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"
953 trials found
No.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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agemax
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gender
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size
PhaseCountries
1NCT04665869
(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
2NCT04625361
(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
3NCT04491383
(ClinicalTrials.gov)
January 202122/7/2020Tocotrienols in Parkinson's Disease (PD)Tocotrienols in Parkinson's Disease (PD): A Pilot, Randomised, Placebo-controlled TrialNeuro-Degenerative Disease;Parkinson DiseaseDrug: Tocovid Suprabio;Other: PlaceboNational Neuroscience InstituteHovid BerhadNot yet recruiting50 Years90 YearsAll100Phase 2Singapore
4NCT04643327
(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
5NCT04377945
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04658186
(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
7NCT04651153
(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
8NCT04147949
(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
9NCT04506073
(ClinicalTrials.gov)
November 9, 202016/7/2020Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for iPDAllogeneic Bone Marrow-derived Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease: Phase IIa Double-blind Randomized Placebo Controlled TrialParkinson's DiseaseDrug: MSC+placebo;Drug: MSC;Drug: PlaceboThe University of Texas Health Science Center, HoustonMichael J. Fox Foundation for Parkinson's ResearchRecruiting50 Years79 YearsAll45Phase 2United States
10NCT04277247
(ClinicalTrials.gov)
November 2, 202010/2/2020Botulinum Toxin Type A for Foot Dystonia-associated Pain in Parkinson's DiseaseBotulinum Toxin A (Onabotulinumtoxin A) for Foot Dystonia-associated Pain in Parkinson's Disease: A Randomized, Double-blind Placebo Control StudyDystonia Disorder;Parkinson DiseaseDrug: Botulinum toxin type A;Drug: PlaceboUniversity of CalgaryAllerganRecruiting30 Years100 YearsAll40Phase 2;Phase 3Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04435431
(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
12NCT04542499
(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
13JPRN-jRCTs031200172
26/10/202026/10/2020Effects of Elobixibat administration in patients with Parkinson's syndrome complicated with chronic constipationMulticenter, Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study Investigating the Efficacy and Safety of Elobixibat in Patients with Parkinson's Disease Complicating Chronic Constipation. - CONST-PD Parkinson's disease, chronic constipation
Parkinson's syndrome,chronic constipation,Symptomatic constipation
Take 10mg of Elobixibat or placebo once a day before meal. After the 2-week screening period, the study drug will be started on the day of enrollment.Hatano TakuMochida Pharmaceutical Co., Ltd.;EA Pharma Co., Ltd.Recruiting>= 20age oldNot applicableBoth100N/AJapan
14NCT03947216
(ClinicalTrials.gov)
October 23, 20207/5/2019Randomized Placebo Controlled Trial Evaluating the Efficacy of Pimavanserin, a Selective Serotonin 5-HydroxyTryptamine-2A (5HT2A) Inverse Agonist, to Treat Impulse Control Disorders in Parkinson's Disease.Study of Pimavanserin Efficacy for the Treatment of Impulse Control Disorders in Parkinson's DiseaseParkinson DiseaseDrug: Active drug: pimavanserin 17mg (2 strength tablets);Drug: Placebo: 2 tablets containing same excipients except active compound;Behavioral: Assessment of severity of ICD (impulse control disorders);Behavioral: Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors;Behavioral: Assessment of quality of life;Behavioral: Assessment of depression;Behavioral: Assessment of cognition;Behavioral: Assessment of severity of Parkinson Disease;Procedure: Blood analysis;Procedure: Cardiac monitoringUniversity Hospital, Strasbourg, FranceNS-PARK;EUCLID;F-CRINRecruiting35 Years75 YearsAll130Phase 2France
15NCT04334317
(ClinicalTrials.gov)
October 21, 202030/3/2020Effect of TAK-071 on Falls in Participants With Parkinson Disease (PD)A Randomized, Double-blind, Placebo-Controlled, 2-Period Crossover, Phase 2 Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral TAK-071 in Parkinson Disease Patients With Cognitive Impairment and an Elevated Risk of FallsParkinson's DiseaseDrug: TAK-071;Drug: PlaceboTakedaMichael J. Fox Foundation for Parkinson's ResearchRecruiting40 Years85 YearsAll64Phase 2United States
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
16ChiCTR2000038852
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
17NCT04380142
(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
18NCT03665493
(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
19NCT03968133
(ClinicalTrials.gov)
September 30, 202028/5/2019Treating Anxiety in Parkinson's Disease With a Multi-Strain ProbioticTreating Anxiety in Parkinson's Disease With a Multi-Strain Probiotic - a Randomized, Placebo-controlled TrialParkinson Disease;AnxietyDietary Supplement: Probiotic;Dietary Supplement: PlaceboUniversity of British ColumbiaThe W. Garfield Weston FoundationNot yet recruiting40 Years80 YearsAll72Phase 2Canada
20EUCTR2020-001175-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-002949-38-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
22ChiCTR2000035872
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
23NCT04524351
(ClinicalTrials.gov)
August 14, 202011/8/2020Posiphen® Dose-Finding, Biomarker Study in Early Alzheimer's and Parkinson's PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD) or Early Parkinson's Disease (PD)Alzheimer Disease;Parkinson DiseaseDrug: PosiphenAnnovis Bio Inc.ParexelRecruiting45 YearsN/AAll68Phase 1;Phase 2United States
24NCT04449484
(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
25EUCTR2019-002951-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-002951-40-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
27NCT04193527
(ClinicalTrials.gov)
July 20202/12/2019A Study to Evaluate the Diagnostic Efficacy of DaTSCAN™ Ioflupane (123I) Injection in Single Photon Emission Computed Tomography (SPECT) for the Diagnosis of Parkinsonian Syndrome (PS) in Chinese PatientsA Multicentre, Phase 3, Clinical Study to Compare the Striatal Uptake of a Dopamine Transporter Radioligand, DaTSCAN™ Ioflupane (123I) Injection, After Intravenous Administration to Chinese Patients With a Diagnosis of Parkinson's Disease, Multiple System Atrophy, Progressive Supranuclear Palsy, or Essential Tremor and to Healthy ControlsParkinsonian Syndrome;Parkinson Disease(PD);Multiple System Atrophy (MSA);Progressive Supranuclear Palsy (PSP)Drug: DaTSCAN™ Ioflupane (123I) InjectionGE HealthcarePPDNot yet recruiting40 Years80 YearsAll172Phase 3China
28EUCTR2018-004156-37-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
29EUCTR2018-004156-37-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
30NCT04428112
(ClinicalTrials.gov)
June 5, 20209/6/2020Rural Dementia Caregiver ProjectEvaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related DementiasDepression;Stress, Psychological;Self Efficacy;Loneliness;Social Isolation;Health Care Utilization;Dementia;Dementia Alzheimers;Dementia of Alzheimer Type;Dementia, Vascular;Dementia Frontal;Dementia, Lewy Body;Dementia, Mixed;Dementia in Parkinsons Disease;Dementia, HIV;Dementia Frontotemporal;Dementia, Multi-InfarctBehavioral: Building Better Caregivers Workshop;Behavioral: Attention ControlUniversity of California, San FranciscoNational Institute on Aging (NIA)Recruiting18 YearsN/AAll640N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2019-002951-40-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
32EUCTR2018-004156-37-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
33NCT03568968
(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
34EUCTR2019-002949-38-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
35NCT04571164
(ClinicalTrials.gov)
May 11, 202021/9/2020A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDA Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDParkinson DiseaseDrug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheresLuye Pharma Group Ltd.ParexelRecruiting30 YearsN/AAll294Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2019-002950-22-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
37EUCTR2018-004156-37-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
38EUCTR2018-004156-37-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
39EUCTR2018-002233-37-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
40EUCTR2019-002951-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2019-002949-38-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
42EUCTR2020-000686-16-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
43EUCTR2019-002949-38-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
44NCT04127695
(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
45EUCTR2018-004156-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT04154072
(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
47EUCTR2018-004156-37-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
48EUCTR2019-002949-38-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
49EUCTR2018-003289-15-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
50NCT04322227
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04220762
(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
52NCT04232969
(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
53NCT04369430
(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
54EUCTR2018-004156-37-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
55EUCTR2019-001657-42-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-003289-15-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
57NCT04223193
(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
58NCT04226248
(ClinicalTrials.gov)
January 2, 20205/12/2019CHIEF PD (CHolinesterase Inhibitor to prEvent Falls in Parkinson's Disease)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.Parkinson DiseaseDrug: Rivastigmine Transdermal System;Other: Placebo Transdermal SystemUniversity of BristolRoyal United Hospitals Bath NHS Foundation TrustRecruiting18 YearsN/AAll600Phase 3United Kingdom
59EUCTR2018-004156-37-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
60NCT04164121
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT04097080
(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
62NCT04201093
(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
63EUCTR2018-003089-14-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
64NCT04191577
(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
65NCT04044131
(ClinicalTrials.gov)
December 1, 201917/7/2019Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) and Parkinson's Disease (PD) PatientsA Phase 2, Randomized, Placebo Controlled Study to Evaluate the Efficacy, Tolerability and Safety of Metabolic Cofactor Supplementation in Alzheimer's Disease (AD) And Parkinson's Disease (PD) PatientsAlzheimer Disease;Parkinson DiseaseDrug: Metabolic Cofactor Supplementation;Drug: SorbitolIstanbul Medipol University HospitalScandiBio Therapeutics AB;Alanya Alaaddin Keykubat University;Sahlgrenska University Hospital, Sweden;KTH Royal Institute of TechnologyRecruiting18 YearsN/AAll120Phase 2Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03436953
(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
67EUCTR2018-004156-37-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
68NCT03924414
(ClinicalTrials.gov)
November 15, 20192/4/2019Trial of Parkinson's And Zoledronic AcidTOPAZ: Trial of Parkinson's And Zoledronic Acid A Randomized Placebo-controlled Trial of Zoledronic Acid for the Prevention of Fractures in Patients With Parkinson's DiseaseParkinson Disease;Osteoporosis;ParkinsonismDrug: Zoledronic Acid 5Mg/Bag 100Ml Inj;Other: PlaceboCalifornia Pacific Medical Center Research InstituteNational Institute on Aging (NIA);University of California, San Francisco;Duke University;University of Pittsburgh;Parkinson's FoundationRecruiting60 YearsN/AAll3500Phase 4United States
69NCT03652870
(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
70EUCTR2018-002942-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT04164758
(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
72EUCTR2019-001657-42-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
73EUCTR2018-003337-15-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
74NCT04157933
(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
75NCT04165837
(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
76EUCTR2018-002233-37-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
77EUCTR2018-003289-15-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
78NCT03987750
(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
79ChiCTR1900025894
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
80EUCTR2018-003028-35-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
81NCT04006210
(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
82NCT04043338
(ClinicalTrials.gov)
August 11, 201924/7/2019Single Ascending Dose Study Investigating the Safety, Tolerability, and PK of XC130-A10H in Healthy Adult SubjectsA Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study Investigating the Safety, Tolerability, and Pharmacokinetics of XC130-A10H in Healthy Adult SubjectsParkinson's DiseaseDrug: XC130-A10H;Drug: PlaceboXoc PharmaceuticalsCelerionRecruiting18 Years75 YearsAll40Phase 1United States
83NCT03881371
(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
84NCT04056689
(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
85NCT03956979
(ClinicalTrials.gov)
July 22, 201917/5/2019A Study in Parkinson's Disease in paTients With mOderate to seveRe dyskInesiAA 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-010DyskinesiasDrug: JM-010 group A;Drug: JM-010 group B;Drug: PlacebosContera PharmaBukwang PharmaceuticalRecruiting18 Years80 YearsAll81Phase 2Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2018-003289-15-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
87EUCTR2018-003289-15-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
88ChiCTR1900021708
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
89NCT03977441
(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
90EUCTR2018-003219-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2018-003289-15-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
92EUCTR2018-003337-15-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
93EUCTR2018-003337-15-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
94EUCTR2018-003289-15-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
95ChiCTR1900022534
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03971617
(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
97NCT03671785
(ClinicalTrials.gov)
May 15, 201912/9/2018Study of the Fecal Microbiome in Patients With Parkinson's DiseaseA Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Twice Weekly Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally for 12 Weeks in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: PRIM-DJ2727;Drug: Placebo oral capsuleThe University of Texas Health Science Center, HoustonKelsey Research FoundationRecruiting55 Years75 YearsAll12Phase 1United States
98NCT03552068
(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
99EUCTR2018-003289-15-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
100NCT03970239
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2018-003289-15-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
102NCT03899324
(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
103JPRN-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
104EUCTR2018-002233-37-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
105EUCTR2018-003289-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03841604
(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
107EUCTR2016-000657-12-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
108NCT03716570
(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
109ChiCTR1900021760
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
110NCT03655236
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03413384
(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
112EUCTR2017-003458-18-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
113EUCTR2017-002426-20-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
114EUCTR2018-002877-23-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
115NCT04620863
(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
116NCT03727295
(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
117ChiCTR1800019942
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
118NCT03840005
(ClinicalTrials.gov)
December 18, 201811/2/2019Trial of Ursodeoxycholic Acid (UDCA) for Parkinson's Disease: The UP StudyA 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)Parkinson's DiseaseDrug: UrsonormSheffield Teaching Hospitals NHS Foundation TrustJP Moulton Charitable Foundation;PRO.MED.CS Praha a.s.;Clinical Trials Research Unit, University of SheffieldActive, not recruiting18 Years75 YearsAll30Phase 2United Kingdom
119NCT03781791
(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
120NCT03710707
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT03823638
(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
122NCT03713957
(ClinicalTrials.gov)
November 12, 201818/10/2018A Study to Assess the Safety of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive ImpairmentA Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of GRF6021 Infusions in Subjects With Parkinson's Disease and Cognitive ImpairmentParkinson DiseaseDrug: GRF6021;Other: PlaceboAlkahest, Inc.Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years85 YearsAll79Phase 2United States;Australia;France
123EUCTR2018-001887-46-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
124NCT03670953
(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
125NCT04629404
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03069911
(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
127JPRN-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
128EUCTR2016-002033-30-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
129EUCTR2017-003415-19-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
130EUCTR2017-002426-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT04048291
(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
132NCT04451096
(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
133EUCTR2016-004610-95-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
134NCT03582137
(ClinicalTrials.gov)
September 17, 201817/4/2018A Study of Tolerability and Efficacy of Cannabidiol on Motor Symptoms in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Parallel Study of Tolerability and Efficacy of Cannabidiol (CBD) on Motor Symptoms in Parkinson's DiseaseParkinson DiseaseDrug: Cannabidiol;Other: PlaceboUniversity of Colorado, DenverColorado Department of Public Health and EnvironmentRecruiting40 Years85 YearsAll75Phase 2United States
135NCT04202757
(ClinicalTrials.gov)
September 14, 201821/9/2018Intravenous Plasma Treatment for Parkinson's DiseaseIntravenous Young Fresh Frozen Plasma (yFFP) Investigational Treatment for Parkinson's Disease - Randomized Controlled StudyIdiopathic Parkinson DiseaseBiological: [21CFR640.30] Plasma from 18 - 25 year old volunteer donors;Other: SalineThe Neurology CenterCarolina Longevity InstituteCompleted45 Years90 YearsAll18Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT03608371
(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
137NCT03621046
(ClinicalTrials.gov)
August 20, 20186/6/2018Use of Low-dose Zolpidem in Parkinson's DiseaseA Placebo Controlled Double Blind Randomised Controlled Proof of Concept Study of Zolpidem for the Treatment of Motor and Cognitive Deficits in Late-stage Parkinson'sParkinson DiseaseDrug: Zolpidem;Other: PlaceboAston UniversityUniversity Hospital Birmingham NHS Foundation TrustCompleted40 Years80 YearsAll28Phase 2United Kingdom
138NCT03675282
(ClinicalTrials.gov)
August 14, 20185/9/2018Quantitative Mapping of Substantia Nigra Iron in Parkinson's Disease (Stages I-IV, REM Sleep Behavior Disorder) and ControlsQuantitative Mapping of Substantia Nigra Iron in Parkinson's Disease and ControlsParkinson Disease;REM Sleep Behavior Disorder;HealthyDrug: (11C)PE2IWeill Medical College of Cornell UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Recruiting20 Years100 YearsAll100Phase 1;Phase 2United States
139EUCTR2016-004610-95-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
140ChiCTR1800017084
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03611569
(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
142NCT03594656
(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
143NCT03774459
(ClinicalTrials.gov)
July 9, 20188/12/2018ANAVEX2-73 Study in Parkinson's Disease DementiaA Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients With Parkinson's Disease With DementiaParkinsons Disease With DementiaDrug: High dose ANAVEX2-73;Drug: Mid dose ANAVEX2-73;Drug: Placebo oral capsuleAnavex Life Sciences Corp.Anavex Germany GmbHCompleted50 Years85 YearsAll132Phase 2Australia;Spain
144NCT03146130
(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
145EUCTR2017-004335-36-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
146NCT03521635
(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
147NCT03562494
(ClinicalTrials.gov)
June 28, 201816/5/2018VY-AADC02 for Parkinson's Disease With Motor Fluctuations (RESTORE-1)A Randomized, Sham Surgery Controlled, Double-blind, Multi-center, Phase 2 Clinical Trial, Evaluating the Efficacy and Safety of VY-AADC02 in Moderate to Advanced Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseBiological: VY-AADC02;Other: Sham (Placebo) SurgeryNeurocrine BiosciencesVoyager TherapeuticsRecruiting40 Years75 YearsAll85Phase 2United States
148NCT03439943
(ClinicalTrials.gov)
June 13, 201813/2/2018Study to Evaluate the Effect of Lixisenatide in Patient With Parkinson's DiseaseMulticenter, Randomised, Placebo-controlled, Double Blinded, Parallel Arm Proof-of-concept Trial of Lixisenatide in Patients With Early Parkinson's DiseaseParkinson DiseaseDrug: Lixisenatide;Drug: placeboUniversity Hospital, ToulouseCure Parkinson;Réseau NS-Park;EUCLID;SanofiActive, not recruiting40 Years75 YearsAll156Phase 2France
149EUCTR2016-004610-95-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
150EUCTR2017-004475-31-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
151NCT03541356
(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
152EUCTR2016-004610-95-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
153EUCTR2017-004475-31-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
154NCT03368170
(ClinicalTrials.gov)
April 12, 20185/12/2017Efficacy and Tolerability of IRL790 in Parkinson's Disease DyskinesiaA Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease DyskinesiaParkinson DiseaseDrug: Mesdopetam (IRL790)Integrative Research Laboratories ABThe Clinical Trial CompanyCompleted18 Years79 YearsAll75Phase 2Sweden;United Kingdom
155EUCTR2017-004297-34-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
156EUCTR2016-004610-95-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
157NCT03882398
(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
158NCT03189563
(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
159NCT03331848
(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
160NCT03318523
(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
161EUCTR2017-000087-15-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
162EUCTR2017-003458-18-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
163EUCTR2017-000877-35-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
164NCT03377322
(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
165EUCTR2016-002033-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2016-002033-30-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
167EUCTR2017-000877-35-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
168NCT03272165
(ClinicalTrials.gov)
October 17, 201729/6/2017Single Ascending Dose Study of MEDI1341 in Healthy VolunteersA Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI1341 in Healthy Male and Female Volunteers.Parkinson's DiseaseDrug: MEDI1341;Drug: PlaceboAstraZenecaCovance;MMS Holdings, Inc;CatalentRecruiting18 Years80 YearsAll48Phase 1United States;United Kingdom
169NCT03205488
(ClinicalTrials.gov)
October 16, 201728/6/2017Nilotinib in Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Phase IIa, Parallel Group, Two Cohort Study to Define the Safety, Tolerability, Clinical and Exploratory Biological Activity of the Chronic Administration of Nilotinib in Participants With Parkinson's DiseaseParkinson DiseaseDrug: Cohort 1:Nilotinib Oral Capsules (150mg or 300mg);Drug: Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1);Drug: PlaceboNorthwestern UniversityUniversity of Rochester;University of Iowa;Michael J. Fox Foundation for Parkinson's ResearchCompleted40 Years79 YearsAll76Phase 2United States
170EUCTR2017-001673-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT03769896
(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
172ChiCTR1800019216
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
173NCT03257046
(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
174EUCTR2015-004175-73-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
175NCT03295786
(ClinicalTrials.gov)
September 26, 201714/9/2017Clinical Study to Test the Safety of CDNF by Brain Infusion in Patients With Parkinson's DiseasePhase 1-2, Randomised, Double-Blind, Placebo Controlled, Safety and Tolerability Study of Intraputamenal Cerebral Dopamine Neurotrophic Factor (CDNF) Infusions Via an Investigational Drug Delivery System to Patients With Parkinson's DiseaseParkinson Disease;Movement Disorders;Neurodegenerative Diseases;Nervous System Diseases;Brain DiseasesDrug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery SystemHerantis Pharma Plc.Renishaw plc.Completed35 Years75 YearsAll17Phase 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
176EUCTR2017-000192-86-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
177NCT03306329
(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
178EUCTR2017-000087-15-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
179NCT04162275
(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
180EUCTR2017-000877-35-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
181EUCTR2017-000877-35-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
182NCT03187301
(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
183EUCTR2017-000877-35-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
184ChiCTR-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
185EUCTR2017-000087-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2017-000087-15-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
187NCT03412513
(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
188NCT03026231
(ClinicalTrials.gov)
July 15, 201711/1/2017Characterization of Fecal Microbiome Changes After Administration of PRIM-DJ2727 in Parkinson's Disease PatientsA Prospective, Randomized Placebo Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Weekly Administration of Lyophilized PRIM-DJ2727 Given Orally in Subjects With Parkinson's DiseaseParkinson's DiseaseBiological: PRIM-DJ2727;Drug: Placebo (for PRIM-DJ2727)The University of Texas Health Science Center, HoustonKelsey Research FoundationWithdrawn45 Years70 YearsAll0Phase 1;Phase 2United States
189ChiCTR-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
190EUCTR2017-000135-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT03162874
(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
192NCT03100149
(ClinicalTrials.gov)
June 27, 201729/3/2017A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II 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 ExtensionParkinson's DiseaseDrug: RO7046015;Drug: PlaceboHoffmann-La RocheProthena Biosciences LimitedActive, not recruiting40 Years80 YearsAll316Phase 2United States;Austria;France;Germany;Spain
193NCT03195231
(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
194EUCTR2017-000135-14-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
195EUCTR2017-000135-14-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2017-000135-14-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
197EUCTR2017-000135-14-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
198NCT03242499
(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
199NCT03047629
(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
200NCT02702076
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT03115827
(ClinicalTrials.gov)
April 18, 20179/3/2017Norepinephrine-targeted Therapy for Action Control in Parkinson DiseaseNorepinephrine-targeted Therapy for Action Control in Parkinson DiseaseParkinson DiseaseDrug: Droxidopa;Drug: CarbidopaVanderbilt University Medical CenterH. Lundbeck A/S;American Academy of NeurologyCompleted18 YearsN/AAll15Phase 4United States
202NCT02953665
(ClinicalTrials.gov)
April 3, 201721/10/2016Safety and Efficacy of Liraglutide in Parkinson's DiseaseA Phase II, Randomized, Double-blinded, Placebo-controlled Trial of Liraglutide in Parkinson's DiseaseParkinson DiseaseDrug: Liraglutide;Drug: PlaceboCedars-Sinai Medical CenterThe Cure Parkinson's Trust;Novo Nordisk A/SActive, not recruiting25 Years85 YearsAll63Phase 2United States
203NCT02970019
(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
204EUCTR2016-001575-71-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
205EUCTR2016-000657-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2016-000657-12-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
207EUCTR2016-000657-12-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
208NCT03037203
(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
209NCT03034564
(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
210NCT02954978
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2016-001575-71-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
212EUCTR2016-002033-30-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
213NCT02906020
(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
214NCT02934919
(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
215EUCTR2016-002033-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2015-004912-39-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
217EUCTR2016-000102-11-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
218EUCTR2016-000657-12-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
219EUCTR2016-001762-29-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
220NCT03531060
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2016-002033-30-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
222ChiCTR-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
223EUCTR2016-000657-12-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
224NCT02847650
(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
225NCT02935842
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT02910102
(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
227NCT02818777
(ClinicalTrials.gov)
October 20166/5/2016A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's DiseaseA Randomized, Double Blind, Placebo-controlled Crossover Study of Tolerability and Efficacy of Cannabidiol (CBD) on Tremor in Parkinson's DiseaseParkinson's DiseaseDrug: cannabidiolUniversity of Colorado, DenverColorado Department of Public Health and Environment;GW Research LtdCompleted40 Years80 YearsAll13Phase 2United States
228NCT02940912
(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
229NCT02782481
(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
230NCT02382198
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2015-003512-20-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
232EUCTR2015-004912-39-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
233EUCTR2015-003512-20-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
234NCT02642393
(ClinicalTrials.gov)
June 201619/12/2015Study of Urate Elevation in Parkinson's Disease, Phase 3A Randomized, Double-blind, Placebo-controlled Trial of Urate-elevating Inosine Treatment to Slow Clinical Decline in Early Parkinson's DiseaseParkinson's DiseaseDrug: Inosine;Drug: PlaceboMichael Alan SchwarzschildThe Parkinson Study Group;Michael J. Fox Foundation for Parkinson's Research;University of Rochester;National Institute of Neurological Disorders and Stroke (NINDS)Completed30 YearsN/AAll298Phase 3United States;Puerto Rico
235NCT02785978
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2016-000679-25-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
237EUCTR2015-003512-20-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
238EUCTR2016-000636-18-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
239JPRN-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
240JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2015-003512-20-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
242EUCTR2015-003512-20-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
243EUCTR2015-003512-20-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
244EUCTR2014-005630-60-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
245EUCTR2015-005067-17-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
246NCT02729714
(ClinicalTrials.gov)
April 201626/1/2016A Pilot Study of Suvorexant for Insomnia in Parkinson DiseaseA Randomized, Double-Blind, Placebo-Controlled Pilot Study of Suvorexant for Insomnia in Parkinson DiseaseInsomniaDrug: Suvorexant;Drug: PlaceboBurdick, Daniel, M.D.Merck Sharp & Dohme Corp.Recruiting30 Years80 YearsAll20Phase 4United States
247NCT02775591
(ClinicalTrials.gov)
April 20169/5/2016Effect of Short-term Motilitone Therapy on Health-related Quality of Life in PD Patients With Gastrointestinal SymptomsEffect of Short-term Motilitone Therapy on Health-related Quality of Life in Parkinson's Disease Patients With Gastrointestinal Symptoms: a Multicenter, Double-blind Randomized, Placebo-controlled TrialParkinson Disease;DyspepsiaDrug: DA-9701;Drug: DA-9701 placeboSeoul National University HospitalSamsung Medical Center;Korea University Guro Hospital;Hanyang University;Seoul Veterans Hospital;SMG-SNU Boramae Medical CenterCompleted50 Years80 YearsAll147Phase 4Korea, Republic of
248JPRN-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
249EUCTR2015-003679-31-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
250NCT02787590
(ClinicalTrials.gov)
March 21, 201626/5/2016Simvastatin as a Neuroprotective Treatment for Moderate Parkinson's DiseaseSimvastatin as a Neuroprotective Treatment for Parkinson's Disease: a Double-blind, Randomised, Placebo Controlled Futility Study in Patients of Moderate Severity.Parkinson DiseaseDrug: Simvastatin;Drug: Matched Placebo (for Simvastatin)University Hospital Plymouth NHS TrustUniversity of PlymouthActive, not recruiting40 Years90 YearsAll235Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2015-005067-17-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
252NCT02687542
(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
253NCT02708186
(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
254NCT02605434
(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
255NCT02618941
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256JPRN-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
257NCT02683629
(ClinicalTrials.gov)
February 20168/2/2016Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's DiseaseA Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's DiseaseParkinson's DiseaseBiological: NTCELL Implantation;Other: Sham SurgeryLiving Cell TechnologiesStatistecol Consultants LimitedCompleted40 Years65 YearsAll18Phase 2New Zealand
258NCT02680977
(ClinicalTrials.gov)
February 20169/2/2016Mucuna Pruriens Therapy in Parkinson's DiseaseMucuna Pruriens Therapy in Parkinson's Disease: a Double-blind, Placebo-controlled, Randomized, Crossover Study.Parkinson's DiseaseOther: MP-Equivalent;Other: MP-Low;Other: MP+DDCI;Drug: LD+DDCI;Drug: LD-DDCI;Other: PlaceboASST Gaetano Pini-CTOFondazione Grigioni per il Morbo di Parkinson;Fondazione Grigioni per il Morbo di ParkinsonCompleted21 YearsN/ABoth18Phase 2Bolivia
259NCT02641054
(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
260NCT02655315
(ClinicalTrials.gov)
February 20167/1/2016Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's DiseaseConservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease. European Multicentre, Parallel-group, Placebo-controlled, Randomized Clinical Trial of DeferiproneParkinson DiseaseDrug: Deferiprone;Drug: PlaceboUniversity Hospital, LilleEuropean Commission;ApoPharmaActive, not recruitingN/A80 YearsAll372Phase 2Austria;Czechia;France;Germany;Netherlands;Portugal;Spain;United Kingdom;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261JPRN-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
262NCT03258294
(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
263ChiCTR-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
264NCT02768077
(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
265NCT02639221
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266EUCTR2014-002600-24-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
267JPRN-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
268EUCTR2014-002600-24-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
269EUCTR2014-005630-60-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
270EUCTR2014-002600-24-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
271JPRN-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
272EUCTR2014-002600-24-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
273JPRN-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
274EUCTR2015-000148-40-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
275JPRN-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
276EUCTR2014-002600-24-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
277NCT02758730
(ClinicalTrials.gov)
November 201526/4/2016Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A in PD-GBA PatientsA Randomized, Placebo-controlled, Parallel Group, Patient-blind, Single-center Phase I Pilot Study Assessing Tolerability and Safety and Exploring the Immunogenicity and Therapeutic Activity of AFFITOPE® PD01A, a New Vaccine Against Alpha-synuclein, in Patients With PD-GBAParkinson's DiseaseBiological: AFFITOPE® PD01A + Adjuvant;Biological: Adjuvant without active componentAffiris AGUniversity Hospital TuebingenWithdrawn40 Years80 YearsBoth0Phase 1Germany
278EUCTR2014-005630-60-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
279EUCTR2014-005630-60-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
280EUCTR2015-000373-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT02488265
(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
282NCT02459886
(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
283NCT02453386
(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
284NCT02469090
(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
285EUCTR2014-003799-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2010-024424-26-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
287NCT02439203
(ClinicalTrials.gov)
May 201530/4/2015Efficacy and Safety of JM-010 in PD With Levodopa-Induced DyskinesiaA Randomized, Double-blind, Placebo-controlled, 2-way Crossover Study in Subjects With Parkinson's Disease With Moderate to Severe Levodopa-induced Dyskinesia, to Assess the Efficacy, Safety/Tolerability and Pharmacokinetics of JM-010Parkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: JM-010;Drug: PlaceboBukwang PharmaceuticalContera Pharma ApSCompleted18 YearsN/ABoth30Phase 2South Africa
288NCT02439125
(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
289EUCTR2014-003799-22-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
290JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2014-003799-22-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
292NCT02352363
(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
293NCT02373072
(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
294NCT02066571
(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
295EUCTR2014-003799-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2014-003799-22-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
297NCT02337725
(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
298EUCTR2014-003799-22-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
299NCT02339064
(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
300NCT02337738
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2014-003799-22-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
302EUCTR2014-004501-32-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
303NCT02267434
(ClinicalTrials.gov)
December 20144/9/2014Study Assessing Tolerability and Safety of AFFITOPE® PD03A in Patients With Early Parkinson's DiseaseA Randomized, Placebo-controlled, Parallel Group, Patient-blinded, Multi-center, Phase I Pilot Study to Assess Tolerability and Safety of Two Doses of AFFITOPE® PD03A Formulated With Adjuvant to Patients With Early Parkinson's DiseaseParkinson Disease;Neurodegenerative DiseasesBiological: Low dose AFFITOPE® PD03A + Adjuvant;Biological: High dose AFFITOPE® PD03A + Adjuvant;Biological: Adjuvant without active componentAffiris AGPROSENEX AmbulatoriumbetriebsGMBH;Medical University Innsbruck;Forschungszentrum JuelichCompleted45 Years70 YearsBoth36Phase 1Austria
304EUCTR2014-001132-10-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
305JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306NCT02168842
(ClinicalTrials.gov)
November 201418/6/2014Efficacy of Isradipine in Early Parkinson DiseasePhase 3 Double-blind Placebo-controlled Parallel Group Study of Isradipine as a Disease Modifying Agent in Subjects With Early Parkinson DiseaseParkinson DiseaseDrug: Isradipine;Drug: Placebo (for Isradipine)University of RochesterNational Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's Research;The Parkinson Study GroupCompleted30 YearsN/AAll336Phase 3United States;Canada
307NCT02240030
(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
308EUCTR2014-000335-17-GB
(EUCTR)
28/10/201423/07/2014Rotigotine and memory in Parkinson's.The Effect of Rotigotine on Memory in Idiopathic Parkinson's Disease without Cognitive Impairment - Rotigotine and Memory in Parkinson's. Idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: rotigotine
INN or Proposed INN: Rotigotine
Product Name: levodopa CR (controlled release)
INN or Proposed INN: levodopa
Product Name: Rasagiline
INN or Proposed INN: Rasagiline
Product Name: Selegiline
INN or Proposed INN: selegiline
Research and Development University Hospital of North StaffordshireKeele UniversityNot RecruitingFemale: yes
Male: yes
0United Kingdom
309EUCTR2014-001132-10-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
310EUCTR2014-001131-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT02153645
(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
312NCT02216188
(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
313NCT02153632
(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
314NCT02472210
(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
315EUCTR2013-000980-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316NCT02157714
(ClinicalTrials.gov)
June 20144/6/2014Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: PRX002;Other: PlaceboProthena Biosciences LimitedHoffmann-La RocheCompleted40 Years80 YearsBoth64Phase 1United States
317NCT01971242
(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
318NCT02046447
(ClinicalTrials.gov)
May 201423/1/2014Neuroimaging of DystoniaNeuroimaging of Dystonia: The Bachmann-Strauss Dystonia and Parkinson Disease Center of Excellence at the University of FloridaPrimary Cervical Dystonia;DYT 1 DystoniaDrug: Primary Cervical Dystonia (Trihexyphenidyl);Other: Controls Primary Cervical Dystonia (Trihexyphenidyl);Other: DYT 1 Dystonia (Healthy Control);Other: DYT 1 DystoniaUniversity of FloridaBachmann Strauss Dystonia & Parkinson Foundation, Inc.Completed7 Years70 YearsAll20N/AUnited States
319EUCTR2012-005539-10-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
320EUCTR2013-002254-70-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2013-003363-64-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
322NCT02091739
(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
323NCT02111122
(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
324EUCTR2013-002254-70-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
325EUCTR2013-000980-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326NCT02006121
(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
327NCT02006290
(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
328NCT02111330
(ClinicalTrials.gov)
March 201420/3/2014Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy VolunteersRandomized, Double Blind, Placebo Controlled, Parallel Groups Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of PBF -509 (80 mg, 160 mg and 240 mg) After Multiple Oral Doses in Healthy VolunteersParkinson DiseaseDrug: PBF-509;Drug: PlaceboFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPalo Biofarma, S.LCompleted18 Years45 YearsBoth16Phase 1Spain
329NCT02095171
(ClinicalTrials.gov)
March 201414/3/2014Single Ascending Dose Study of PRX002 in Healthy SubjectsA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy SubjectsParkinson's DiseaseDrug: PRX002;Other: PlaceboProthena Biosciences LimitedHoffmann-La RocheCompleted21 Years65 YearsBoth40Phase 1United States
330EUCTR2013-002254-70-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
331EUCTR2013-002254-70-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
332EUCTR2013-000980-10-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
333EUCTR2013-000980-10-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
334NCT02064166
(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
335NCT02108704
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT01883505
(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
337NCT01968460
(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
338EUCTR2012-002840-26-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
339NCT01856738
(ClinicalTrials.gov)
November 201314/5/2013Cholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson&Apos;s DiseaseCholinesterase Inhibitors to Slow Progression of Visual Hallucinations in Parkinson's Disease:a Multi-center Placebo-controlled Trial.Parkinson's DiseaseDrug: Rivastigmine;Drug: Placebo (for rivastigmine)VU University Medical CenterAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA);Atrium Medical Center;University Medical Center Groningen;Leiden University Medical Center;University Medical Center Nijmegen;International Parkinson Fonds Germany GmbH;ZonMw: The Netherlands Organisation for Health Research and DevelopmentTerminated40 YearsN/AAll91Phase 4Netherlands
340EUCTR2011-004438-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2013-000980-10-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
342NCT01960842
(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
343NCT01968031
(ClinicalTrials.gov)
October 201318/10/2013A 12-week Randomized Study to Evaluate Oral Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseA Phase 3, 12-week, Double-Blind, Placebo-Controlled, Randomized, Multicenter Study to Evaluate the Efficacy of Oral Istradefylline 20 and 40 mg/Day as Treatment for Subjects With Moderate to Severe Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: Istradefylline 40 mg;Drug: Istradefylline 20 mg;Drug: PlaceboKyowa Hakko Kirin Pharma, Inc.Kyowa Kirin Co., Ltd.Completed30 YearsN/AAll613Phase 3United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic
344NCT01955616
(ClinicalTrials.gov)
September 201325/9/2013A Phase 2 Study to Evaluate the Safety and Efficacy of RM-131 in Patients With Parkinson's Disease & Chronic ConstipationA Phase 2, Randomized, Double-blind, Placebo-controlled, Multiple Dose, Parallel Group Study to Evaluate the Pharmacodynamics, Efficacy and Safety of RM-131 Administered to Patients With Parkinson's Disease and Chronic Constipation Dissatisfied With Current TherapyParkinson's DiseaseDrug: RM-131;Drug: PlaceboMotus Therapeutics, Inc.Michael J. Fox Foundation for Parkinson's ResearchTerminated18 Years80 YearsBoth18Phase 2United States
345NCT01929317
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346EUCTR2013-001722-25-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
347EUCTR2011-004438-32-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
348NCT01767129
(ClinicalTrials.gov)
July 20139/1/2013Safety and Efficacy of AVP-923 in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease PatientsA Phase 2a, Double-blind, Randomized, Placebo-controlled, Crossover Study to Evaluate the Safety and Efficacy of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Levodopa-induced Dyskinesia in Parkinson's Disease Patients.Dyskinesia;Parkinson's DiseaseDrug: AVP-923-45;Drug: PlaceboAvanir PharmaceuticalsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 Years80 YearsAll14Phase 2United States;Canada
349JPRN-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
350NCT01879748
(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
351NCT01765257
(ClinicalTrials.gov)
June 20138/1/2013Evaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center StudyEvaluation of the Efficacy of Rasagiline in Apathy in Drug-naïve Patients With Parkinson's Disease by a Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled Study.Drug-naïve Patients With Parkinson's Disease;ApathyDrug: AZILECT®;Drug: PlaceboUniversity Hospital, Clermont-FerrandH. Lundbeck A/S, TEVA;CHU Purpan (Toulouse);Hôpital Haut-Levêque (Pessac);Centre Hospitalier de la Côte Basque;Centre Hospitalier Universitaire de Poitiers (Poitiers);CHU de Rennes (Rennes);University Hospital, Lille;CHU Dupuytren (Limoges);University Hospital, Caen;Hôpital Caremeau (NIMES);Centre Hospitalier Pays D'Aix;Hôpital de la Timone (MARSEILLE);University Hospital, Rouen;Centre Hospitalier Universitaire, Amiens;Centre Hospitalier Universitaire de Saint Etienne;Fondation Rothschild ParisNot yet recruiting30 Years70 YearsBoth50Phase 4France
352NCT01850381
(ClinicalTrials.gov)
June 20137/5/2013Phase 2A Study of GM 608 in Mild to Moderate Parkinson DiseaseGM 608 in A Phase IIA Pilot Double-blinded, Randomized, Placebo Controlled Trial in Mild to Moderate Parkinson DiseaseParkinson's DiseaseDrug: GM608;Drug: Placebo ComparatorGenervon Biopharmaceuticals, LLCColumbia UniversityCompleted30 YearsN/AAll6Phase 2United States
353EUCTR2012-005822-31-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
354NCT03022201
(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
355NCT02473562
(ClinicalTrials.gov)
May 201312/6/2015Varenicline Treatment for Excessive Daytime Sleepiness in Parkinson's DiseaseVarenicline, a Partial Nicotinic Receptor Agonist for the Treatment of Excessive Daytime Sleepiness in Parkinson's Disease: a Placebo-controlled Cross-over Pilot StudyParkinson's DiseaseDrug: Varenicline;Drug: Placebo (for varenicline)VU University Medical CenterCentre for Human Drug Research, NetherlandsTerminatedN/AN/AAll22Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356EUCTR2012-002840-26-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
357EUCTR2012-005822-31-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
358EUCTR2012-002608-42-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
359NCT01777555
(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
360EUCTR2012-002840-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361NCT04627155
(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
362EUCTR2012-002840-26-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
363JPRN-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
364EUCTR2012-002840-26-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
365EUCTR2012-002840-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366NCT01782222
(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
367NCT01766128
(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
368EUCTR2012-002840-26-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
369EUCTR2012-002608-42-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
370EUCTR2012-002608-42-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371EUCTR2012-002840-26-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
372NCT02100176
(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
373EUCTR2012-002608-42-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
374NCT01725802
(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
375NCT01741701
(ClinicalTrials.gov)
December 20121/12/2012A Pilot Study of Oxaloacetate in Subjects With Treated PDA Pilot Double-Blind, Parallel Group, Placebo Controlled Study of Oxaloacetate in Subjects With Treated Parkinson's Disease (PD)Parkinson's DiseaseDrug: Oxaloacetate (OAA);Drug: PlaceboUniversity of Kansas Medical CenterTerra Biological LLCCompleted30 YearsN/AAll33Phase 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
376NCT01744496
(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
377NCT01683253
(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
378NCT01723228
(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
379NCT03652363
(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
380NCT01603069
(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
381NCT01691924
(ClinicalTrials.gov)
October 201213/9/2012Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy VolunteersRandomized, Double Blind, Placebo Controlled First In-human Study To Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-509 in Male Healthy VolunteersParkinson DiseaseDrug: PBF-509;Drug: PlaceboFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPalo Biofarma, S.LCompleted18 Years45 YearsMale56Phase 1Spain
382NCT01560754
(ClinicalTrials.gov)
October 20129/3/2012Disease-modifying Potential of Transdermal NICotine in Early Parkinson's DiseaseA 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 USAParkinson's DiseaseDrug: nicotine transdermal patchJames BOYD MDMichael J. Fox Foundation for Parkinson's Research;Parkinson Study Group (PSG);International Parkinson Fonds (IPF);German Parkinson Study Group (GPS);German Parkinson Society (DPG);Philipps-University Marburg, GermanyActive, not recruiting30 YearsN/ABoth160Phase 2United States;Germany
383EUCTR2011-003866-34-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
384EUCTR2011-004803-19-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
385EUCTR2012-001530-34-NL
(EUCTR)
09/08/201209/08/2012Vareniciline treatment for Excessive Daytime Sleepiness in Parkinson’s DiseaseVarenicline, a partial nicotinic receptor agonist for the treatment of Excessive Daytime Sleepiness in Parkinson’s Disease: a placebo-controlled cross-over study - Vareniciline for Excessive daytime Sleepiness in PArkinson’s disease (VESPA) 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: Champix
INN or Proposed INN: VARENICLINE
Other descriptive name: VARENICLINE TARTRATE
VU University Medical CenterCenter Human Drug ResearchNot RecruitingFemale: yes
Male: yes
32Phase 3Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386NCT01602549
(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
387NCT01646255
(ClinicalTrials.gov)
July 201218/7/2012Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease PatientsA Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of The Efficacy And Safety of Rotigotine Transdermal Patch In Chinese Subjects With Advanced-stage, Idiopathic Parkinson's Disease Who Are Not Well Controlled On LevodopaIdiopathic Parkinson's DiseaseDrug: Rotigotine;Drug: Placebo Patch;Drug: L-dopaUCB PharmaUCB Trading (Shanghai) Co. Ltd.Completed30 YearsN/AAll346Phase 3China
388NCT01646268
(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
389EUCTR2011-003053-25-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
390JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391JPRN-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
392EUCTR2011-002074-23-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
393NCT01993680
(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
394NCT02319382
(ClinicalTrials.gov)
June 201218/11/2014Measure of Microglial Activation in the Brain of Parkinson Disease Patients With PETHigh Resolution PET Imaging of Microglial Activation in Parkinson's Disease (PD) With a New Tracer [18F]DPA-714Parkinson's Disease With LRRK2 Mutation;Healthy Controls;Parkinson's Disease Without LRRK2 MutationRadiation: PET with the tracer 18F-DPA-714;Radiation: PET with the tracer 11C-PE2I;Other: MRIAssistance Publique - Hôpitaux de ParisFrance Parkinson AssociationRecruiting18 YearsN/ABoth46N/AFrance
395EUCTR2012-001218-40-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396NCT01617135
(ClinicalTrials.gov)
May 20127/5/2012Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and Off EpisodesA Randomized, Placebo-Controlled, Phase 2 Study of the Safety, Pharmacokinetics and Pharmacodynamics of CVT-310 (Levodopa Inhalation Powder) in Patients With Parkinson's Disease and Motor Response Fluctuations (Off Episodes)Idiopathic Parkinson's DiseaseDrug: CVT-301;Drug: Placebo;Drug: Sinemet (carbidopa/levodopa)Acorda TherapeuticsMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll25Phase 2Israel;Serbia;United Kingdom
397EUCTR2012-000181-37-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
398EUCTR2011-004438-32-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
399EUCTR2011-005839-91-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
400NCT01523301
(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
401NCT01491529
(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
402NCT01527695
(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
403NCT01331122
(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
404NCT01486628
(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
405NCT01556165
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406EUCTR2011-002074-23-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
407EUCTR2011-002074-23-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
408EUCTR2011-002074-23-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
409EUCTR2011-002074-23-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
410EUCTR2011-002074-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411EUCTR2011-002901-31-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
412NCT01653132
(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
413NCT01565395
(ClinicalTrials.gov)
March 201226/3/2012Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Parkinson Disease;Amyotrophic Lateral SclerosisDrug: Incobotulinum Toxin A;Drug: placeboBeth Israel Deaconess Medical CenterMerz PharmaceuticalsWithdrawn20 Years80 YearsAll0Phase 2United States
414NCT01519882
(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
415NCT01538329
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416EUCTR2011-004803-19-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
417EUCTR2011-005054-59-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
418NCT01568099
(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
419NCT01497652
(ClinicalTrials.gov)
January 201220/12/2011A Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic TherapyA Double Blind Placebo Controlled Trial Evaluating Rasagiline Effects on Cognition in Parkinson's Disease Patients With Mild Cognitive Impairment Receiving Dopaminergic TherapyParkinson's DiseaseDrug: Rasagiline/Placebo;Drug: RasagilineGeorgetown UniversityTeva Neuroscience, Inc.Completed40 YearsN/ABoth34Phase 4United States
420NCT01536015
(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
421EUCTR2011-002901-31-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
422EUCTR2009-017412-32-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
423EUCTR2011-002901-31-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
424NCT01351168
(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
425NCT01479530
(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
426NCT01519271
(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
427NCT01521117
(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
428EUCTR2011-002901-31-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
429EUCTR2011-002901-31-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
430EUCTR2009-015162-57-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431EUCTR2011-002073-30-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
432EUCTR2009-015162-57-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
433NCT01385592
(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
434NCT01736891
(ClinicalTrials.gov)
November 201127/11/2012Clinical Trial of Rasagiline in Levodopa-Treated Parkinson's Disease Patients With Motor FluctuationsEvaluation for the Efficacy,Tolerability,and Safety of Rasagiline in Levodopa-treated PD Patients With Motor Fluctuations: A Multicenter, Double Blind, Randomized, Placebo-Controlled Group Study (China)Parkinson´s DiseaseDrug: Rasagiline;Drug: PlaceboChongqing Fortune Pharmaceutical Co., Ltd.Beijing Bionovo Medicine Development Co., Ltd.Completed30 Years75 YearsBoth268Phase 3China
435NCT01457807
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436EUCTR2009-015162-57-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
437EUCTR2011-000056-42-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
438NCT01479127
(ClinicalTrials.gov)
October 201126/9/2011Study 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 DiseaseAdvanced Parkinson's DiseaseDrug: ABT-SLV187;Drug: Oral Levodopa/Carbidopa;Device: Infusion Pump: CADD-Legacy® 1400 Pump;Device: NJ-Tube: Silicon ED Tube;Device: Adaptor: Hakko AdaptorAbbVie (prior sponsor, Abbott)Abbott Japan Co.,LtdCompleted30 Years99 YearsAll8Phase 2Japan
439NCT01439100
(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
440EUCTR2010-018534-44-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441EUCTR2009-015162-57-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
442NCT01474421
(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
443NCT01178047
(ClinicalTrials.gov)
September 20116/8/2010Multicenter Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's DiseaseA Multicenter, Randomized, Double-blind Placebo Controlled Study to Assess the Effect of Rasagiline on Sleep-wake Disturbances in Patients With Parkinson's Disease (PD)Parkinson's DiseaseDrug: RasagilineUniversity of ZurichH. Lundbeck A/STerminated40 YearsN/ABoth1Phase 4Switzerland
444EUCTR2010-018534-44-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
445EUCTR2010-020299-42-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446EUCTR2009-015162-57-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
447EUCTR2010-021860-13-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
448EUCTR2009-015162-57-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
449EUCTR2010-021394-37-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
450NCT01370811
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT01634568
(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
452NCT01461109
(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
453NCT01437189
(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
454EUCTR2009-015162-57-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
455EUCTR2010-021860-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456EUCTR2009-015162-57-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
457EUCTR2009-015162-57-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
458EUCTR2011-001092-39-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
459EUCTR2010-020112-11-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
460EUCTR2010-021860-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461EUCTR2010-020112-11-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
462EUCTR2009-015162-57-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
463EUCTR2009-015161-31-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
464EUCTR2009-013552-72-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
465NCT02253563
(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
466EUCTR2010-022517-25-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
467EUCTR2009-015162-57-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
468EUCTR2010-021394-37-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
469EUCTR2007-002964-90-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
470EUCTR2010-021394-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471NCT01520987
(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
472NCT01462708
(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
473EUCTR2010-022366-27-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
474EUCTR2010-022366-27-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
475EUCTR2010-022517-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476EUCTR2009-015161-31-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
477JPRN-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
478NCT01313819
(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
479NCT01336088
(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
480EUCTR2009-013552-72-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
481EUCTR2010-022366-27-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
482EUCTR2009-015162-57-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
483EUCTR2010-018534-44-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
484EUCTR2010-021860-13-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
485EUCTR2010-021394-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486EUCTR2010-021394-37-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
487EUCTR2009-015161-31-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
488EUCTR2009-013552-72-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
489EUCTR2009-015162-57-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
490EUCTR2010-021394-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
491NCT01227655
(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
492NCT01280123
(ClinicalTrials.gov)
March 20113/12/2010Pioglitazone in Early Parkinson's DiseaseA Multi-Center, Double-Blind, Placebo-Controlled Phase II Study of Pioglitazone in Early Parkinson's DiseaseParkinson's DiseaseDrug: Pioglitazone;Drug: placeboUniversity of RochesterNational Institute of Neurological Disorders and Stroke (NINDS);Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll210Phase 2United States
493NCT01283594
(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
494NCT01568073
(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
495NCT01294800
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
496EUCTR2010-022363-35-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
497EUCTR2009-015161-31-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
498EUCTR2010-021860-13-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
499EUCTR2010-021394-37-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
500EUCTR2010-021394-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501EUCTR2009-017174-20-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
502NCT01300819
(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
503NCT01313845
(ClinicalTrials.gov)
February 201110/3/2011Effect of Intravenous Amantadine on Gait Freezing in Parkinson's DiseaseRandomized Double-blind Placebo-controlled Trial of Intravenous Amantadine on Gait Freezing in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: amantadine sulfate;Drug: 0.9% sodium chlorideJee-Young LeeSeoul National University Boramae Hospital;Samsung Medical Center;Seoul National University Bundang Hospital;Hanyang UniversityCompleted30 Years79 YearsBoth46Phase 4Korea, Republic of
504EUCTR2009-015161-31-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
505EUCTR2010-021860-13-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
506EUCTR2010-021860-13-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
507EUCTR2010-021394-37-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
508EUCTR2010-021860-13-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
509EUCTR2009-015161-31-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
510EUCTR2009-013552-72-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511NCT01268891
(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
512NCT01229332
(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
513EUCTR2010-021860-13-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
514EUCTR2010-021860-13-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
515EUCTR2008-004146-88-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516EUCTR2010-022366-27-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
517EUCTR2009-015161-31-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
518EUCTR2009-013552-72-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
519EUCTR2009-015161-31-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
520EUCTR2009-013552-72-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521EUCTR2009-015161-31-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
522NCT01244269
(ClinicalTrials.gov)
December 201018/11/2010The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease.Two-phase Randomized Controlled Trial of Low and Moderate Dose Methylphenidate for Non-motor and Postural Symptoms in Parkinson's Disease.Parkinson's DiseaseDrug: Methylphenidate;Drug: Placebo 10;Drug: Placebo 20Laval UniversityFonds de la Recherche en Santé du Québec;Quebec Memory and Motor Skills Disorders Research CenterTerminatedN/A75 YearsBoth6Phase 4Canada
523EUCTR2010-021860-13-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
524EUCTR2010-020109-34-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
525EUCTR2010-020109-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526NCT01227265
(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
527NCT01215227
(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
528EUCTR2010-021860-13-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
529EUCTR2009-015161-31-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
530NCT01060878
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531EUCTR2009-013552-72-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
532EUCTR2010-018534-44-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
533EUCTR2009-013552-72-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
534EUCTR2009-015161-31-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
535EUCTR2009-015928-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536EUCTR2007-002964-90-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
537EUCTR2009-013552-72-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
538NCT01211587
(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
539EUCTR2009-015161-31-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
540NCT01155466
(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
541NCT01155479
(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
542NCT01174810
(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
543NCT01174004
(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
544EUCTR2009-013886-24-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
545NCT01176240
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546NCT01227681
(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
547NCT01140841
(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
548EUCTR2010-019396-29-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
549NCT01532115
(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
550EUCTR2009-018137-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551NCT01103011
(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
552NCT01113320
(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
553EUCTR2009-017174-20-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
554EUCTR2009-013886-24-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
555NCT01092065
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556NCT01066442
(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
557NCT01055379
(ClinicalTrials.gov)
March 201022/1/2010Rasagiline in Cognitive-impairment Related Depression: AzileCt in COgnitive-impairment Related DepressiOnA Randomised, Double-blind, Placebo-controlled Study to Evaluate if Rasagiline Can Improve Depressive Symptoms and Cognitive Function in Non-demented, Idiopathic Parkinson's Disease Patients: ACCORDO StudyDepressive Symptoms;Parkinson's DiseaseDrug: Rasagiline;Drug: PlaceboLundbeck Italia S.p.A.Teva Pharmaceutical IndustriesCompleted40 Years80 YearsAll121Phase 4Italy
558EUCTR2009-017174-20-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
559EUCTR2007-002963-28-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
560NCT01154166
(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
561NCT01568047
(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
562NCT01058291
(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
563NCT01018264
(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
564NCT01417598
(ClinicalTrials.gov)
January 201015/8/2011BETA Study: Improving Balance Function in Elderly by Progressive and Specific Training and Physical ActivityImproving Balance Function in Elderly by Progressive and Specific Training and Physical Activity- a Randomized Controlled Study.Elderly;Parkinsons Disease;OsteoporosisOther: Gait and balance group training;Other: Nordic walking (only osteoporosis group)Karolinska InstitutetThe Swedish Research CouncilActive, not recruiting60 YearsN/AAll200N/ASweden
565EUCTR2009-012897-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
566NCT01036139
(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
567NCT01168596
(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
568NCT01049984
(ClinicalTrials.gov)
December 200913/1/2010Rasagiline as Add on to Dopamine Agonists in the Treatment of Parkinson's DiseaseA Double-blind, Placebo Controlled, Randomized, Multicenter Study to Assess the Safety and Clinical Benefit of Rasagiline as an Add on Therapy to Stable Dose of Dopamine Agonists in the Treatment of Early Parkinson's DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboTeva Neuroscience, Inc.H. Lundbeck A/SCompleted30 YearsN/AAll328Phase 4United States
569NCT01070628
(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
570EUCTR2009-013886-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
571EUCTR2009-013885-14-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
572EUCTR2009-013885-14-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
573NCT01052831
(ClinicalTrials.gov)
November 200915/1/2010Naltrexone for Impulse Control Disorders in Parkinson's DiseaseRandomized, Double-blind, Placebo-controlled Study of Naltrexone for Impulse Control Disorders in Parkinson's DiseaseImpulse Control Disorder;Parkinson DiseaseDrug: Naltrexone;Drug: PlaceboUniversity of PennsylvaniaMichael J. Fox Foundation for Parkinson's ResearchCompleted18 Years85 YearsAll50Phase 4United States
574NCT01519284
(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
575NCT01007630
(ClinicalTrials.gov)
November 20093/11/2009A Study Assessing Change in Sense of Smell After Rasagiline Use in Parkinson's PatientsA Prospective Randomized Placebo-Controlled Double-Blind Study Assessing Change in Olfactory Function After Initiation of Rasagiline in Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: Rasagiline;Drug: PlaceboThe Parkinson's InstituteTeva Neuroscience, Inc.Active, not recruitingN/A90 YearsBoth36Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
576NCT01023282
(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
577EUCTR2008-004146-88-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
578NCT00957918
(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
579NCT01108029
(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
580NCT01028586
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581NCT00914095
(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
582ChiCTR-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
583NCT01026428
(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
584NCT00903838
(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
585NCT00986414
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586EUCTR2008-004146-88-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
587EUCTR2008-008712-98-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
588EUCTR2008-004146-88-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
589NCT00918177
(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
590NCT00970229
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591NCT00955526
(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
592NCT00909545
(ClinicalTrials.gov)
July 200926/5/2009Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson DiseaseA Pilot Phase II Double-Blind, Placebo-Controlled, Tolerability and Dosage Finding Study of Isradipine CR as a Disease Modifying Agent in Patients With Early Parkinson DiseaseParkinson DiseaseDrug: Isradipine CR 5mg;Drug: Isradipine CR 10mg;Drug: Isradipine CR 20mg;Drug: PlaceboNorthwestern UniversityMichael J. Fox Foundation for Parkinson's Research;Northwestern University Dixon Fund;The Parkinson Study GroupCompleted30 YearsN/AAll99Phase 2United States;Canada
593EUCTR2008-004146-88-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
594EUCTR2008-001966-10-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
595EUCTR2009-012529-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596EUCTR2008-008712-98-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
597EUCTR2008-004146-88-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
598EUCTR2009-010193-38-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
599EUCTR2009-010193-38-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
600NCT00833690
(ClinicalTrials.gov)
June 200927/1/2009Safety of Urate Elevation in Parkinson's DiseaseA Randomized, Double-blind, Placebo-controlled, Dose-ranging Trial of Oral Inosine to Assess Safety and Ability to Elevate Urate in Early Parkinson's DiseaseParkinson DiseaseDrug: Placebo;Drug: inosineThe Parkinson Study GroupMassachusetts General Hospital;Harvard School of Public Health;University of Rochester;Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll75Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601NCT01628926
(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
602EUCTR2008-001966-10-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
603EUCTR2008-004146-88-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
604EUCTR2008-004146-88-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
605EUCTR2008-001966-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606EUCTR2008-004146-88-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
607EUCTR2008-008712-98-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
608EUCTR2008-008712-98-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
609EUCTR2008-001966-10-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
610EUCTR2008-000400-81-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611EUCTR2009-010193-38-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
612EUCTR2008-001966-10-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
613EUCTR2007-002963-28-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
614NCT00907595
(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
615EUCTR2008-002769-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
616EUCTR2007-001095-36-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
617EUCTR2008-000400-81-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
618EUCTR2007-002963-28-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
619EUCTR2007-002964-90-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
620JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621NCT00880620
(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
622NCT01568034
(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
623NCT00875316
(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
624EUCTR2008-000400-81-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
625EUCTR2008-004447-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626EUCTR2007-002963-28-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
627EUCTR2007-002964-90-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
628NCT00767091
(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
629NCT00866502
(ClinicalTrials.gov)
March 200918/3/2009A Safety and Tolerability Study of Intracerebroventricular Administration of sNN0031 to Patients With Parkinson's DiseaseA 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.Parkinson's DiseaseDrug: sNN0031;Drug: PlaceboNewron Sweden ABMedtronic;QuintilesCompleted30 Years75 YearsBoth12Phase 1;Phase 2Sweden
630NCT00888004
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
631NCT01399905
(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
632NCT00627640
(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
633NCT00873392
(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
634NCT00908076
(ClinicalTrials.gov)
February 200921/5/2009Amitiza in Constipation Associated With PD (Parkinson's Disease)Randomized Double-Blind Placebo-Controlled Trial of Lubiprostone in the Treatment of Constipation Associated With Parkinson's DiseaseParkinson's DiseaseDrug: LUBIPROSTONEBaylor College of MedicineUniversity of South FloridaCompleted18 Years85 YearsAll78Phase 4United States
635NCT00806468
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636EUCTR2007-007853-30-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
637EUCTR2009-015833-66-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
638EUCTR2007-002963-28-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
639NCT02169466
(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
640EUCTR2004-000148-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641EUCTR2008-003966-25-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
642NCT00809302
(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
643EUCTR2008-004943-12-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
644EUCTR2007-006721-27-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
645EUCTR2007-003051-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
646EUCTR2007-006721-27-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
647EUCTR2007-004890-24-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
648EUCTR2008-003869-72-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
649NCT00611481
(ClinicalTrials.gov)
October 20086/2/2008Study of Tai Chi Exercise and Balance in Persons With Parkinson's DiseasePhase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's DiseaseParkinson's DiseaseBehavioral: Tai Chi;Behavioral: Strength training;Behavioral: Low-Impact Exercise ControlOregon Research InstituteNational Institute of Neurological Disorders and Stroke (NINDS)Completed40 Years85 YearsBoth195Phase 2United States
650NCT02169453
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
651EUCTR2007-003051-36-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
652EUCTR2007-003051-36-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
653NCT02169479
(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
654NCT02169895
(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
655NCT00755027
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
656NCT00758849
(ClinicalTrials.gov)
September 200824/9/2008Fipamezole in Neurogenic Orthostatic HypotensionA 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 DiseaseSymptomatic Neurogenic Orthostatic Hypotension (NOH);Parkinson's Disease;Multiple System AtrophyDrug: Placebo;Drug: FipamezoleJuvantia Pharma LtdSanthera PharmaceuticalsNot yet recruiting30 Years80 YearsBoth24Phase 2France;Portugal
657NCT00745277
(ClinicalTrials.gov)
August 20082/9/2008High and Low Dose Treatment of Carbidopa in Parkinson's DiseaseA Randomized Controlled Trial of Four Week Outpatient Treatment of Parkinson's Disease Comparing High and Low Dose Carbidopa.Parkinson's DiseaseDrug: Carbidopa-Levodopa;Drug: Carbidopa- LevodopaOregon Health and Science UniversityParkinson Disease Research, Education and Clinical Center at Portland VA Hospital;RJG Foundation;Oregon Clinical and Translational Research InstituteCompleted35 Years85 YearsBoth12Phase 2United States
658EUCTR2004-000148-26-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
659EUCTR2007-003051-36-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
660EUCTR2007-002963-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
661EUCTR2007-003051-36-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
662EUCTR2007-002964-90-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
663EUCTR2007-004009-93-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
664EUCTR2007-004890-24-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
665EUCTR2006-006752-35-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
666NCT01416818
(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
667EUCTR2007-002906-23-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
668NCT02071810
(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
669NCT00605553
(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
670EUCTR2006-003732-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
671EUCTR2007-001095-36-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
672EUCTR2007-002964-90-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
673NCT00607451
(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
674NCT00642356
(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
675NCT00761137
(ClinicalTrials.gov)
March 200825/9/2008Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease PatientsA Two-Phase, Double Blind, Placebo-Controlled, Randomized, Crossover Study of the Safety and Efficacy of Intra-Oral NH004 Films for the Short-Term Relief of Sialorrhea Symptoms in Parkinson's Disease PatientsSialorrhea Secondary to Parkinson's DiseaseDrug: 0.3 mg tropicamide;Drug: 1 mg tropicamide;Drug: 3 mg tropicamide;Drug: 0 mg tropicamideNeuroHealing Pharmaceuticals Inc.Michael J. Fox Foundation for Parkinson's ResearchCompleted50 Years80 YearsAll19Phase 2Argentina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
676EUCTR2007-002964-90-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
677EUCTR2007-002964-90-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
678EUCTR2007-002195-34-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
679EUCTR2007-002467-27-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
680EUCTR2006-006752-35-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
681EUCTR2007-002964-90-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
682EUCTR2007-002963-28-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
683NCT00562198
(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
684NCT00623324
(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
685NCT00612872
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
686EUCTR2006-003732-30-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
687EUCTR2007-004400-12-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
688EUCTR2004-000185-12-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
689EUCTR2007-002963-28-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
690EUCTR2007-002964-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
691EUCTR2007-002964-90-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
692EUCTR2007-002963-28-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
693EUCTR2007-002964-90-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
694NCT00526630
(ClinicalTrials.gov)
December 20075/9/2007Methylphenidate for the Treatment of Gait Impairment in Parkinson's DiseaseMethylphenidate for the Treatment of Gain Impairment in Parkinson's Disease: a Randomized Double-Blind, Placebo-Controlled, Cross-over StudyParkinson's Disease;Gait ImpairmentDrug: Methylphenidate (MPD);Drug: PlaceboUniversity of CincinnatiMichael J. Fox Foundation for Parkinson's ResearchCompleted35 Years85 YearsAll23Phase 4United States
695EUCTR2007-002906-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
696EUCTR2007-002496-14-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
697ChiCTR-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
698NCT01301651
(ClinicalTrials.gov)
November 200718/2/2011Effects of Virtual Reality Training in Patients With Parkinson's DiseaseEffects of Virtual Reality Augmented Balance Training for Postural Control in Patients With Parkinson's DiseaseParkinson's DiseaseBehavioral: balance trainingNational Taiwan University HospitalNational Science Council, TaiwanCompleted50 Years80 YearsBoth42Phase 1Taiwan
699NCT00605683
(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
700EUCTR2007-002906-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
701EUCTR2007-002900-16-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
702NCT00559871
(ClinicalTrials.gov)
October 200715/11/2007Safety and Efficacy Study of Fipamezole in Treatment of Motor Dysfunctions in Parkinson's DiseaseA Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose Response Study of the Efficacy, Safety and Tolerability of Fipamezole as an Oromucosal Fast Dissolving Tablet in the Treatment of Parkinson's Disease Patients.Parkinson's DiseaseDrug: fipamezoleJuvantia Pharma LtdSanthera PharmaceuticalsCompleted30 YearsN/ABoth180Phase 2United States;India
703NCT00582673
(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
704EUCTR2006-002937-20-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
705EUCTR2007-002899-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
706NCT00537485
(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
707EUCTR2007-000074-23-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
708NCT00442780
(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
709NCT01286935
(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
710EUCTR2006-006752-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
711NCT00522379
(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
712NCT00515437
(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
713EUCTR2006-006752-35-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
714EUCTR2007-000073-39-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
715EUCTR2006-000678-57-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
716EUCTR2007-000074-23-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
717EUCTR2007-000073-39-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
718EUCTR2007-000073-39-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
719EUCTR2007-000074-23-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
720EUCTR2006-005861-21-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
721JPRN-UMIN000000780
2007/06/0101/08/2007A randomized, double-blind, placebo-controlled, cross-over, multi-center study concerning the efficacy and safety of amantadine hydrochloride in treatment of dyskinesias in Parkinson's disease Parkinson's diseaseAn observation period (2 to 3 weeks)

An administration of amantadine hydrochloride (27 days)

A wash out period (15 days)

An administration of placebo (27 days)
An observation period (2 to 3 weeks)

An administration of placebo (27 days)

A wash out period (15 days)

An administration of amantadine hydrochloride (27 days)
Comprehensive clinical study group concerning diagnosis, treatment, and prevention of the neurological disordersMusashi Hospital, National Center of Neurology and Psychiatry, JapanEhime University HospitalComplete: follow-up complete20years-old75years-oldMale and Female60Not applicableJapan
722NCT00460954
(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
723NCT00696215
(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
724NCT00477672
(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
725EUCTR2007-000074-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
726EUCTR2007-000073-39-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
727EUCTR2007-000073-39-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
728EUCTR2007-000074-23-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
729EUCTR2006-006752-35-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
730EUCTR2007-000074-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
731EUCTR2007-000074-23-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
732EUCTR2006-006752-35-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
733EUCTR2007-000074-23-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
734NCT00477802
(ClinicalTrials.gov)
May 200722/5/2007Botulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's DiseaseBotulinum Toxin Type A (Botox) in the Management of Levodopa-Induced Peak-Dose Dyskinesias in Parkinson's Disease: A Double-Blind, Randomized, Placebo Controlled, Cross-Over Design StudyParkinson DiseaseBiological: Botulinum Toxin Type A;Biological: PlaceboUniversity of CincinnatiAllerganTerminated35 Years75 YearsBoth8Phase 4United States
735NCT00479401
(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
736NCT00474058
(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
737NCT00505843
(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
738NCT00489255
(ClinicalTrials.gov)
May 200720/6/2007Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and TreatmentA Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Trimethobenzamide (Tigan®) in the Control of Nausea and Vomiting During Initiation and Continued Treatment With Subcutaneous Apomorphine (Apokyn®) in Apomorphine-naïve Subjects With Parkinson's Disease Suffering From Acute Intermittent Off Episodes, With Phased Withdrawal of Subjects From Tigan® to PlaceboParkinson's DiseaseDrug: Tigan®;Drug: PlaceboIpsenINC Research LimitedCompleted18 YearsN/AAll117Phase 4United States
739EUCTR2006-002937-20-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
740EUCTR2007-000073-39-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
741EUCTR2006-006752-35-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
742NCT00466167
(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
743NCT00438607
(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
744EUCTR2006-002937-20-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
745NCT01693081
(ClinicalTrials.gov)
March 200721/9/2012Phase IIa Multicentre Study Investigating of VR040 in Parkinson's DiseaseA Clinic-Based, Phase IIa, Double-Blind, Placebo- Controlled, Ascending-Dose, Multicentre Study of Safety, Tolerability, Efficacy and Pharmacokinetics of VR040 in Parkinson's DiseaseParkinson's DiseaseDrug: VR040/Aspirair® inhaler;Drug: placeboSouth Glasgow University Hospitals NHS TrustVectura LimitedCompleted30 Years90 YearsBoth47Phase 2Serbia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
746NCT00455507
(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
747NCT00449865
(ClinicalTrials.gov)
March 200720/3/2007NET-PD LS-1 Creatine in Parkinson's DiseaseA Multicenter, Double-Blind, Parallel Group, Placebo Controlled Study of Creatine in Subjects With Treated Parkinson's Disease (PD) Long Term Study (LS-1)Parkinson's DiseaseDrug: creatine;Other: placeboUniversity of RochesterNational Institute of Neurological Disorders and Stroke (NINDS)TerminatedN/AN/AAll1741Phase 3United States;Canada
748NCT00451633
(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
749NCT00406588
(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
750EUCTR2005-002038-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
751EUCTR2006-005714-12-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
752EUCTR2006-005182-20-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
753EUCTR2006-005182-20-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
754EUCTR2006-003732-30-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
755EUCTR2006-000678-57-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
756NCT00855686
(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
757NCT01187966
(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
758EUCTR2006-000678-57-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
759EUCTR2006-000678-57-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
760EUCTR2006-005509-79-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
761EUCTR2006-003490-27-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
762EUCTR2006-005860-14-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
763EUCTR2006-002937-20-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
764EUCTR2006-002937-20-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
765EUCTR2006-005140-89-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
766EUCTR2006-002937-20-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
767EUCTR2005-002038-36-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
768NCT00853879
(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
769NCT01964573
(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
770EUCTR2005-002038-36-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
771NCT00406029
(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
772EUCTR2006-000678-57-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
773EUCTR2006-001793-24-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
774EUCTR2006-000678-57-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
775EUCTR2006-000678-57-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
776EUCTR2006-004582-33-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
777EUCTR2006-002937-20-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
778NCT00335166
(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
779NCT00360308
(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
780NCT00402233
(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
781NCT00400634
(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
782EUCTR2005-002038-36-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
783NCT00590122
(ClinicalTrials.gov)
October 200628/12/2007Parcopa Versus Carbidopa-Levodopa in a Single Dose Cross-Over Comparison StudyCOMPARISON OF ORALLY DISSOLVING LEVODOPA (PARCOPA®) TO CONVENTIONAL ORAL LEVODOPA: A SINGLE DOSE, DOUBLE-BLIND, PLACEBO CONTROLLED, CROSS-OVER TRIALParkinson's DiseaseDrug: Parcopa;Drug: carbidopa-levodopaBaylor College of MedicineUCB PharmaCompleted31 Years80 YearsBoth20Phase 4United States
784NCT03103399
(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
785EUCTR2005-002038-36-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
786EUCTR2005-005146-39-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
787EUCTR2006-000678-57-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
788EUCTR2005-004949-34-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
789EUCTR2005-001006-12-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
790EUCTR2005-005423-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
791EUCTR2005-006033-32-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
792EUCTR2005-004314-33-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
793EUCTR2005-004949-34-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
794EUCTR2006-000678-57-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
795NCT01628848
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
796NCT00368108
(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
797EUCTR2006-001793-24-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
798NCT03097211
(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
799NCT00408915
(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
800NCT00354133
(ClinicalTrials.gov)
July 200619/7/2006Controlled Trial With Deep Brain Stimulation in Patients With Early Parkinson's DiseaseThe Effect of Deep Brain Stimulation of the Subthalamic Nucleus (STN-DBS) on Quality of Life in Comparison to Best Medical Treatment in Patients With Complicated Parkinson's Disease and Preserved Psychosocial Competence (EARLYSTIM-study)Parkinson DiseaseDevice: Kinetra and Soletra (neurostimulator, Medtronic);Drug: Best Medical TreatmentGerman Parkinson Study Group (GPS)University Hospital Schleswig-Holstein;Assistance Publique - Hôpitaux de Paris;KKS NetzwerkActive, not recruiting18 Years60 YearsAll251Phase 4France;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
801EUCTR2005-004314-33-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
802NCT00331149
(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
803EUCTR2005-005423-34-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
804EUCTR2005-004949-34-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
805EUCTR2005-006033-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
806NCT00269516
(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
807EUCTR2005-004949-34-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
808EUCTR2005-004314-33-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
809EUCTR2005-005423-34-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
810EUCTR2005-004949-34-FI
(EUCTR)
17/05/200621/04/2006A 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 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 IngelheimBoehringer Ingelheim Finland KyAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Finland;Germany;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
811EUCTR2005-005423-34-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
812EUCTR2005-005423-34-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
813NCT00321854
(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
814NCT00324896
(ClinicalTrials.gov)
May 20069/5/2006Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of EszopicloneTreatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of EszopicloneParkinson's Disease;InsomniaDrug: eszopiclone;Other: placeboUniversity of Medicine and Dentistry of New JerseySunovionCompleted35 Years85 YearsAll30Phase 3United States
815NCT00291733
(ClinicalTrials.gov)
May 200614/2/2006Levetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's DiseaseLevetiracetam Administration for the Management of Levodopa-Induced Dyskinesias in Parkinson's Disease: A Double-Blind,Placebo-Controlled, Crossover TrialLevodopa Induced DyskinesiaDrug: Levetiracetam;Drug: Placebo1st Hospital of Social Security ServicesUCB PharmaActive, not recruiting30 Years80 YearsBoth50Phase 2Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
816NCT03094156
(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
817EUCTR2005-005423-34-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
818EUCTR2005-006033-32-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
819EUCTR2005-004949-34-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
820EUCTR2005-001006-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
821NCT00461942
(ClinicalTrials.gov)
April 200617/4/2007Efficacy and Safety of Green Tea Polyphenol in De Novo Parkinson's Disease PatientsA Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Neuroprotection Effect of Green Tea Polyphenol in De Novo Parkinson's Disease PatientsParkinson's DiseaseDrug: Green Tea Polyphenols (EGCG/ECG)Xuanwu Hospital, BeijingMinistry of Health, China;Michael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/ABoth480Phase 2China
822NCT00294554
(ClinicalTrials.gov)
April 200621/2/2006Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and DementiaDouble-Blind Placebo-Controlled Trial of Memantine for Treatment of Cognitive Impairment in Patients With Parkinson's Disease and DementiaParkinson's Disease;Cognitive Impairment;DementiaDrug: Memantine;Drug: Placebo Oral TabletJohns Hopkins UniversityForest LaboratoriesCompleted50 YearsN/AAll20N/AUnited States
823NCT00646204
(ClinicalTrials.gov)
April 200628/12/2007Namenda (Memantine) for Non-Motor Symptoms in Parkinson's DiseaseA 16 WEEK, INVESTIGATOR-INITIATED, SINGLE-CENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF NAMENDA® (MEMANTINE HCL) FOR NON-MOTOR SYMPTOMS IN PARKINSON'S DISEASEParkinson's DiseaseDrug: Memantine;Drug: placeboBaylor College of MedicineForest LaboratoriesCompleted18 Years80 YearsBoth40Phase 4United States
824EUCTR2005-004109-27-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
825EUCTR2005-001006-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
826EUCTR2005-003788-22-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
827EUCTR2005-004314-33-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
828EUCTR2005-004314-33-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
829NCT00307450
(ClinicalTrials.gov)
March 200627/3/2006Efficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's DiseaseEfficacy and Safety of Levetiracetam Versus Placebo on Levodopa-induced Dyskinesias in Advanced Parkinson's Disease (LeLeDys Study) - A Multicenter, Randomized, Stratified, Double-blinded, Placebo-controlled Phase IV StudyParkinson's DiseaseDrug: LevetiracetamTechnische Universität DresdenUCB GmbH, Huettenstrasse 205, 50170 Kerpen, GermanyCompleted30 Years80 YearsBoth34Phase 4Germany
830NCT00297778
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
831EUCTR2005-003788-22-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
832EUCTR2005-003788-22-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
833EUCTR2005-004314-33-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
834EUCTR2005-004290-19-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
835EUCTR2005-004314-33-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
836EUCTR2005-003788-22-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
837EUCTR2005-004314-33-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
838EUCTR2005-004314-33-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
839NCT00630500
(ClinicalTrials.gov)
February 200627/2/2008Efficacy and Safety of Memantine for Parkinson's Disease Dementia (PDD) and Dementia With Lewy Bodies (DLB)A Double-blind, Placebo-controlled Multicentre Trial of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy BodiesDementia Associated With Parkinson's Disease;Dementia With Lewy BodiesDrug: Memantine;Drug: PlaceboHelse Stavanger HFKing's College London;Lund UniversityCompletedN/AN/ABoth75Phase 2Norway;Sweden;United Kingdom
840NCT00286897
(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
841NCT00296192
(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
842EUCTR2005-004314-33-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
843EUCTR2005-004290-19-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
844EUCTR2005-003788-22-FI
(EUCTR)
17/01/200607/12/2005A 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: 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 Finland KyNot RecruitingFemale: yes
Male: yes
318Phase 1Finland;Germany;United Kingdom;Spain;Italy;Sweden
845EUCTR2005-004314-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
846EUCTR2005-003788-22-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
847NCT00279825
(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
848NCT00275275
(ClinicalTrials.gov)
January 20069/1/2006Pramipexole Conversion to Ropinirole Controlled Release (CR)An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.Parkinson DiseaseDrug: Requip PR;Drug: MirapexRajesh Pahwa, MDGlaxoSmithKlineCompleted18 YearsN/AAll61Phase 3United States
849NCT00292227
(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
850EUCTR2005-005120-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
851EUCTR2005-002432-10-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
852EUCTR2005-001416-42-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
853NCT00250393
(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
854NCT00256204
(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
855NCT00517842
(ClinicalTrials.gov)
October 200515/8/2007A Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's DiseaseA Triple-blinded, Randomised, Placebo-controlled Trial to Examine the Efficacy and Safety of ViNeuro in Patients With Parkinson's DiseaseParkinson DiseaseDrug: ViNeuroHospital Authority, Hong KongVigconic (International) Ltd.Completed30 YearsN/ABoth160N/AChina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
856NCT00134251
(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
857EUCTR2005-001416-42-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
858EUCTR2005-001416-42-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
859EUCTR2005-001416-42-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
860NCT00224263
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
861NCT02778594
(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
862NCT02774564
(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
863NCT00165789
(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
864EUCTR2005-001416-42-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
865EUCTR2005-001416-42-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
866EUCTR2004-000835-27-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
867EUCTR2005-004290-19-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
868EUCTR2005-001416-42-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
869EUCTR2005-004314-33-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
870NCT00642889
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
871EUCTR2004-002608-13-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
872NCT03093389
(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
873NCT00199433
(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
874NCT00163085
(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
875EUCTR2004-000817-20-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
876NCT00199355
(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
877EUCTR2004-001593-10-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
878NCT02834507
(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
879EUCTR2004-000817-20-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
880EUCTR2004-001594-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
881EUCTR2004-001594-25-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
882EUCTR2004-000817-20-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
883EUCTR2004-000835-27-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
884EUCTR2004-000833-12-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
885EUCTR2004-001593-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
886EUCTR2004-000833-12-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
887EUCTR2004-000185-12-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
888NCT00643045
(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
889EUCTR2004-000185-12-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
890EUCTR2004-001594-25-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
891EUCTR2004-000185-12-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
892EUCTR2004-000817-20-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
893NCT03091868
(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
894NCT00199394
(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
895EUCTR2004-000817-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
896EUCTR2004-000148-26-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
897EUCTR2004-000148-26-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
898NCT00105508
(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
899EUCTR2004-000148-26-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
900EUCTR2004-000185-12-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
901EUCTR2004-000817-20-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
902NCT00099268
(ClinicalTrials.gov)
September 200410/12/2004Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyA Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartis PharmaceuticalsOrion Corporation, Orion PharmaCompleted30 Years70 YearsAll747Phase 3United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
903NCT00296959
(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
904NCT00105521
(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
905NCT00501969
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
906EUCTR2004-000148-26-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
907NCT00199420
(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
908NCT00174239
(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
909EUCTR2004-000148-26-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
910NCT00199407
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
911NCT03091543
(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
912NCT01172379
(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
913NCT00244387
(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
914NCT00212693
(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
915NCT00220272
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
916NCT00363727
(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
917NCT00234676
(ClinicalTrials.gov)
October 20035/10/2005POETRY: Study of Estrogen Replacement Therapy in Postmenopausal Women With Parkinson's DiseaseA Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group Study for the Safety, Tolerability and Efficacy of Estrogen Replacement Therapy (Conjugated Equine Estrogens 0.625 mg Daily) in Post Menopausal Women With Parkinson's DiseaseParkinson's DiseaseDrug: Premarin ®The Parkinson Study GroupWyeth is now a wholly owned subsidiary of Pfizer;Joseph and Rosalyn Newman FoundationCompletedN/A75 YearsFemale23Phase 2United States
918NCT00180037
(ClinicalTrials.gov)
September 20039/9/2005Coenzyme Q10 as a Symptomatic Treatment in Parkinson's DiseaseMulticenter, Placebo Controlled, Randomized, Double-Blinded Study: Coenzyme Q10 Nanodispersion Versus Placebo as Symptomatic Treatment in Parkinson's DiseaseParkinson's DiseaseDrug: Coenzyme Q10 Nanodispersion (Nanoquinone);Drug: PlaceboTechnische Universität DresdenDeutsche Parkinson-Vereinigung e.V.;MSE Pharmazeutika GmbH, Bad HomburgCompleted40 Years75 YearsBoth132Phase 3Germany
919NCT00240409
(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
920NCT00228150
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
921NCT00666653
(ClinicalTrials.gov)
July 200323/4/2008Effects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's DiseaseEffects of a Dopamine Agonist on Pharmacodynamics of Levodopa in Parkinson's Disease: a Double-Blind Placebo Controlled Crossover StudyParkinson's DiseaseDrug: pramipexoleOregon Health and Science UniversityBoehringer IngelheimCompleted30 Years80 YearsBoth13Phase 1United States
922NCT00148486
(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
923NCT00381472
(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
924NCT00058838
(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
925NCT00148512
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
926NCT00115427
(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
927NCT00451815
(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
928NCT00209508
(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
929NCT00314288
(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
930NCT00456586
(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
931NCT00040404
(ClinicalTrials.gov)
March 200226/6/2002Safety and Efficacy Study of CEP-1347 in the Treatment of Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study to Assess the Efficacy and Safety of CEP-1347 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: CEP-1347 10mg;Drug: CEP1347 25mg;Drug: CEP-1347 50mg;Other: Placebo ComparatorCephalonH. Lundbeck A/S;The Parkinson Study GroupTerminated30 YearsN/ABoth806Phase 2;Phase 3United States;Canada;Puerto Rico
932NCT00456794
(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
933NCT02162979
(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
934NCT00030979
(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
935NCT00407212
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
936NCT00036218
(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
937NCT02772627
(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
938NCT00200525
(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
939NCT02763839
(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
940NCT02763852
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
941NCT00145171
(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
942NCT02763800
(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
943NCT00203034
(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
944NCT00200512
(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
945NCT02172573
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
946NCT00226460
(ClinicalTrials.gov)
August 199723/9/2005Phase 2, Double-blind, Randomized, Controlled Multi-center Clinical Trial of the Safety and Efficacy of Transplanted Fetal Porcine Cells in Patients With Parkinson's Disease.Parkinson's DiseaseDrug: Fetal porcine cells, Neurocell-PDGenzyme, a Sanofi CompanyDiacrin/Genzyme Corporation LLCCompleted40 Years70 YearsBothPhase 2United States
947NCT00203060
(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
948EUCTR2009-013552-72-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
949EUCTR2011-002073-30-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
950JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
951JPRN-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
952EUCTR2016-000657-12-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
953EUCTR2008-004447-11-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