
INN or Proposed INN: Ropinirole
Trade Name: REQUIP*21CPR 0,5MG
INN or Proposed INN: Ropinirole
Trade Name: REQUIP*21CPR 1MG
INN or Proposed INN: Ropinirole
GlaxoSmithKline R DNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
1535NCT00321854
(ClinicalTrials.gov)
May 20063/5/2006Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.Parkinson DiseaseDrug: pramipexoleBoehringer IngelheimNULLCompleted30 Years79 YearsAll535Phase 4United States;Austria;Finland;France;Germany;Italy;Japan;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1536NCT00329056
(ClinicalTrials.gov)
May 200622/5/2006A Trial of MitoQ for the Treatment of People With Parkinson's DiseaseA Double-Blind, Prospective, Randomized Comparison of 2 Doses of MitoQ and Placebo for the Treatment of Patients With Parkinson's DiseaseParkinson's DiseaseDrug: MitoQAntipodean Pharmaceuticals, Inc.NULLCompleted30 YearsN/ABoth128Phase 2Australia;New Zealand
1537NCT03094156
(ClinicalTrials.gov)
April 26, 200623/3/2017Effect of BIA 6-512 at Steady-state on the Levodopa PharmacokineticsA Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mgParkinson DiseaseDrug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan®Bial - Portela C S.A.NULLCompleted18 Years45 YearsAll39Phase 1Portugal
1538EUCTR2005-005791-32-GB
(EUCTR)
24/04/200617/02/2006Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.
MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)
Hunter-Fleming LtdNULLNot Recruiting Female: yes
Male: yes
40Phase 2United Kingdom;Sweden
1539EUCTR2005-005423-34-CZ
(EUCTR)
20/04/200603/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Germany;Czech Republic;Spain;Italy
1540EUCTR2005-006033-32-FI
(EUCTR)
20/04/200606/03/2006A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt studyA Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1541EUCTR2005-004949-34-AT
(EUCTR)
18/04/200621/03/2006A randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start StudyA randomized, double-blind, placebo-controlled, parallel-group clinical trial to examine the efficacy and safety of early pramipexole treatment versus delayed pramipexole treatment in patients with new onset Parkinson’s diseaseThe main protocol includes DAT SPECT brain imaging of a sub-set of patients - Pramipexole Early Start Study Parkinson's disease
MedDRA version: 6.1;Level: pref;Classification code 10061536
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Austria GmbHNULLNot RecruitingFemale: yes
Male: yes
500Finland;Germany;United Kingdom;Spain;Italy;Austria;Sweden
1542EUCTR2005-001006-12-AT
(EUCTR)
02/04/200628/02/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Trade Name: Sifrol, 0,35 mg Tablette
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Trade Name: Sifrol, 0,70 mg Tablette
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Trade Name: Cabaseril, 1,0 mg Tablette
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Trade Name: Cabaseril, 2,0 mg Tablette
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]-
Axxonis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Germany;Czech Republic;Italy;Austria
1543NCT00349310
(ClinicalTrials.gov)
April 20065/7/2006Profile of Depressive Symptoms in Parkinsons DiseaseProfile of Depressive Symptoms in Parkinson's Disease (PRODEST-PD)Parkinson Disease;DepressionDrug: PramipexoleBoehringer IngelheimNULLCompleted18 YearsN/ABoth1018Austria;France;Germany;Italy;Netherlands;Spain;Switzerland;United Kingdom
1544EUCTR2005-004109-27-SE
(EUCTR)
24/03/200624/01/2006A double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDDA double-blind, placebo-controlled multi-centre trial of memantine in patients with Parkinsons’ disease dementia or dementia with Lewy bodies - MEMDLBPDD Parkinsons disease (PD)and dementia with Lewy bodies (DLB) are both common disease of the elderly. The majority of patients who survive for more than 10 years with PD eventually develope dementia (PDD). The brain changes and clinical presentations of PDD and DLB are similar. The clinical characteristics are cognitive impairment with pronounced visuospatial and executive impairment, visual hallucinations, parkinsonism, fluctuations in cognition and REM sleep disorder.Trade Name: Ebixa
Product Name: Ebixa
Neuropsychiatric clinicNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Sweden
1545EUCTR2005-001032-72-PT
(EUCTR)
23/03/200611/11/2005A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First StepA 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step Parkinson diseaseTrade Name: Stalevo
Product Code: ELC200
INN or Proposed INN: levodopa/carbidopa/entacapone
Trade Name: SINEMET
Product Name: sinemet
INN or Proposed INN: levodopa/carbidopa
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1546EUCTR2005-001006-12-DE
(EUCTR)
09/03/200605/09/2006Double-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSODouble-blind, placebo-controlled, randomized, multicentre Phase II / III study to evaluate the efficacy and safety of Lisparin®, applied subcutaneously by means of a minipump in patients with advanced Parkinson’s Disease refractory to conventional oral therapy. - CALIPSO Patients with advanced Parkinson’s disease with motor fluctuations and OFF” periods refractory to conventional treatment.
MedDRA version: 9.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated
Product Name: Lisparin
INN or Proposed INN: Lisuride Hydrogenmaleate
Other descriptive name: 3- (9,10- Didehydro- 6- methyl- 8?- ergolinyl)-1,1- diethylurea hydrogenmaleate
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Pramipexol
INN or Proposed INN: Pramipexol
Other descriptive name: (S)- 2- Amino- 4,5,6,7- tetrahydro- 6- (propylamino)benzothiazol
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Product Name: Cabergoline
INN or Proposed INN: Cabergoline
Other descriptive name: 1[(6- Allyl- 8ß- ergolinyl)carbonyl]- 1- [3- (dimethylamino)propyl]- 3- ethylurea
Axxonis Pharma GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Germany;Italy;Austria
1547EUCTR2005-003788-22-SE
(EUCTR)
03/03/200619/12/2005A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptomsTrade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
354Phase 1Finland;Germany;United Kingdom;Spain;Italy;Sweden
1548EUCTR2005-004314-33-GB
(EUCTR)
01/03/200629/11/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Eisai LimitedNULLNot Recruiting Female: yes
Male: yes
1260Phase 3Portugal;Czech Republic;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1549EUCTR2005-004314-33-HU
(EUCTR)
01/03/200620/12/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1550NCT00282152
(ClinicalTrials.gov)
March 200623/1/2006Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)Safety and Tolerability of Neurostimulation in Early Stage Parkinson's DiseaseParkinson's DiseaseDevice: B-STN DBS;Drug: Optimal drug therapyVanderbilt University Medical CenterNULLCompleted50 Years75 YearsAll37N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1551NCT00393562
(ClinicalTrials.gov)
March 200626/10/2006Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's DiseaseComparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: modafinil;Drug: methylphenidateDepartment of Veterans AffairsNULLWithdrawn50 Years80 YearsBoth0N/AUnited States
1552NCT00305331
(ClinicalTrials.gov)
March 200620/3/2006Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's DiseasePhase II Clinical Trial of Domperidone as a Treatment for Dopamine Agonist-induced Peripheral Edema in Patients With Parkinson's DiseaseParkinson's Disease;Peripheral EdemaDrug: Domperidone (drug)University Health Network, TorontoNULLTerminated30 Years90 YearsBoth25Phase 2Canada
1553NCT00141518
(ClinicalTrials.gov)
March 200630/8/2005Long-term Study of Duodopa (Levodopa/Carbidopa) in Advanced Parkinson's: Health Outcomes & Net Economic ImpactA Long-term Health Economics Study of Intraduodenal Levodopa (Duodopa®) in Routine Care for Patients With Advanced Idiopathic Parkinson's Disease With Severe Motor Fluctuations and Hyper-/DyskinesiaAdvanced Idiopathic Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel (LCIG);Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: percutaneous endoscopic gastrostomy tube (PEG tube);Device: jejunal extension tube (J-tube)AbbVie (prior sponsor, Abbott)NULLCompleted18 Years99 YearsAll77Phase 4Norway;Sweden
1554NCT00297778
(ClinicalTrials.gov)
March 200628/2/2006Pramipexole Versus Placebo in Parkinson's Disease (PD) Patients With Depressive SymptomsA Randomized, Double-blind, Placebo-controlled, Parallel Group Efficacy Study of Pramipexole and Placebo Administered Orally Over a 12 Week Treatment Phase in Parkinson's Disease Patients With Stable Motor Function and Depressive SymptomsParkinson Disease;DepressionDrug: Pramipexole;Other: PlaceboBoehringer IngelheimNULLCompleted30 Years80 YearsAll296Phase 4Austria;Finland;France;Germany;Italy;Netherlands;Norway;Romania;Russian Federation;South Africa;Spain;Sweden;Ukraine;United Kingdom
1555EUCTR2005-003788-22-AT
(EUCTR)
22/02/200618/01/2006A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptomsTrade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Austria GmbHNULLNot RecruitingFemale: yes
Male: yes
318Phase 1Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1556EUCTR2005-001032-72-CZ
(EUCTR)
16/02/200612/01/2006A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First StepA 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step Trade Name: Stalevo 100 mg/25 mg / 200 mg
Product Code: ELC200
Trade Name: SINEMET CR
Product Name: SINEMET CR
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
1557EUCTR2005-003788-22-ES
(EUCTR)
09/02/200628/12/2005A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivosA randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.Estudio aleatorizado, doble ciego, controlado con placebo sobre la eficacia de pramipexol y placebo administrados por vía oral durante una fase de tratamiento de 12 semanas en pacientes con Parkinson con función motora estable y síntomas depresivos A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptomsTrade Name: Mirapexin / Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Mirapexin/Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Mirapexin/Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Mirapexin/Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
318Phase 1Finland;Germany;United Kingdom;Spain;Italy;Sweden
1558EUCTR2005-004290-19-GB
(EUCTR)
03/02/200609/01/2006A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's diseaseA double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease advanced-stage, idiopathic Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536
Schwarz Biosciences GmbHNULLNot Recruiting Female: yes
Male: yes
100Phase 2Spain;Austria;Germany;United Kingdom
1559EUCTR2005-004314-33-SE
(EUCTR)
03/02/200613/12/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1560EUCTR2005-004314-33-BE
(EUCTR)
02/02/200624/11/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1561EUCTR2005-004314-33-LT
(EUCTR)
01/02/200603/01/2006A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Sweden;Lithuania
1562EUCTR2005-004314-33-CZ
(EUCTR)
01/02/200611/01/2006A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Estonia;Czech Republic;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1563EUCTR2005-003788-22-DE
(EUCTR)
01/02/200607/12/2005A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptomsTrade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
354Phase 1Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
1564NCT00296192
(ClinicalTrials.gov)
February 200622/2/2006Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of Parkinson SymptomsA Double-Blind, Placebo-Controlled, Parallel-Group, Proof of Concept Trial to Assess the Tolerability, Safety, and Efficacy of Rotigotine Nasal Spray for the Acute Treatment of OFF Symptoms in Subjects With Advanced-Stage, Idiopathic Parkinson DiseaseParkinson's DiseaseDrug: Rotigotine nasal spray;Other: PlaceboUCB PharmaNULLCompleted30 YearsN/AAll82Phase 2Germany
1565NCT00286897
(ClinicalTrials.gov)
February 20063/2/2006The Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai LimitedNULLCompleted30 YearsN/ABoth702Phase 3Austria;Belgium;Czech Republic;Estonia;France;Germany;Hungary;Israel;Italy;Lithuania;Poland;Portugal;Serbia;South Africa;Spain;Sweden;United Kingdom;Former Serbia and Montenegro
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1566EUCTR2005-004314-33-IT
(EUCTR)
31/01/200607/09/2007A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - NDA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. - ND Parkinson's Desease patients with Motor Fluctuations who are on optimised and stabilised therapy with Levodopa.
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: E2007
Product Name: E2007
EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
900Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1567EUCTR2005-004290-19-DE
(EUCTR)
25/01/200605/12/2005A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's diseaseA double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease advanced-stage, idiopathic Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536
Product Name: Rotigotine Nasal Spray
Product Code: ND1421
INN or Proposed INN: Rotigotine hydrochloride
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Spain
1568NCT03095105
(ClinicalTrials.gov)
January 24, 200623/3/2017Pharmacokinetic Profile of BIA 6-512 in Healthy Elderly Subjects Versus Healthy Young SubjectsAn Open-label, Parallel-group Study to Compare the Pharmacokinetic Profile in Healthy Elderly Subjects Versus Healthy Young Subjects After Single and Repeated Oral Administration of BIA 6-512 (Trans-resveratrol)Parkinson DiseaseDrug: 200 mg BIA 6-512Bial - Portela C S.A.NULLCompleted18 YearsN/AAll25Phase 1Germany
1569EUCTR2005-004314-33-EE
(EUCTR)
17/01/200624/11/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Germany;United Kingdom;Estonia;Spain;Italy;Lithuania;Sweden
1570EUCTR2005-003788-22-GB
(EUCTR)
06/01/200611/11/2005A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms.A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptoms. A randomized, double-blind, placebo-controlled, parallel group, efficacy study of pramipexole and placebo administered orally over a 12-week treatment phase in Parkinson’s disease patients with stable motor function and depressive symptomsTrade Name: Sifrol
Product Name: Sifrol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Sifol
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
318Phase 4Finland;Spain;Austria;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1571NCT00279825
(ClinicalTrials.gov)
January 200618/1/2006Comparison of IPX054, IR Carbidopa-Levodopa, and CR Carbidopa-Levodopa in Subjects With Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Compare IPX054 200 mg and 250 mg to CD-LD IR 200 (2x100) mg Tablets and CD-LD CR 200 mg Tablet in Subjects With Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: CD-LD IR;Drug: CD-LD CR;Drug: IPX054 200 mg Placebo;Drug: IPX054 250 mg Placebo;Drug: CD-LD IR Placebo;Drug: CD-LD CR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll16Phase 2United States
1572NCT00292227
(ClinicalTrials.gov)
January 200614/2/2006Cardiac Effects of Rotigotine Transdermal System in Subjects With Advanced-stage Idiopathic Parkinson's DiseaseDouble-blind, Randomized, Placebo- and Positive-controlled, Parallel-group Trial to Assess the Potential Electrocardiographic Effects of Rotigotine Transdermal System up to 120 cm2/54.0 mg/Day in Subjects With Advanced-stage Idiopathic Parkinson's Disease: A Thorough QT/QTc Trial.Parkinson's DiseaseDrug: Rotigotine;Other: Placebo;Drug: Moxifloxacin infusion;Other: Placebo infusionUCB PharmaNULLCompleted18 YearsN/AAll130Phase 1South Africa
1573NCT02772614
(ClinicalTrials.gov)
January 200612/5/2016Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and MetabolitesAn Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 3-202 and Metabolites Following a Single-dose Oral AdministrationParkinson's DiseaseDrug: BIA 3-202 (200 mg)Bial - Portela C S.A.NULLCompleted40 Years55 YearsMale4Phase 1Switzerland
1574EUCTR2005-005120-13-GB
(EUCTR)
21/12/200502/11/2005A clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s DiseaseA clinic based, Phase IIa, randomised, double-blind, placebo-controlled, ascending dose, single centre study investigating the safety, tolerability, efficacy, and pharmacokinetics of VR040 in patients with established idiopathic Parkinson’s Disease Hypomobility (off” or freezing”) episodes associated with advanced Parkinson’s diseaseProduct Name: Apomorphine hydrochloride
Product Code: VR040
INN or Proposed INN: apomorphine hydrochloride
Vectura Group plcNULLNot RecruitingFemale: yes
Male: yes
24Phase 2United Kingdom
1575EUCTR2005-002432-10-MT
(EUCTR)
25/11/200510/10/2005A multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s diseaseA multicenter, randomized, double-blind, placebo-controlled, ascending dose, parallel group study exploring effects of SLV308 up to 42 mg/day administered as an adjunctive therapy to l-dopa in patients with advanced stage Parkinson’s disease Parkinson Disease late stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
60Malta
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1576EUCTR2005-001032-72-IT
(EUCTR)
25/11/200526/03/2007A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. Parkinson s Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: ENTACAPONE INN
INN or Proposed INN: LEVODOPA INN
INN or Proposed INN: CARBIDOPA INN
Trade Name: Sinemet
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA ANIDRA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
1577EUCTR2005-000444-84-GB
(EUCTR)
23/11/200513/09/2005An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OAn open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
1578EUCTR2005-002010-38-DE
(EUCTR)
21/11/200510/02/2006Assessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot studyAssessment of the acceptability of a sublingual formulation of piribedil (S90049), 10 to 30 mg on request (maximum 5 times a day) on the top of L-dopa and a dopamine agonist in advanced Parkinson Disease patients with motor fluctuations: a 4-week open label pilot study Advanced Parkinson´s DiseaseProduct Name: Trivastal
Product Code: S 90049
INN or Proposed INN: Piribedil
Institut de Recherches Internationales Servier (I.R.I.S.)NULLNot RecruitingFemale: yes
Male: yes
80Germany
1579EUCTR2005-001416-42-PT
(EUCTR)
07/11/200525/08/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO Parkinson's Disease
MedDRA version: 7.1;Level: PT;Classification code 10061536
Trade Name: AZILECT
Product Name: rasagiline tablets
Product Code: TVP-1012
INN or Proposed INN: rasagiline
Other descriptive name: rasagiline mesilate
Teva Pharmaceuticals Industries LtDNULLNot RecruitingFemale: yes
Male: yes
1100Hungary;Portugal;Germany;United Kingdom;Spain;Italy
1580NCT00250393
(ClinicalTrials.gov)
November 20054/11/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's DiseasePlacebo-Controlled , Crossover , Double-Blind Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Monotherapy]Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Hakko Kirin Company, LimitedNULLCompleted30 YearsN/ABoth64Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1581NCT00253084
(ClinicalTrials.gov)
November 200511/11/2005Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 2United States
1582NCT00256204
(ClinicalTrials.gov)
November 200516/11/2005A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's DiseaseA Multi Center, Double Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease SubjectsParkinson's DiseaseDrug: Rasagiline Mesylate;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 Years80 YearsAll1174Phase 3Argentina;Austria;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom;United States
1583EUCTR2004-005234-39-IE
(EUCTR)
20/10/200516/08/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot Recruiting Female: yes
Male: yes
240Phase 4Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
1584EUCTR2005-000314-12-ES
(EUCTR)
14/10/200508/09/2005Effect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPIEffect of 3 doses (20, 40 and 60 mg) of a sublingual formulation of piribedil (S 90049) in combination with levodopa on end-of-dose fluctuations in advanced Parkinson’s disease patients after a 14-day treatment-period (one administration t.i.d.). A randomised, double-blind study consisting of 3 cross-over: 40 mg versus placebo, 20 mg versus 60 mg and 40 mg versus 20 mg. - PARKOPI Parkinson's Disease aggravated
MedDRA version: 7.0;Level: LLT;Classification code 10034006
Product Name: piribedil
Product Code: S 90049 - F36
INN or Proposed INN: piribedil
Product Name: piribedil
Product Code: S 90049 - F38
INN or Proposed INN: piribedil
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Germany;Spain
1585NCT00199381
(ClinicalTrials.gov)
October 200512/9/2005An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.Parkinson's DiseaseDrug: IstradefyllineKyowa Kirin Pharmaceutical Development, Inc.NULLTerminated30 YearsN/AAll504Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1586NCT00134251
(ClinicalTrials.gov)
October 200522/8/2005Ascending Dose Tolerability/Safety of SLV308 for the Treatment of Parkinson's DiseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Parallel Group Study Exploring Effects of SLV308 up to 42 mg/Day Administered as an Adjunctive Therapy to L-Dopa in Patients With Advanced Stage Parkinson's DiseaseParkinson's DiseaseDrug: SLV308Solvay PharmaceuticalsNULLCompleted30 YearsN/ABothPhase 3Bulgaria;Malta;Serbia;Former Serbia and Montenegro
1587NCT00239564
(ClinicalTrials.gov)
October 200513/10/2005Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's DiseaseAn Open-Label Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX054 in Subjects With Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: IPX054 100 mg;Drug: IPX054 150 mg;Drug: IPX054 200 mg;Drug: IPX054 250 mg;Drug: IPX054 300 mgImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 1;Phase 2United States
1588NCT00912808
(ClinicalTrials.gov)
October 20052/6/2009Cholinergic Augmentation in Frequently Falling Subjects With Parkinson's DiseaseA Study of Cholinergic Augmentation in Frequently Falling Subjects With Parkinson'sParkinson's DiseaseDrug: Donepezil;Drug: Sugar Pill (placebo)Oregon Health and Science UniversityNULLCompleted21 YearsN/AAll23N/ANULL
1589EUCTR2005-001416-42-HU
(EUCTR)
27/09/200520/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO Parkinson's Disease
MedDRA version: 7.1;Level: PT;Classification code 10061536
Trade Name: AZILECT
Product Name: rasagiline tablets
Product Code: TVP-1012
INN or Proposed INN: rasagiline
Other descriptive name: rasagiline mesilate
Teva Pharmaceuticals Industries LtDNULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Hungary;Germany;United Kingdom;Spain;Italy
1590EUCTR2004-005234-39-FI
(EUCTR)
22/09/200503/06/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMANULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1591EUCTR2005-001416-42-GB
(EUCTR)
15/09/200513/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO Parkinson's Disease
MedDRA version: 7.1;Level: PT;Classification code 10061536
Teva Pharmaceuticals Industries LtDNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1592EUCTR2005-000444-84-FI
(EUCTR)
08/09/200526/07/2005An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OAn open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;United Kingdom;Spain;Italy
1593EUCTR2005-001416-42-DE
(EUCTR)
01/09/200517/10/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO Parkinson's Disease
MedDRA version: 7.1;Level: PT;Classification code 10061536
Product Name: rasagiline tablets
Product Code: TVP-1012
INN or Proposed INN: rasagiline
Other descriptive name: rasagiline mesilate
Product Name: rasagiline tablets
Product Code: TVP-1012
INN or Proposed INN: rasagiline
Other descriptive name: rasagiline mesilate
Product Name: rasagiline tablets
Product Code: TVP-1012
INN or Proposed INN: rasagiline
Other descriptive name: rasagiline mesilate
Teva Pharmaceuticals Industries LtDNULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Hungary;United Kingdom;Germany;Spain;Italy
1594NCT02778594
(ClinicalTrials.gov)
September 200518/5/2016Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/BenserazidePharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide (Madopar® HBS 125): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy VolunteersParkinson's Disease (PD)Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsBoth17Phase 1Portugal
1595NCT02774564
(ClinicalTrials.gov)
September 200513/5/2016Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/CarbidopaPharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single Dose of Controlled-release 200/50 mg Levodopa/Carbidopa (Sinemet® cr 200/50): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Sinemet®Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth16Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1596NCT00224263
(ClinicalTrials.gov)
September 200520/9/2005Efficacy and Safety of Lingzhi in Patients With Early Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of Lingzhi in Patients With Early Parkinson's Disease Receiving Stable L-dopa/DCIParkinson's DiseaseDrug: Lingzhi (Ganoderma)Xuanwu Hospital, BeijingNULLCompleted30 Years80 YearsBoth360Phase 2China
1597NCT00165789
(ClinicalTrials.gov)
September 200512/9/2005A Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor FluctuationsA Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Explore the Safety And Tolerability of Doses of E2007 Up to a Maximum of 8 mg In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing Off Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLCompleted18 YearsN/AAll75Phase 2United States
1598EUCTR2005-001416-42-AT
(EUCTR)
24/08/200520/07/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIOA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects - ADAGIO Parkinson's Disease
MedDRA version: 7.1;Level: PT;Classification code 10061536
Trade Name: AZILECT
Product Name: rasagiline tablets
Product Code: TVP-1012
INN or Proposed INN: rasagiline
Other descriptive name: rasagiline mesilate
Teva Pharmaceuticals Industries LtDNULLNot RecruitingFemale: yes
Male: yes
1100Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1599EUCTR2005-002654-21-SE
(EUCTR)
08/08/200514/06/2005A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNEA long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.Trade Name: Duodopa intestinal gel
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
Sweden
1600EUCTR2004-005234-39-DK
(EUCTR)
04/08/200531/05/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1601NCT00125567
(ClinicalTrials.gov)
August 200529/7/2005Stalevo in Early Wearing-Off PatientsMulticentre, Randomised, Double-Blind Study to Compare Stalevo to Levodopa/Carbidopa in Patients With Parkinson's Disease Experiencing Symptoms of Early Wearing-OffIdiopathic Parkinson's DiseaseDrug: Stalevo (levodopa/carbidopa/entacapone);Drug: Levodopa/carbidopaOrion Corporation, Orion PharmaNULLCompleted30 YearsN/ABoth223Phase 4Denmark;Finland;Germany;Ireland;Sweden;United Kingdom
1602NCT00134966
(ClinicalTrials.gov)
August 200523/8/2005A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaA 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring LevodopaParkinson's DiseaseDrug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)NovartisNULLCompleted30 Years80 YearsAll493Phase 3United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
1603EUCTR2005-001416-42-ES
(EUCTR)
28/07/200528/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIOA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson’s Disease Subjects. Estudio multicéntrico, doble ciego, de inicio randomizado, controlado con placebo, de grupos paralelos, para valorar Rasagilina como una terapia que modifica la enfermedad de Parkinson en pacientes con enfermedad de Parkinson en fase temprana - ADAGIO Parkinson's Disease
MedDRA version: 7.1;Level: PT;Classification code 10061536
Teva Pharmaceuticals Industries LtDNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Portugal;Hungary;Spain;Austria;Germany;Italy;United Kingdom
1604EUCTR2004-001485-41-GB
(EUCTR)
26/07/200521/06/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaser
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom;Spain
1605EUCTR2004-002844-93-AT
(EUCTR)
20/07/200515/06/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa TherapyA Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1606EUCTR2004-000835-27-ES
(EUCTR)
18/07/200523/05/2006A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON’S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST. Early idiopathic Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10013113
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals S.P.ANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
212Phase 3Spain;Italy
1607EUCTR2005-004290-19-AT
(EUCTR)
17/07/200506/12/2005A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's diseaseA double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's disease advanced-stage, idiopathic Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536
Product Name: Rotigotine Nasal Spray
Product Code: ND1421
INN or Proposed INN: Rotigotine hydrochloride
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
100Spain;Austria;Germany;United Kingdom
1608EUCTR2005-001416-42-IT
(EUCTR)
14/07/200521/06/2005A Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease SubjectsA Multicenter, Double-Blind, Randomized Start, Placebo-Controlled, Parallel-Group Study to Assess Rasagiline as a Disease Modifying Therapy in Early Parkinson's Disease Subjects Neuroprotective early treatment of Parkinson's disease subjects
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: NA
Product Code: NA
Other descriptive name: NA
Product Name: rasagiline
Product Code: TVP-1012
TEVANULLNot RecruitingFemale: yes
Male: yes
Portugal;Hungary;Germany;United Kingdom;Spain;Italy
1609EUCTR2005-000444-84-ES
(EUCTR)
12/07/200522/05/2006An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-OAn open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O Treatment- Associated Dyskinesia in Parkinson´s DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Finland;United Kingdom;Spain;Italy
1610EUCTR2004-002844-93-IT
(EUCTR)
06/07/200521/09/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. - Parkinson's Disease.
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: Istradefylline
Product Code: KW-6002
Other descriptive name: NA
KYOWA HAKKO UK LTDNULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1611NCT00125138
(ClinicalTrials.gov)
July 200527/7/2005Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's DiseaseSafety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's DiseaseParkinson's Disease;Psychotic DisordersDrug: Melperone HCl;Drug: PlaceboLundbeck LLCNULLCompletedN/AN/AAll90Phase 2United States;India;Italy
1612NCT00143026
(ClinicalTrials.gov)
July 200531/8/2005Study to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease. This Study is Not Recruiting in the United StatesStudy to Compare the Effect of Treatment With Carbidopa/Levodopa/Entacapone on the Quality of Life of Patients With Parkinson's Disease.Parkinson's DiseaseDrug: carbidopa, levodopa, entacaponeNovartisNULLCompleted30 YearsN/AAll184Phase 4Australia;Philippines;Taiwan;Thailand
1613EUCTR2005-000444-84-AT
(EUCTR)
22/06/200518/05/2005An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OAn open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
1614EUCTR2005-004314-33-AT
(EUCTR)
16/06/200505/12/2005A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor FluctuationsA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy, Safety and Tolerability of E2007 in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations Levodopa treated Parkinson's disease patients with motor fluctuations
MedDRA version: 8.1;Classification code 10061536
Product Name: MARS
Product Code: E2007
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Portugal;Hungary;Estonia;Spain;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
1615EUCTR2004-005234-39-SE
(EUCTR)
08/06/200502/05/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
240Finland;Germany;United Kingdom;Denmark;Ireland;Latvia;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1616NCT00139880
(ClinicalTrials.gov)
June 200529/8/2005A Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's DiseaseA Single Center, Randomized, Double-blind, Crossover Pilot Trial Comparing the Onset of Action of Parcopa™ With Sinemet® in Subjects With Stable Parkinson's DiseaseParkinson's DiseaseDrug: ParcopaUCB PharmaNULLCompleted40 YearsN/ABothPhase 3United States
1617NCT00642889
(ClinicalTrials.gov)
June 200521/3/2008Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist (12 Month Extension)A PHASE III, DOUBLE-BLIND, PLACEBO-CONTROLLED, 12-MONTH EXTENSION STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF A DOSE RANGE OF SAFINAMIDE OF 50-200 MG/DAY, AS ADD-ON THERAPY IN PATIENTS WITH EARLY IDIOPATHIC PARKINSON'S DISEASE TREATED WITH A STABLE DOSE OF A SINGLE DOPAMINE AGONIST.Parkinson's DiseaseDrug: Safinamide;Drug: PlaceboNewronNULLCompleted30 Years80 YearsBoth227Phase 3NULL
1618EUCTR2004-005234-39-GB
(EUCTR)
27/05/200522/03/2005Multicentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOPMulticentre, randomised, double-blind study to compare Stalevo® to levodopa/carbidopa in patients with Parkinson's disease experiencing symptoms of early wearing-off - SEWOP Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Orion Corporation, ORION PHARMA, FinlandNULLNot Recruiting Female: yes
Male: yes
240Phase 4Finland;Ireland;Lithuania;Denmark;Latvia;Germany;United Kingdom;Sweden
1619NCT03095092
(ClinicalTrials.gov)
May 23, 200523/3/2017Effect of Food on BIA 6-512 (Trans-resveratrol)The Effect of Food on the Pharmacokinetics of a Single 400 mg Oral Dose of BIA 6-512 (Trans-resveratrol) in Healthy SubjectsParkinson DiseaseDrug: BIA 6-512 400 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll24Phase 1Portugal
1620EUCTR2004-005034-39-GB
(EUCTR)
17/05/200520/04/2005Nicotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's diseaseNicotinamide,vitamin B3, metabolic pathways in patients with early idiopathic parkinson's disease Idiopathic Parkinson's diseaseTrade Name: Nicotinamide
Product Name: NICOTINAMIDE
INN or Proposed INN: Nicotinamide
Queen Elizabeth HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1621EUCTR2004-002641-12-GB
(EUCTR)
16/05/200530/06/2005A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's diseaseA multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Austria;Italy;United Kingdom
1622EUCTR2004-002608-13-GB
(EUCTR)
16/05/200519/04/2005Pragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s diseasePragmatic Randomised Control Trial of Quetiapine for psychosis in Parkinson’s Disease - Quetiapine for psychosis in Parkinson’s disease Parkinson's Disease with psychosisKing’s College London & King’s College HospitalNULLNot Recruiting Female: yes
Male: yes
60Phase 4United Kingdom
1623NCT03093389
(ClinicalTrials.gov)
May 11, 200522/3/2017Tolerability and Steady-state Pharmacokinetics of BIA 6-512A Double-blind, Randomised, Placebo-controlled, Rising Multiple-dose Study to Investigate the Tolerability and Steady-state Pharmacokinetics of BIA 6-512 (Trans-resveratrol) in Healthy VolunteersParkinson DiseaseDrug: BIA 6-512;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsAll40Phase 1Portugal
1624NCT00163085
(ClinicalTrials.gov)
May 20059/9/2005The Effects of an NR2B NMDA Antagonist, CP-101,606, in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Explore The Efficacy And Safety Of The NR2B NMDA Antagonist CP-101,606 In Patients With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: NR2B NMDA Antagonist CP-101,606 (traxoprodil)PfizerNULLCompleted30 Years80 YearsBoth12Phase 2United States
1625NCT00199433
(ClinicalTrials.gov)
May 200512/9/2005A Study of Istradefylline (KW-6002) as Monotherapy in Parkinson's Disease (PD) PatientsA Phase 2, Double-blind, Placebo-controlled, Randomized, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of 40mg/Day KW-6002 (Istradefylline) as Monotherapy in Subjects With Parkinson's DiseaseParkinson's Disease;Movement Disorder SyndromeDrug: Istradefylline (KW-6002)Kyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABoth160Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1626EUCTR2004-001485-41-ES
(EUCTR)
28/04/200530/01/2006A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s DiseaseA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: SINEMET
Product Name: carbodopa/levadopa
INN or Proposed INN: CARBODOPA LEVADOPA
Trade Name: SOLIGEN
Product Name: Cabergoline
INN or Proposed INN: CABERGOLINA
Trade Name: DaTSCAN
INN or Proposed INN: Ioflupane [123I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United Kingdom;Spain
1627EUCTR2004-002641-12-ES
(EUCTR)
25/04/200510/07/2006A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's diseaseA multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3bUnited Kingdom;Spain;Italy
1628EUCTR2004-001485-41-AT
(EUCTR)
20/04/200516/03/2005A single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/AA single-blinded assessment of the short-term effects of cabergoline vs. carbidopa/levodopa on SPECT dopamine transporter density in out-patient subjects with Parkinson’s Disease - N/A Approximately 120 recently diagnosed/early Parkinson’s disease subjects, who are untreated (see exclusionary criteria).Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: carbidopa/levodopa
Trade Name: Cabaseril
Product Name: Cabaseril
INN or Proposed INN: Cabergoline
Trade Name: DaTSCAN
Product Name: DatSCAN
INN or Proposed INN: Ioflupane [123 I]
Institute for Neurodegenerative DisordersNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Spain;Austria;United Kingdom
1629EUCTR2004-004139-74-DK
(EUCTR)
20/04/200522/03/2005Parkinson’s Disease: PET scan and evaluation of memantines pharmacological effect.(Parkinsons sygdom bedømt med PET skanning, herunder memantins farmakologiske effekt.) - N/AParkinson’s Disease: PET scan and evaluation of memantines pharmacological effect.(Parkinsons sygdom bedømt med PET skanning, herunder memantins farmakologiske effekt.) - N/A Parkinson's DiseaseTrade Name: Ebixa
Product Name: Ebixa
INN or Proposed INN: memantine
Neurologisk afdeling FNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Denmark
1630EUCTR2004-000817-20-IT
(EUCTR)
06/04/200513/04/2005A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa TherapyA 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (Istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: istradefylline
Product Code: KW-6002
Other descriptive name: NA
Trade Name: COMTAN 200* 60 CPR 200 MG
Product Name: NA
Product Code: NA
INN or Proposed INN: Entacapone
KYOWA HAKKO UK LTDNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1631EUCTR2004-002844-93-ES
(EUCTR)
01/04/200504/11/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1632NCT00199355
(ClinicalTrials.gov)
April 200512/9/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaPlacebo-Controlled , Double-Blind , Exploratory Study of KW-6002(Istradefylline) in the Treatment of Parkinson's Disease. [Adjunctive Therapy to Levodopa]Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Hakko Kirin Company, LimitedNULLCompleted30 YearsN/ABoth75Phase 2Japan
1633NCT00108667
(ClinicalTrials.gov)
April 200515/4/2005Talampanel to Treat Parkinson's DiseaseAMPA Receptor Antagonist Treatment of Parkinson's DiseaseParkinson DiseaseDrug: IV Levodopa;Drug: TalampanelNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth40Phase 2United States
1634EUCTR2004-001593-10-GB
(EUCTR)
21/03/200525/08/2005A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) - PADDY 1 Treatment-Associated Dyskinesia in Parkinson's DiseaseMerck KGaANULLNot Recruiting Female: yes
Male: yes
600Phase 3Italy;United Kingdom
1635EUCTR2004-002844-93-EE
(EUCTR)
08/03/200507/03/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1636EUCTR2004-002598-21-GB
(EUCTR)
02/03/200507/07/2005A phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's diseaseA phase 3b, open-label. multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease Idiopathic Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 3Austria;United Kingdom
1637NCT00203957
(ClinicalTrials.gov)
March 200513/9/2005Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on LevodopaA Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa TherapyParkinson's DiseaseDrug: IstradefyllineUniversity of ChicagoNULLCompleted18 YearsN/ABoth10Phase 3United States
1638NCT02834507
(ClinicalTrials.gov)
March 200513/7/2016Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease PatientsA Double-blind, Randomised, Placebo- and Active-controlled, Cross-over Study to Investigate the Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease PatientsParkinson's Disease (PD)Drug: Placebo;Drug: BIA 3-202;Drug: Comtan®;Drug: Sinemet®Bial - Portela C S.A.NULLCompleted30 Years75 YearsBoth19Phase 2NULL
1639EUCTR2004-002844-93-LT
(EUCTR)
08/02/200503/01/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
1640EUCTR2004-002650-59-GB
(EUCTR)
03/02/200530/06/2005A phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/aA phase 3b, open-label, multicentre, multinational trial to assess the tolerability of switching subjects from ropinerole, pramipexole or cabergoline to the rotigotine transdermal system and its effect on symptoms with idiopathic Parkinson's disease - n/a Idiopathic Parkinson's diseaseProduct Name: rotigotine
Product Code: SPM 962
INN or Proposed INN: rotigotine
SCHWARZ BIOSCIENCESNULLNot RecruitingFemale: yes
Male: yes
130Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1641EUCTR2004-000817-20-AT
(EUCTR)
02/02/200529/12/2004A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Trade Name: Comtess
Product Name: Comtess
INN or Proposed INN: Entacapone
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Lithuania;Austria;Latvia;Italy
1642EUCTR2004-001594-25-AT
(EUCTR)
02/02/200529/12/2004A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Austria
1643EUCTR2004-002844-93-GB
(EUCTR)
01/02/200523/02/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain
1644NCT00505687
(ClinicalTrials.gov)
February 200520/7/2007An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseA Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll186Phase 3United States;Austria;Germany;Israel;Italy;South Africa;Spain;United Kingdom
1645EUCTR2004-002844-93-LV
(EUCTR)
28/01/200531/01/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1646EUCTR2004-002641-12-AT
(EUCTR)
21/01/200517/12/2004A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's diseaseA multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3bSpain;Austria;Italy;United Kingdom
1647NCT00219284
(ClinicalTrials.gov)
January 200530/6/2005Effects of Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's DiseaseA Prospective, Multi-center, Randomized, Open-label Study With Blinded Raters to Evaluate the Effects of Immediate Versus Delayed Switch to Carbidopa/Levodopa/Entacapone on Motor Function and Quality of Life in Patients With Parkinson's Disease With End-of-dose Wearing OffParkinson's Disease With End of Dose Wearing OffDrug: Carbidopa/levodopa/entacaponeNovartis PharmaceuticalsNULLCompleted30 Years85 YearsAll359Phase 4United States;Puerto Rico
1648NCT00144300
(ClinicalTrials.gov)
January 20052/9/2005Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) PatientsA Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease PatientsParkinson DiseaseDrug: Mirapex;Drug: RequipBoehringer IngelheimNULLCompleted30 YearsN/AAll246Phase 4United States
1649NCT01634243
(ClinicalTrials.gov)
January 200527/6/2012A Dose-ranging Study for SPM 962 in Parkinson's Disease PatientsA Open-label Dose-ranging Study for SPM 962 in Parkinson's Disease PatientsParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompleted30 Years79 YearsAll64Phase 2Japan
1650NCT00103597
(ClinicalTrials.gov)
January 200511/2/2005Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System AtrophyEfficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System AtrophyParkinson's Disease;Multiple System Atrophy;Orthostatic HypotensionDrug: Fludrocortisone;Drug: Domperidone;Behavioral: Conservative Measures for Orthostatic HypotensionRoyal Brisbane and Women's HospitalNULLCompleted40 Years95 YearsBoth50Phase 1Australia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1651EUCTR2004-001594-25-FI
(EUCTR)
30/12/200426/10/2004A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY 2 Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain
1652EUCTR2004-002598-21-AT
(EUCTR)
22/12/200417/11/2004A phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's diseaseA phase 3b, open-label, multicenter, multinational trial to evaluate the effects of rotigotine transdermal patch on early morning motor impairment and sleep disorders in patients with idiopathic Parkinson's disease Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
50Phase 3bAustria;United Kingdom
1653EUCTR2004-002609-66-IT
(EUCTR)
21/12/200403/03/2006A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s diseaseA phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease Idiopathic Parkinson Disease in early stage
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: rotigotine
Product Code: SPM 926
Trade Name: REQUIP 21 CPR 0,25 MG
INN or Proposed INN: Ropinirole
Product Name: rotigotine
Product Code: SPM 962
Trade Name: REQUIP 21 CPR 0,5 MG
INN or Proposed INN: Ropinirole
Product Name: rotigotine
Product Code: SPM 962
Product Name: rotigotine
Product Code: SPM 962
Trade Name: REQUIP 21 CPR 1 MG
INN or Proposed INN: Ropinirole
Trade Name: REQUIP 21 CPR 2 MG
INN or Proposed INN: Ropinirole
SCHWARZ PHARMANULLNot RecruitingFemale: yes
Male: yes
60Phase 3Germany;Italy
1654EUCTR2004-000817-20-ES
(EUCTR)
10/12/200404/05/2005A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Trade Name: Comtan
Product Name: Comtess
INN or Proposed INN: Entacapone
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1655EUCTR2004-002609-66-DE
(EUCTR)
06/12/200422/04/2005A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's diseaseA phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM962
INN or Proposed INN: Rotigotine
Trade Name: Requip
Product Name: Requip
INN or Proposed INN: Ropinirole
Trade Name: Requip
Product Name: Requip
INN or Proposed INN: Ropinirole
Trade Name: Requip
Product Name: Requip
INN or Proposed INN: Ropinirole
Trade Name: Requip
Product Name: Requip
INN or Proposed INN: Ropinirole
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 3Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1656EUCTR2004-000835-27-IT
(EUCTR)
03/12/200421/07/2005A phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonistA phase III, double-blind, placebo-controlled, 12-month extension study to investigate the efficacy and safety of a dose range of safinamide of 50-200 mg/day, as add-on therapy in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: Safinamide
Product Code: NW-1015
NEWRON PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain;Italy
1657EUCTR2004-001593-10-IT
(EUCTR)
02/12/200403/01/2005A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1)A double-blind, placebo-controlled, multicenter, multinational Phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia (PADDY 1) Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Name: Sarizotan hydrochloride
Product Code: EMD 128130
INN or Proposed INN: Sarizotan hydrochloride
MERCK S.P.A.NULLNot RecruitingFemale: yes
Male: yes
Phase 3United Kingdom;Italy
1658EUCTR2004-000833-12-IT
(EUCTR)
02/12/200415/03/2005A Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonistA Phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic Parkinson's Disease treated with a stable dose of a single dopamine agonist Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Monoamine oxidase B inhibitors
NEWRON PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
Phase 3Spain;Italy
1659EUCTR2004-000833-12-ES
(EUCTR)
02/12/200423/11/2004A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist.A phase III, double-blind, placebo-controlled study to determine the efficacy and safety of a low (50-100 mg/day) and high (150-200 mg/day) dose range of safinamide, as add-on therapy, in patients with early idiopathic parkinson’s disease treated with a stable dose of a single dopamine agonist. Early idiopathic Parkinson’s disease
MedDRA version: 7.0;Level: LLT;Classification code 10013113
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Newron Pharmaceuticals S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3Spain;Italy
1660EUCTR2004-000185-12-IT
(EUCTR)
02/12/200427/06/2005A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's diseaseA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo in patients with Parkinson's disease Parkinson's Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Trade Name: Stalevo
Product Name: NA
Product Code: NA
INN or Proposed INN: carbidopa
INN or Proposed INN: levodopa
INN or Proposed INN: entecapone
Trade Name: Sinemet
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA (DC.IT) (FU)
INN or Proposed INN: CARBIDOPA (FU)
Trade Name: Stalevo
Product Name: NA
Product Code: NA
INN or Proposed INN: carbidopa
INN or Proposed INN: levodopa
INN or Proposed INN: entecapone
Trade Name: Sinemet
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA (DC.IT) (FU)
INN or Proposed INN: CARBIDOPA (FU)
Trade Name: Sinemet
Product Name: NA
Product Code: NA
INN or Proposed INN: LEVODOPA (DC.IT) (FU)
INN or Proposed INN: CARBIDOPA (FU)
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1661NCT00643045
(ClinicalTrials.gov)
December 200421/3/2008Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine AgonistA Phase III, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of a Low (50 100 mg/Day) and High (150 200 mg/Day) Dose Range of Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine AgonistIdiopathic Parkinson's DiseaseDrug: Safinamide;Drug: PlaceboNewronNULLCompleted30 Years80 YearsBoth269Phase 3NULL
1662NCT00243945
(ClinicalTrials.gov)
December 200424/10/2005A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's DiseaseA Phase 3b, Open-Label, Multicenter, Multinational Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders in Patients With Idiopathic Parkinson's DiseaseIDIOPATHIC PARKINSON'S DISEASEDrug: RotigotineUCB PharmaNULLCompleted18 YearsN/ABoth58Phase 3Germany
1663NCT00242008
(ClinicalTrials.gov)
December 200418/10/2005A Trial To Assess Switching From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System In Idiopathic Parkinson's DiseaseA Phase 3b, Open-Label, Multicenter, Multinational Trial To Assess The Tolerability Of Switching Subjects From Ropinirole, Pramipexole Or Cabergoline To The Rotigotine Transdermal System And Its Effect On Symptoms In Subjects With Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 YearsN/ABothPhase 3United States
1664EUCTR2004-000185-12-AT
(EUCTR)
25/11/200421/10/2004A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name:
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
740Finland;Austria;Italy;United Kingdom;Sweden
1665EUCTR2004-001594-25-ES
(EUCTR)
24/11/200402/11/2004A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2A double-blind, placebo controlled, multicenter, multinational, phase III study to evaluate the safety and efficacy of Sarizotan HCl 1 mg b.i.d in patients with Parkinson' s disease suffering from treatment-associated dyskinesia. - PADDY-2 Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Name: Sarizotan
Product Code: EMD 128130
INN or Proposed INN: Sarizotan Hydrochloride
MERCK KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Finland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1666NCT01518309
(ClinicalTrials.gov)
November 17, 200416/12/2008An Open-label Safety Study of Pimavanserin in Parkinson's Disease PatientsAn Open-Label Safety Study of Pimavanserin in Parkinson's Disease PatientsParkinson's Disease PsychosisDrug: pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompletedN/AN/AAll39Phase 2United States
1667EUCTR2004-000185-12-SE
(EUCTR)
11/11/200403/09/2004A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
Product Name:
Orion Corporation, ORION PHARMA, 02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
1668EUCTR2004-000817-20-GB
(EUCTR)
08/11/200411/02/2005A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Trade Name: Comtess
Product Name: Comtess
INN or Proposed INN: Entacapone
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Phase 3Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
1669NCT03091868
(ClinicalTrials.gov)
November 3, 200421/3/2017Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa PharmacokineticsA Double-blind, Randomised, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability and Pharmacokinetics of Rising Single-doses of BIA 6-512 and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Carbidopa 100/25 mg or With a Single-dose of Levodopa/Carbidopa 100/25 mg Plus a Single-dose of Entacapone 200 mgParkinson DiseaseDrug: Placebo oral capsule;Drug: Sinemet® 100/25;Drug: Comtan®;Drug: BIA 6-512 25 mg;Drug: BIA 6-512 100 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll80Phase 1Portugal
1670NCT00199394
(ClinicalTrials.gov)
November 200412/9/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's DiseaseA 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/Day KW-6002 (Istradefylline) and That of Entacapone Versus Placebo as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Hakko Kirin UK, Ltd.NULLCompleted30 YearsN/ABoth405Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1671NCT00243971
(ClinicalTrials.gov)
November 200424/10/2005A Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's DiseaseA Phase 3, Randomized, Open-Label, Two-Arm, Parallel-Group, Multicenter, Multinational Trial to Compare the Efficacy of Rotigotine Transdermal Patch to That of Ropinirole on Early Morning Motor Impairment and Sleep Disorders in Subjects With Early-Stage, Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: SPM 962UCB PharmaNULLCompleted18 YearsN/ABothPhase 3Germany
1672NCT01634360
(ClinicalTrials.gov)
November 20043/7/2012Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor FluctuationsA 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period DyskinesiasParkinson's DiseaseDrug: PerampanelEisai Inc.NULLTerminatedN/AN/AAll185Phase 2NULL
1673EUCTR2004-000361-35-IT
(EUCTR)
22/10/200423/05/2005A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS.A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. Parkinson's disease.
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: NA
Product Code: E2007
Other descriptive name: NA
EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
Czech Republic;Italy
1674EUCTR2004-000817-20-LV
(EUCTR)
22/10/200427/10/2004A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Trade Name: Comtess
Product Name: Comtess
INN or Proposed INN: Entacapone
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1675EUCTR2004-000361-35-CZ
(EUCTR)
18/10/200422/10/2004A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS.A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. Parkinson's DiseaseProduct Name: MARS
Product Code: E2007
Other descriptive name: MARS
Other descriptive name: MARS
Other descriptive name: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
225Czech Republic;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1676EUCTR2004-000148-26-ES
(EUCTR)
13/10/200416/09/2004A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/AA multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Schwarz BioSciences Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1677EUCTR2004-000148-26-CZ
(EUCTR)
12/10/200411/10/2004A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/AA multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Schwarz BioSciences Inc.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1678NCT00105508
(ClinicalTrials.gov)
September 30, 200415/3/2005Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated DyskinesiaA Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated DyskinesiaParkinson's Disease;DyskinesiaDrug: Sarizotan;Drug: PlaceboEMD SeronoNULLCompleted30 YearsN/AAll506Phase 3United States
1679EUCTR2004-000148-26-SE
(EUCTR)
29/09/200405/07/2004A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/AA multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Schwarz BioSciences Inc.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1680EUCTR2004-000185-12-FI
(EUCTR)
21/09/200423/07/2004A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PDA long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson’s disease requiring initiation of levodopa therapy. - STRIDE-PD Parkinson's disease
MedDRA version: 7.0;Level: LLT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Orion Corporation, ORION PHARMANULLNot RecruitingFemale: yes
Male: yes
740Finland;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1681EUCTR2004-000817-20-LT
(EUCTR)
16/09/200407/01/2005A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy.A 16-week, Double-Blind, Placebo-Controlled, Randomised, Parallel-Group, Multicentre, International Study to Evaluate the Efficacy and Safety of 40 mg/day KW-6002 (istradefylline) and that of Entacapone versus Placebo as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Trade Name: Comtess
Product Name: Comtess
INN or Proposed INN: Entacapone
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
405Spain;Italy;Latvia;Lithuania
1682EUCTR2004-003355-39-AT
(EUCTR)
14/09/200408/10/2004A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia.A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. Dementia associated with Parkinson's diseaseTrade Name: Aricept 5 mg-Filmtabletten
Product Name: Aricept 5mg-Filmtabletten
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
468Austria
1683NCT00105521
(ClinicalTrials.gov)
September 200415/3/2005Sarizotan HCl in Patients With Parkinson's Disease Suffering From Treatment-Associated DyskinesiaA Double-blind, Placebo-controlled, Multicenter, Multinational Phase III Study to Evaluate the Safety and Efficacy of Sarizotan HCl 1 mg b.i.d. in Patients With Parkinson's Disease Suffering From Treatment-associated DyskinesiaParkinson's Disease;DyskinesiaDrug: Sarizotan HC1EMD SeronoNULLCompleted30 YearsN/AAll594Phase 3United States
1684NCT00296959
(ClinicalTrials.gov)
September 200423/2/2006Topiramate as a Treatment for Levodopa-Induced Dyskinesia in Parkinson's DiseaseAnti-Dyskinetic Properties of Topiramate: A Double-Blind, Placebo-Controlled Trial in Patients With Parkinson's Disease and Levodopa-Induced DyskinesiasParkinson's DiseaseDrug: topiramate (drug)University Health Network, TorontoNULLTerminated30 Years75 YearsBoth20Phase 2Canada
1685NCT00641186
(ClinicalTrials.gov)
September 200418/3/2008Trial of Xyrem for Excessive Daytime Sleepiness and Sleep Disturbance in Parkinson's Disease (PD)A Phase II, Eight Week, Multi-Center, Open Label Trial of Xyrem(R) (Sodium Oxybate) for Excessive Daytime Sleepiness and Nocturnal Sleep Disturbance in Patients With Mild to Moderate Parkinson's DiseaseParkinson DiseaseDrug: sodium oxybateBaylor College of MedicineJazz PharmaceuticalsCompleted30 Years75 YearsBoth30Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1686NCT00089622
(ClinicalTrials.gov)
August 4, 20046/8/2004Lisuride Patch to Treat Parkinson's DiseaseTranscutaneous Lisuride Therapy of Parkinson's DiseaseParkinson DiseaseDrug: Intravenous Levodopa;Drug: Lisuride Transdermal SystemNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted40 Years80 YearsAll40Phase 2United States
1687NCT00501969
(ClinicalTrials.gov)
August 200416/7/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advanced-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP515 (NCT00244387) Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease Who Are Not Well Controlled on L-DopaAdvanced Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll395Phase 3Australia;Austria;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;New Zealand;Norway;Poland;South Africa;Spain;Sweden;United Kingdom
1688EUCTR2004-000148-26-FI
(EUCTR)
30/07/200428/06/2004A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/AA multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A Parkinson's DiseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol
Schwarz BioSciences Inc.NULLNot RecruitingFemale: yes
Male: yes
360Phase 3Czech Republic;Hungary;Finland;Spain;Italy;Sweden
1689NCT00199420
(ClinicalTrials.gov)
July 200412/9/2005A Study of Istradefylline (KW-6002) in Treating Patients With Parkinson's Disease on LevodopaA 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of 10, 20 and 40 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABoth580Phase 3United States
1690NCT00174239
(ClinicalTrials.gov)
July 20049/9/2005Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.Parkinson DiseaseDrug: cabergoline;Drug: controlled-release levodopa / carbidopaPfizerNULLTerminated18 Years80 YearsBoth220Phase 4Australia;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1691NCT00086294
(ClinicalTrials.gov)
June 25, 200429/6/2004ACP-103 to Treat Parkinson's Disease5HT2A/C Serotonin Blockade in Parkinson's DiseaseParkinson's Disease;DyskinesiasDrug: Intravenous Levodopa;Drug: ACP-103National Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted30 Years80 YearsAll40Phase 2United States
1692EUCTR2004-000148-26-IT
(EUCTR)
14/06/200426/07/2007A multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopaA multi-center, multinational, phase 3, open-label extension trial to assess the safety of long term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinsons disease who are not well controlled on levodopa Advanced stage Parkinson's DiseaseINN or Proposed INN: rotigotine SCHWARZ PHARMANULLNot RecruitingFemale: yes
Male: yes
360Phase 3Hungary;Finland;Czech Republic;Spain;Italy;Sweden
1693NCT00203138
(ClinicalTrials.gov)
June 200413/9/2005Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's DiseaseA Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: rasagiline mesylateTeva Pharmaceutical IndustriesNULLCompleted35 YearsN/ABoth306Phase 3United States
1694NCT00199407
(ClinicalTrials.gov)
June 200412/9/2005A Study of Istradefylline (KW-6002) for the Treatment of Parkinson's Disease in Patients Taking LevodopaA 12-week, Double Blind, Placebo-controlled, Randomized, Parallel Group, Multicenter, Fixed Dose Study to Evaluate the Efficacy and Safety of a 20 mg/d Oral Dose of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa Therapy.Parkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABoth230Phase 3United States
1695NCT03091543
(ClinicalTrials.gov)
May 4, 200421/3/2017Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa PharmacokineticsA Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mgParkinson DiseaseDrug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg doseBial - Portela C S.A.NULLCompleted18 Years45 YearsAll20Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1696NCT01172379
(ClinicalTrials.gov)
May 200426/7/2010A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period DyskinesiasA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of the Safety, Tolerability and Efficacy of E2007 in Parkinson's Disease Patients With Wearing Off Motor Fluctuations and On Period DyskinesiasParkinson's DiseaseDrug: E2007;Other: Placebo ComparatorEisai LimitedNULLCompleted30 Years75 YearsBoth2Phase 2Czech Republic;France;Germany;Italy;Serbia;Spain
1697NCT00087542
(ClinicalTrials.gov)
March 20049/7/2004Treatment of Hallucinosis/Psychosis in Parkinson's Disease by an Investigational DrugHallucinations;Psychoses;Parkinson's DiseaseDrug: ACP-103ACADIA Pharmaceuticals Inc.NULLCompletedN/AN/ABoth60Phase 2United States
1698NCT00200447
(ClinicalTrials.gov)
March 200412/9/2005An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)Assessment of Carbidopa/l-Dopa and Carbidopa/l Dopa/Entacapone on Synaptic Dopamine in Parkinson's Patients: An Open-Label Feasibility/Pilot Study With [123I]-IBZM SPECT (DOPA-SYN)Parkinson's DiseaseDrug: carbidopa/l-dopa;Drug: carbidopa/l-dopa/entacapone;Drug: Stalevo;Procedure: [123I]-IBZM imagingMolecular NeuroImagingNULLCompleted30 YearsN/ABoth3Phase 2NULL
1699NCT00244387
(ClinicalTrials.gov)
March 200424/10/2005Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on LevodopaA Multi-centre, Multi-national, Phase 3, Randomized, Double-blind, Double-dummy, 3- Arm Parallel Group, Placebo- and Pramipexole- Controlled Trial of the Efficacy and Safety of Rotigotine Patch in Subjects With Advanced Stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled on LevodopaParkinson Disease, IdiopathicDrug: SPM 962UCB PharmaNULLCompleted30 YearsN/ABoth506Phase 3Germany
1700NCT02248181
(ClinicalTrials.gov)
February 200422/9/2014Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's DiseasePost Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: PramipexoleBoehringer IngelheimNULLCompletedN/AN/ABoth442N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1701NCT00673088
(ClinicalTrials.gov)
February 20045/5/2008A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted ConditionsA Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Und Fasted ConditionsParkinson's Disease;Restless Leg SyndromeDrug: Ropinirole HydrochlorideRoxane LaboratoriesNULLCompleted18 Years45 YearsAll30N/ANULL
1702NCT00674310
(ClinicalTrials.gov)
February 20045/5/2008A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed ConditionsA Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed ConditionsParkinson's Disease;Restless Leg SyndromeDrug: Ropinirole HydrochlorideRoxane LaboratoriesNULLCompleted18 Years45 YearsAll29N/ANULL
1703NCT00632736
(ClinicalTrials.gov)
February 20044/3/2008An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s DiseaseAn Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169Parkinson Disease;Parkinson's DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll419Phase 3United States;Belgium;Czech Republic;France;Hungary;Italy;Poland;Spain;United Kingdom;Germany;Philippines
1704NCT00076674
(ClinicalTrials.gov)
January 200428/1/2004Levetiracetam Treatment of L-dopa Induced DyskinesiasLevetiracetam Treatment of L-dopa Induced DyskinesiasDyskinesias;Parkinson DiseaseDrug: Intravenous LevodopaNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth40Phase 2United States
1705NCT00139867
(ClinicalTrials.gov)
January 200429/8/2005A Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's DiseaseA Multicenter, Open-label Trial to Assess Subject Preference of PARCOPA, Carbidopa/Levodopa Orally Disintegrating Tablets, Compared to Conventional Carbidopa/Levodopa Tablets in Subjects With Stable Parkinson's DiseaseParkinson's DiseaseDrug: PARCOPAUCB PharmaNULLCompleted18 YearsN/ABothPhase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1706NCT00220272
(ClinicalTrials.gov)
January 200416/9/2005Study of the Effect of SR57667B on 18F-Dopa PET Imaging in Patients With Parkinson's DiseaseA Phase II, Randomized, Multicenter, Multinational, Double-Blind, Placebo-Controlled, Study of the Effect of SR57667B on Dopaminergic Nigro-Striatal Function Assessed by 18F-Dopa PET Imaging in Outpatients With Early Parkinson's DiseaseParkinson DiseaseDrug: SR57667BSanofiNULLCompleted35 YearsN/ABoth183Phase 2Canada;Finland;France;Netherlands;Spain;Switzerland;United Kingdom
1707NCT02231905
(ClinicalTrials.gov)
January 20043/9/2014Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's DiseaseOpen Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to PramipexoleParkinson DiseaseDrug: BI-Sifrol®Boehringer IngelheimNULLCompleted20 YearsN/ABoth29Phase 4NULL
1708NCT00212693
(ClinicalTrials.gov)
January 200413/9/2005Controlled Study of ONO-2506PO in Patients With Parkinson's Disease in JapanControlled Study of ONO-2506PO in Patients With Parkinson's Disease in JapanParkinson's DiseaseDrug: ONO-2506POOno Pharmaceutical Co. LtdNULLCompleted20 Years79 YearsBoth165Phase 2NULL
1709NCT00363727
(ClinicalTrials.gov)
December 20037/8/2006Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson'sA Two Year Phase IIIb Randomised, Multicenter, Double-blind, SINEMET Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled Release Ropinirole add-on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects.Parkinson's Disease;Parkinson Disease;DyskinesiasDrug: ropinirole controlled-release (REQUIP CR) for RLSGlaxoSmithKlineNULLCompleted30 Years70 YearsAll209Phase 3United States
1710NCT01941732
(ClinicalTrials.gov)
November 200310/9/2013Motor Response to Sildenafil in PDMotor Response to Acute Challenge to Sildenafil in Parkinsons DiseaseParkinsons Disease;Erectile DysfunctionDrug: SildenafilBispebjerg HospitalNULLCompleted18 Years80 YearsMale8Phase 4Denmark
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1711NCT00615472
(ClinicalTrials.gov)
October 20039/1/2008Intravenous Versus Inhalational Anesthesia in Parkinson's DiseaseIntravenous General Anesthesia Versus Inhalational General Anesthesia in Parkinson's DiseaseParkinson's DiseaseDrug: Isoflurane;Drug: Remifentanil;Drug: PropofolColumbia UniversityNULLTerminated18 YearsN/AAll58N/AUnited States
1712NCT00215904
(ClinicalTrials.gov)
August 200318/9/2005D-serine Adjuvant Treatment for Parkinson's DiseaseD-serine Adjuvant Treatment for Parkinson's DiseaseParkinson's DiseaseDrug: D-serine (~2g/day)Herzog HospitalNULLCompleted30 Years75 YearsBoth13Phase 4Israel
1713NCT00228150
(ClinicalTrials.gov)
July 200326/9/2005Study of the Effect of SR57667B on the Progression of Symptoms in Patients With Parkinson's DiseaseA Phase II, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Outpatients With Early Parkinson's DiseaseParkinson DiseaseDrug: SR57667BSanofiNULLCompleted35 YearsN/ABoth564Phase 2Austria;Canada;Denmark;France;Germany;Morocco;Netherlands;Portugal;South Africa;Spain;Sweden;Tunisia;United Kingdom
1714NCT00160576
(ClinicalTrials.gov)
July 20038/9/2005Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome DyskinesiasA Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: LevetiracetamUCB PharmaNULLCompleted30 YearsN/ABoth30Phase 2NULL
1715NCT00240409
(ClinicalTrials.gov)
July 200314/10/2005Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's DiseaseA Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease.Parkinson DiseaseDrug: Pramipexole;Drug: BromocriptineBoehringer IngelheimNULLCompleted30 Years80 YearsBoth208Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1716NCT00381472
(ClinicalTrials.gov)
June 200326/9/2006Investigational Parkinson's Disease In Patients Not Well Controlled On L-dopaA Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole CR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-dopaParkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted30 YearsN/AAll393Phase 3United States;Belgium;Czech Republic;France;Germany;Hungary;Italy;Poland;Spain
1717NCT00148486
(ClinicalTrials.gov)
June 20037/9/2005A Fourteen-Week Placebo-Controlled Dose-Response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)A Fourteen-week Placebo-controlled Dose-response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)Parkinson DiseaseDrug: NS 2330Boehringer IngelheimNULLCompleted40 Years80 YearsBoth261Phase 2United States;Canada
1718NCT00058838
(ClinicalTrials.gov)
April 200314/4/2003Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's DiseaseA Phase III, Double-Blind, Placebo-Controlled, Fixed-Dose Response Study Comparing the Efficacy and Safety of Sumanirole Versus Placebo in Patients With Early Parkinson's Disease.Parkinson DiseaseDrug: sumanirolePfizerNULLCompleted30 YearsN/ABoth854Phase 3United States;Argentina;Australia;Austria;Belgium;Colombia;France;Germany;Greece;Italy;Mexico;Peru;Puerto Rico;Spain
1719NCT00058721
(ClinicalTrials.gov)
April 200311/4/2003Single Photon Emission Computed Tomography to Study Receptors in Parkinson's DiseaseSPECT Evaluation of Nicotinic Cholinergic Receptors in Parkinson's DiseaseParkinson DiseaseDrug: I-123-5-IA85380National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth60N/AUnited States
1720NCT01327859
(ClinicalTrials.gov)
March 200330/3/2011Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With DementiaA 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With DementiaParkinson's Disease;DementiaDrug: Prior Donepezil 5mg;Drug: Prior Donzepezil 10mg;Drug: Prior PlaceboEisai Inc.NULLCompleted40 YearsN/ABoth357Phase 3United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1721NCT00148512
(ClinicalTrials.gov)
March 20037/9/2005A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor FluctuationsA Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)Parkinson DiseaseDrug: 1. Tesofensine (NS 2330)Boehringer IngelheimNULLCompleted42 Years80 YearsBoth254Phase 2Austria;France;Germany;Netherlands;Spain;United Kingdom;El Salvador
1722NCT00115427
(ClinicalTrials.gov)
March 200322/6/2005Study of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's DiseaseMulticenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Liatermin (r-metHuGDNF) Administered by Bilateral Intraputaminal (IPu) Infusion to Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: Liatermin (r-metHuGDNF)AmgenNULLCompleted35 Years70 YearsBothPhase 1United States
1723NCT00056524
(ClinicalTrials.gov)
February 200315/3/2003Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.Alzheimer's Disease;Stroke;Parkinson's Disease;Traumatic Brain InjuryDrug: AVP-923Avanir PharmaceuticalsNULLCompleted18 Years80 YearsBoth600Phase 3United States
1724NCT00237263
(ClinicalTrials.gov)
February 20037/10/2005An Extension Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-off. This Study is Not Recruiting in the United StatesAn Extension Study to Phase IIb Dose-finding Study of Entacapone in Patients With Parkinson's Disease With End-of-dose Wearing-offParkinson's DiseaseDrug: EntacaponeNovartisNULLCompleted20 YearsN/AAll285Phase 2United States
1725NCT00451815
(ClinicalTrials.gov)
January 200331/1/2006BIIB014 Phase 2a MonotherapyA Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of Multiple Oral Dose Administration of BIIB014 in Subjects With Early Parkinson’s DiseaseParkinson's DiseaseDrug: active drug (BIIB014) at 10, 30, 100, or 300 mg once daily.;Drug: placeboBiogen IdecNULLWithdrawn30 Years78 YearsBothPhase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1726NCT02248207
(ClinicalTrials.gov)
January 200322/9/2014Tolerability of Sifrol® in Ambulatory Patients Suffering From Parkinson's DiseaseManagement of Parkinson's Disease Patients at Their First Visits in a Neurological PracticeParkinson DiseaseDrug: PramipexoleBoehringer IngelheimNULLCompletedN/AN/ABoth1293N/ANULL
1727NCT00247247
(ClinicalTrials.gov)
December 200231/10/2005Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing- Off.Efficacy and Tolerability of Comtess® Versus Cabaseril® as Add-on to Levodopa in the Treatment of Parkinsonian Patients Suffering From Wearing-Off PhenomenonParkinson's DiseaseDrug: Comtess®Orion Corporation, Orion PharmaNULLCompleted60 YearsN/ABoth300Phase 4Germany
1728NCT00209508
(ClinicalTrials.gov)
November 200213/9/20052 Year Study to Evaluate the Effects of GPI 1485 on [123I]b-CIT/SPECTScanning and Clinical Efficacy in Patients With PDRandomized, Double-Blind, Placebo-Controlled, Parallel-Group, 2-Year Study To Evaluate The Effects Of GPI 1485 On [123I]b-CIT/SPECT Scanning And Clinical Efficacy In Symptomatic PD Patients Receiving Dopamine Agonist Therapy.Parkinson's DiseaseDrug: GPI 1485Eisai Inc.Symphony Neuro Development CompanyCompleted40 Years80 YearsBoth200Phase 2NULL
1729NCT00955045
(ClinicalTrials.gov)
August 20024/8/2009A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyA Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyParkinson's DiseaseDrug: istradefyllineKyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABothPhase 2;Phase 3United States
1730NCT00165815
(ClinicalTrials.gov)
August 200213/9/2005The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With DementiaDementia With Parkinson's DiseaseDrug: ARICEPTEisai LimitedNULLCompleted40 YearsN/ABothPhase 3Germany;Ireland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1731NCT00599196
(ClinicalTrials.gov)
August 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's DiseaseEarly Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted30 YearsN/AAll381Phase 3Australia;Austria;Belgium;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;South Africa;Spain;Sweden;Switzerland;United Kingdom
1732NCT00594386
(ClinicalTrials.gov)
August 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll258Phase 3United States;Canada
1733NCT00314288
(ClinicalTrials.gov)
July 200212/4/2006Sarizotan in Parkinson Patients With L-dopa-induced DyskinesiaA Multicenter, Multinational, Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-finding Study to Investigate the Anti-dyskinetic Efficacy and Safety of Sarizotan in Parkinson Patients With L-dopa-induced DyskinesiaParkinson's Disease;DyskinesiaDrug: Sarizotan HClEMD SeronoNULLCompleted30 YearsN/AAll360Phase 2United States;Belgium;Bulgaria;Canada;France;Germany;Hungary;Portugal;Romania;South Africa;United Kingdom
1734NCT00043849
(ClinicalTrials.gov)
July 200214/8/2002Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)Dementia;Parkinson DiseaseDrug: QuetiapineNational Institute on Aging (NIA)NULLCompleted50 YearsN/ABoth60Phase 4United States
1735NCT00040209
(ClinicalTrials.gov)
June 200221/6/2002JP-1730 to Treat Parkinson's DiseaseAlpha-2 Adrenergic Antagonist Treatment of Parkinson's DiseaseParkinson DiseaseDrug: JP 1730;Drug: IV Levodopa;Drug: IV ApomorphineNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth30Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1736NCT00594165
(ClinicalTrials.gov)
June 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.Early-Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll217Phase 3United States;Canada
1737NCT00650104
(ClinicalTrials.gov)
May 200227/3/2008Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164Parkinson DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll76Phase 3United States;Belgium;France;Netherlands;Norway
1738NCT00203164
(ClinicalTrials.gov)
May 200213/9/2005Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease PatientsA Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa TherapyParkinson's DiseaseDrug: rasagiline mesylateTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth254Phase 3United States
1739NCT01044992
(ClinicalTrials.gov)
May 20026/1/2010Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) StudyMotor Activation in Patients With Multi Systemic Atrophy and Comparison With Parkinson Disease and Dopaminergic ChallengeMultisystemic AtrophyRadiation: H215O PET;Drug: LevodopaUniversity Hospital, ToulouseNULLCompleted40 Years75 YearsBoth38N/AFrance
1740NCT00456586
(ClinicalTrials.gov)
April 20023/4/200712-Week, Double-Blind, Placebo-Controlled, Randomized Study of the Efficacy of 40 mg/Day KW-6002 in Parkinson's Disease Patients on Levodopa/CarbidopaA 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of 40 mg/Day KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyParkinson's DiseaseDrug: KW-6002 (istradefylline)Kyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABoth180Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1741NCT00032812
(ClinicalTrials.gov)
March 20023/4/2002The Role of Dopamine in Motor Learning in Healthy Subjects and Patients With Parkinson's DiseaseMotor Memory: Study of the Role of Dopamine in Healthy Subjects and Patients With Parkinson's Disease Using PET and EEGParkinson Disease;HealthyDrug: RacloprideNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth64N/AUnited States
1742NCT02248168
(ClinicalTrials.gov)
March 200222/9/2014Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's DiseaseMirapex PMS Study Final ReportParkinson DiseaseDrug: PramipexoleBoehringer IngelheimNULLCompletedN/AN/ABoth1449N/ANULL
1743NCT00456794
(ClinicalTrials.gov)
March 20023/4/200712-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/CarbodopaA 12-Week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study of the Efficacy of Doses of 20 and 60 mg/Day Istradefylline as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/CarbidopaParkinson's DiseaseDrug: Istradefylline (KW-6002)Kyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABoth325Phase 2United States
1744NCT00030979
(ClinicalTrials.gov)
February 200215/2/2002Donepezil to Treat Dementia in Parkinson's DiseaseDonepezil for Dementia in Parkinson's Disease: A Randomized, Double Blinded Placebo Controlled Crossover TrialParkinson DiseaseDrug: DonepezilNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth28Phase 4United States
1745NCT02231255
(ClinicalTrials.gov)
February 20022/9/2014Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's DiseaseSwitch Post Marketing Surveillance Study in Patients With Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: Sifrol®Boehringer IngelheimNULLCompletedN/AN/ABoth1216N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1746NCT02162979
(ClinicalTrials.gov)
February 200226/12/2007Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's DiseaseA Double-Blind, Placebo-Controlled, Cross-Over Study of Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's DiseaseParkinson's DiseaseDrug: sildenafil;Drug: PlaceboLoma Linda UniversityNULLTerminated18 Years80 YearsAll2Phase 2United States
1747NCT00407212
(ClinicalTrials.gov)
January 200230/11/2006A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and EfficacyA Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Dose-ranging, Efficacy and Safety Study of Three Doses of TCH346 (1mg, 5mg and 20mg Daily) in Patients With Early Parkinson's DiseaseParkinson's DiseaseDrug: TCH346 (dibenz[b,f]oxepin-10-ylmethyl-prop-2-ynyl-amine, hydrogen maleate salt)NovartisNULLCompleted30 Years80 YearsBoth301Phase 1;Phase 2United States;Brazil;Canada;France;Germany;Italy;Netherlands;Portugal;United Kingdom
1748NCT00036218
(ClinicalTrials.gov)
December 20018/5/2002Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.A Phase III, Double-Blind, Placebo-Controlled, Randomized Study Comparing the Efficacy, Safety, and Tolerability of Sumanirole Versus Placebo or Ropinirole in Patients With Early Parkinson's Disease.Parkinson DiseaseDrug: sumanirole;Drug: ropinirolePfizerNULLCompleted30 YearsN/ABoth600Phase 3United States;Argentina;Mexico;Puerto Rico
1749NCT00203177
(ClinicalTrials.gov)
October 200113/9/2005Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy.Parkinson's DiseaseDrug: rasagiline mesylate;Drug: rasagiline mesylate 1.0 mgTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth254Phase 3United States;Canada
1750NCT02772627
(ClinicalTrials.gov)
September 200112/5/2016Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study to Investigate the Tolerability, Steady-state Pharmacokinetics and Erythrocyte COMT Inhibition of BIA 3-202 in Healthy Volunteers.Parkinson's DiseaseDrug: Nebicapone;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsBoth22Phase 1Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1751NCT00200525
(ClinicalTrials.gov)
July 200113/9/2005Continued Efficacy and Safety of Apomorphine in Patients With Late-Stage Parkinsons DiseaseA Randomized, Placebo-Controlled Study of the Continued Efficacy and Safety of SC Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing-Off Effects Associated With Late-Stage PD After Apomorphine UseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth60Phase 3NULL
1752NCT02763852
(ClinicalTrials.gov)
April 20014/5/2016Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg)Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth18Phase 1Portugal
1753NCT02763839
(ClinicalTrials.gov)
April 20014/5/2016Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg)Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Sinemet 25/100Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth19Phase 1Portugal
1754NCT00013624
(ClinicalTrials.gov)
March 200124/3/2001Riluzole to Treat Parkinson's DiseaseEffect of Antiglutamatergic Treatment in Parkinson's DiseaseParkinson's DiseaseDrug: IV LevodopaNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth20Phase 2United States
1755NCT00145171
(ClinicalTrials.gov)
February 20012/9/2005A Sub-Study With Patients in APO401 to Evaluate Adverse Events During Dose Introduction in Apomorphine-naïve Patients.Study of Orthostatic Changes Upon Apomorphine Dose Initiation in Late Stage Parkinson’s Disease Patients. A Dose Escalation Study With a Double-Blind Placebo-Controlled Efficacy Determination at 4 Mg.Parkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth56Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1756NCT00009048
(ClinicalTrials.gov)
January 200123/1/2001EMD 128130 for the Treatment of Parkinson's DiseaseEffect of Serotoninergic Treatment in Parkinson's DiseaseParkinson's DiseaseDrug: EMD 128130;Drug: IV LevodopaNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth30Phase 2United States
1757NCT00006337
(ClinicalTrials.gov)
October 20004/10/2000KW-6002 to Treat Parkinson's DiseaseAdenosine A2A Blockade With KW-6002 in Parkinson's DiseaseParkinson's DiseaseDrug: KW-6002;Drug: IV LevodopaNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth16Phase 2United States
1758NCT00203125
(ClinicalTrials.gov)
October 200013/9/2005A Study to Evaluate the Effects of Tyramine in Patients Who Completed the PRESTO Study.Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)Parkinson's DiseaseDrug: rasagiline mesylate;Other: tyramineTeva Pharmaceutical IndustriesNULLCompletedN/AN/ABoth55Phase 3United States
1759NCT00006488
(ClinicalTrials.gov)
October 20008/11/2000Continuously Infused Intracerebral (IC) Recombinant-Methionyl Human Glial Cell Line-Derived Neurotrophic Factor (r-metHuGDNF) for the Treatment of Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: recombinant-methionyl human glial cell line-derived neurotrophic factorNational Center for Research Resources (NCRR)NULLCompleted18 Years75 YearsBothPhase 1United States
1760NCT02763800
(ClinicalTrials.gov)
September 20004/5/2016Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202Double-Blind, Randomised, Placebo-Controlled, Rising Multiple Dose Study to Investigate the Safety, Tolerability, Steady State Pharmacokinetic and Pharmacodynamic Profile of BIA 3-202, in Young Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years35 YearsMale33Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1761NCT00070928
(ClinicalTrials.gov)
September 20009/10/2003Valerian to Improve Sleep in Patients With Parkinson's DiseasePolysomnographic Assessment of Alternative Treatments for Sleep Disturbance in Parkinson's DiseaseInsomnia;Parkinson's DiseaseDrug: valerianNational Center for Complementary and Integrative Health (NCCIH)NULLCompleted30 Years80 YearsBoth80Phase 2United States
1762NCT00006077
(ClinicalTrials.gov)
August 20004/8/2000Effects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's DiseaseEffects of Monoamine Reuptake Inhibitor NS2330 in Parkinson's DiseaseParkinson's DiseaseDrug: NS2330;Drug: Levodopa and DomperidoneNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth50Phase 2United States
1763NCT00036205
(ClinicalTrials.gov)
August 20008/5/2002Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's DiseaseOpen-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.Parkinson DiseaseDrug: sumanirolePfizerNULLTerminated30 YearsN/ABoth984Phase 3United States;Argentina;Colombia;Puerto Rico
1764NCT02231294
(ClinicalTrials.gov)
July 20002/9/2014The Effect of Sifrol® on Tremor and Depression in Patients With Idiopathic Parkinson's DiseaseThe Effect of SIFROL® on Tremor and Depression in Patients With Idiopathic Parkinson's Disease Patients.Parkinson DiseaseDrug: Sifrol®Boehringer IngelheimNULLCompletedN/AN/ABoth1464N/ANULL
1765NCT00203034
(ClinicalTrials.gov)
May 200013/9/2005Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor FluctuationsA Multicenter, US and Canada, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study, for the Efficacy, Tolerability and Safety of Rasagiline Mesylate in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: rasagiline mesylate;Drug: 1.0 mg rasagiline mesylate;Other: PlaceboTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth472Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1766NCT02763787
(ClinicalTrials.gov)
April 20004/5/2016Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Single Doses of BIA 3-202 in Healthy Volunteers.Parkinson's DiseaseDrug: BIA 3-202;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years35 YearsMale71Phase 1United Kingdom
1767NCT00134784
(ClinicalTrials.gov)
April 200023/8/2005Long-Term Dopamine Transporter Imaging and Clinical Assessment of Parkinson's Disease Progression[123I]ß-CIT and SPECT in Vivo Three Year Imaging Assessment of Dopamine Transporter Density in Subjects With Early Parkinson's Disease Participating in Earlier vs. Later Levodopa in Parkinson's DiseaseParkinson DiseaseDrug: [123I]B-CIT SPECT imagingInstitute for Neurodegenerative DisordersUnited States Department of DefenseCompleted22 YearsN/AAll142Phase 2NULL
1768NCT00004576
(ClinicalTrials.gov)
February 200017/2/2000Study of LY300164 for the Treatment of Parkinson's DiseaseAMPA Receptor Blockade With LY300164 in the Treatment of Parkinson's DiseaseDyskinesias;Parkinson DiseaseDrug: LY300164National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth20Phase 2United States
1769NCT00200512
(ClinicalTrials.gov)
September 199913/9/2005Continued Efficacy of Apomorphine After Previous Exposure of at Least Three MonthsA Prospective, Randomized, Placebo-Controlled, Crossover Study of the Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off Episodes in Patients With On/Off or Wearing Off Effects Associated With Late Stage Parkinson's DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth16Phase 2;Phase 3United Kingdom
1770NCT00142545
(ClinicalTrials.gov)
July 199931/8/2005Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's DiseaseLong-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off” Episodes in Patients With On-Off” or Wearing-Off” Effects Associated With Late-Stage Parkinson’s DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth800Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1771NCT00001931
(ClinicalTrials.gov)
May 199931/7/2007Treatment of Parkinson's Disease With a Transdermal Skin PatchTransdermal Application of Dopamine Agonist N-0923 in Parkinson's DiseaseParkinson DiseaseDrug: N-0923National Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth20Phase 2United States
1772NCT02172573
(ClinicalTrials.gov)
April 199920/6/2014Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's DiseaseA Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole;Drug: Bromocriptine;Drug: Placebo pramipexole;Drug: Placebo bromocriptineBoehringer IngelheimNULLCompleted20 YearsN/ABoth315Phase 3NULL
1773NCT00001929
(ClinicalTrials.gov)
March 19993/11/1999Treatment of Parkinson's Disease With EliprodilNMDA-Receptor Blockade With Eliprodil in Parkinson's DiseaseMovement Disorders;Parkinson DiseaseDrug: EliprodilNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth20Phase 2United States
1774NCT00274131
(ClinicalTrials.gov)
December 19989/1/2006Long-term Administration Study of SND 919 Tablets in Parkinson's DiseaseLong-term Administration Study of SND 919 Tablets in Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole 0.125 mg tablets;Drug: Pramipexole 0.5 mg tabletsBoehringer IngelheimNULLCompleted20 YearsN/ABoth170Phase 3NULL
1775NCT02177357
(ClinicalTrials.gov)
November 199824/6/2014Pramipexole in Untreated and Levodopa-treated Parkinson's Disease PatientsPramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational StudyParkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted30 YearsN/ABoth150Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1776NCT02248220
(ClinicalTrials.gov)
October 199822/9/2014Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's DiseaseObservation of the Efficacy and Tolerability of Sifrol® (Pramipexole) in Patients With Advanced Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: PramipexoleBoehringer IngelheimNULLCompletedN/AN/ABoth657N/ANULL
1777NCT00004731
(ClinicalTrials.gov)
September 199825/2/2000Parkinson's Disease Treatment With Coenzyme Q10Effects of Coenzyme Q10 in Early Parkinson's DiseaseParkinson's DiseaseDrug: Coenzyme Q10National Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted30 YearsN/ABothPhase 2United States
1778NCT02233023
(ClinicalTrials.gov)
June 19984/9/2014Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's DiseaseMatched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole;Drug: Bromocriptine and other dopamine agonistsBoehringer IngelheimNULLCompletedN/AN/ABoth705Phase 4NULL
1779NCT00004733
(ClinicalTrials.gov)
January 199825/2/2000Timing of Levodopa Treatment in Parkinson's DiseaseEarlier Versus Later L-Dopa in Parkinson's DiseaseParkinson's DiseaseDrug: levodopaNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompleted30 YearsN/ABothPhase 3United States
1780NCT00203060
(ClinicalTrials.gov)
July 199713/9/2005Effectiveness, Tolerability and Safety of Rasagiline in Early Parkinson's Disease Patients Not Treated With LevodopaA Multicenter, Double-Blind, Placebo-Controlled, Parallel Group, Phase III Clinical Trial For The Efficacy, Tolerability And Safety Of Two Doses Of Rasagiline Mesylate In Early Parkinson's Disease (PD) Patients Not Treated With LevodopaParkinson's DiseaseDrug: Rasagiline Mesylate;Drug: placeboTeva Neuroscience, Inc.NULLCompleted35 YearsN/ABoth404Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1781NCT00038116
(ClinicalTrials.gov)
May 199529/5/2002Embryonic Dopamine Cell Implants for Parkinson's DiseaseEmbryonic Dopamine Cell Implants for Parkinson's Disease: A Double-Blind StudyParkinson DiseaseProcedure: embryonic dopamine cell implant surgery;Procedure: placeboUniversity of Colorado, DenverNULLCompleted20 Years75 YearsBoth40Phase 3United States
1782NCT00004826
(ClinicalTrials.gov)
October 199324/2/2000Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: clozapineMemorial Hospital of Rhode IslandNULLCompletedN/AN/ABoth60N/ANULL
1783NCT00001365
(ClinicalTrials.gov)
July 19933/11/1999Dextromethorphan for the Treatment of Parkinson's Disease and Similar Conditions of the Nervous SystemNMDA Receptor Antagonist Treatment of Neurodegenerative DiseaseNeurodegenerative Disease;Parkinson's DiseaseDrug: dextromethorphanNational Institute of Neurological Disorders and Stroke (NINDS)NULLCompletedN/AN/ABoth42Phase 2United States
1784NCT00132626
(ClinicalTrials.gov)
September 199218/8/2005Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian SyndromeDynamic SPECT Imaging With [123I]ß-CIT in Patients With ParkinsonismParkinson's Disease;Parkinsonian SyndromeDrug: [123I]ß-CIT and SPECT imagingInstitute for Neurodegenerative DisordersMolecular NeuroImaging;National Institutes of Health (NIH)Completed35 YearsN/AAll500Phase 2NULL
1785JPRN-JapicCTI-121954
Phase III study on FPF1100NW monotherapyRandomized, double-blind, placebo-controlled study on FPF1100NW monotherapy with early Parkinson's disease patients (Phase III study) Early Parkinson's diseaseIntervention name : FPF1100NW
INN of the intervention : Selegiline
Dosage And administration of the intervention : oral
Control intervention name : null
FP Pharmaceutical Corp.NULL2074BOTH280Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1786JPRN-JapicCTI-070377
28/03/2007Double-blind, parallel-group confirmatory study of AD-810N (zonisamide) in patients with Parkinson's diseaseDouble-blind, parallel-group confirmatory study of AD-810N (zonisamide) in patients with Parkinson's disease Parkinson's diseaseIntervention name : AD-810N (zonisamide)
Dosage And administration of the intervention : oral
Dainippon Sumitomo Pharma Co., Ltd.NULL2074BOTHPhase 3NULL
1787EUCTR2011-002073-30-DE
(EUCTR)
20/09/2011Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias12-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
63France;United States;Hungary;Canada;Spain;Germany;Italy
1788EUCTR2008-004447-11-DE
(EUCTR)
17/10/2008A Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s DiseaseA Phase IIb Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy and Safety of Apomorphine Inhalation Powder in Patients With On-Off” or Wearing-Off” Effects Associated With Parkinson’s Disease Unpredictable motor fluctuation or On-Off” or Wearing-Off” Effects Fluctuating associated with Idiopathic Parkinson’s Disease
MedDRA version: 11;Level: LLT;Classification code 10067209;Term:
Product Name: Apomorphine hydrochloride 1.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 2.8mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 4.0 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Product Name: Apomorphine hydrochloride 5.8 mg inhalation powder, pre-dispensed
Product Code: VR040
INN or Proposed INN: Apomorphine hydrochloride
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
66Phase 2bGermany;Italy;United Kingdom
1789EUCTR2009-014341-84-DE
(EUCTR)
07/10/2009Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms.Non-GI: A multi site, open-label, interventional Pilot study assessing the switch from oral treatment to rotigotine transdermal patch (Neupro) in Parkinson's disease patients with identified gastrointestinal symptoms. idiopathic Parkinson's disease
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2 mg/24 h transdermal patch
Product Name: Rotigotine transdermal patch 2mg/24h(10cm2)
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4 mg/24 h transdermal patch
Product Name: Rotigotine transdermal patch 4mg/24h (20cm2)
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6 mg/24 h transdermal patch
Product Name: Rotigotine transdermal patch 6mg/24h (30cm2)
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8 mg/24 h transdermal patch
Product Name: Rotigotine transdermal patch 8mg/24h (40cm2)
INN or Proposed INN: rotigotine
Schwarz Pharma Deutschland GmbH, UCB GroupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
1790JPRN-JapicCTI-050099
12/09/2005Double blind, parallel-group clinical study of AD-810N (zonisamide) for Parkinson's diseaseDouble blind, parallel-group clinical study of AD-810N (zonisamide) for Parkinson's disease Parkinson's diseaseIntervention name : AD-810N (zonisamide)
Dosage And administration of the intervention : oral
Dainippon Sumitomo Pharma Co., Ltd.NULL2079BOTHNANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1791JPRN-JapicCTI-111699
22/11/2011Study of Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's DiseaseAn Open-Label, Single-Arm, Baseline-Controlled, Multicenter Study to Explore the Safety, Tolerability, Pharmacokinetics, and Efficacy of ABT-SLV187 in Subjects with Advanced Parkinson's Disease Advanced Parkinson's diseaseIntervention name : ABT-SLV187
Dosage And administration of the intervention : Usually 2-6 ml/hour (40-120 mg levodopa/hour), dose will be individually optimized for each subject based on the subject's symptoms
Control intervention name : null
Abbott Japan Co., Ltd.NULL30BOTH8Phase 2NULL
1792EUCTR2006-001755-36-DE
(EUCTR)
15/08/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
1793EUCTR2008-005492-94-DE
(EUCTR)
11/08/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand
1794EUCTR2010-022200-46-DE
(EUCTR)
13/04/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Latvia;Germany
1795JPRN-JapicCTI-101020
Phase II study on FPF1100NW monotherapyStudy on FPF1100NW monotherapy with early Parkinson's disease patients (Phase II study) Parkinson's diseaseIntervention name : FPF1100NW
INN of the intervention : Selegiline
Dosage And administration of the intervention : oral
Control intervention name : null
FP Pharmaceutical Corp.NULL2074BOTH90Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1796EUCTR2009-013552-72-DE
(EUCTR)
23/08/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Product Name: Preladenant
Product Code: SCH 420814
INN or Proposed INN: Preladenant
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Trade Name: Azilect
Product Name: Azilect
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESYLATE
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.NULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
1797EUCTR2006-006907-35-DE
(EUCTR)
30/01/2007Long-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVERLong-term extension of RECOVER A MULTICENTER, MULTINATIONAL, PHASE 3B, OPEN-LABEL EXTENSION TRIAL TO EVALUATE THE LONG-TERM EFFECT OF THE 24-HOUR TRANSDERMAL DELIVERY OF ROTIGOTINE ON MOTOR FUNCTION, SLEEP QUALITY, AND NOCTURNAL AND NON-MOTOR SYMPTOMS IN SUBJECTS WITH IDIOPATHIC PARKINSON’S DISEASE - Long-term extension of RECOVER Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Neupro 2mg/24h transdermal patch
Product Code: ND1587
INN or Proposed INN: Rotigotine
Trade Name: Neupro 4mg/24h transdermal patch
Product Code: ND1589
INN or Proposed INN: Rotigotine
Trade Name: Neupro 6mg/24h transdermal patch
Product Code: ND1590
INN or Proposed INN: Rotigotine
Trade Name: Neupro 8mg/24h transdermal patch
Product Code: ND1702
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
270Phase 3BHungary;Finland;United Kingdom;Germany;Spain;Italy;Austria
1798EUCTR2016-000657-12-AT
(EUCTR)
17/10/2016A Global Study to Assess the Drug Dynamics, Efficacy, and Safety of GZ/SAR402671 in Parkinson's Disease Patients Carrying a Glucocerebrosidase (GBA) Gene MutationMulticenter, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of GZ/SAR402671 in Patients with Early-stage Parkinson's Disease Carrying a GBA Mutation or Other Pre-specified Variant - MOVES-PD Parkinson's disease (PD) carrying a GBA mutation
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: Genz-682452-AU
Product Name: Venglustat
Product Code: SAR402671, GZ402671 or GZ/SAR402671
INN or Proposed INN: venglustat malate
Other descriptive name: Genz-682452-AU
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
290Phase 2United States;Portugal;Taiwan;Greece;Spain;Austria;Israel;United Kingdom;Italy;France;Canada;Singapore;Australia;Germany;Norway;Japan;Sweden