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"
1070 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs041190126
01/02/202110/03/2020Study on efficacy and safety of zonisamide in at-risk subjects of Lewy body diseaseStudy on efficacy and safety of zonisamide in at-risk subjects of Lewy body disease - NaT-PROBEi Lewy body disease (Parkinson's disease and dementia with Lewy bodies)Arm zonisamide:
1.Two tablets of zonisamide 25mg after breakfast for 4 weeks
2.Four tablets of zonisamide 25mg after breakfast for 92 weeks
Arm placebo:
1.Two tablets of placebo after breakfast for 4 weeks
2.Four tablets of placebo after breakfast for 92 weeks
Katsuno MasahisaJapan Agency for Medical Research and DevelopmentPending>= 50age old< 80age oldBoth30Phase 2Japan
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
3NCT04373317
(ClinicalTrials.gov)
January 1, 202129/4/2020Pimavanserin vs. Quetiapine for the Treatment Parkinson's PsychosisCSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP)Parkinson's Disease PsychosisDrug: Pimavanserin;Drug: QuetiapineVA Office of Research and DevelopmentNULLNot yet recruiting40 YearsN/AAll358Phase 4United States
4NCT04377945
(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
5NCT04147949
(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
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
8EUCTR2019-003315-60-NL
(EUCTR)
10/11/202008/10/2020A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease - Buccal apomorphine (APORON) administration Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Apo-go
Product Name: APO-go®
INN or Proposed INN: Apomorphine
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Product Name: APORON
INN or Proposed INN: APORON
Other descriptive name: APOMORPHINE HYDROCHLORIDE HEMIHYDRATE
Criceto IKM B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
46Phase 1;Phase 2Netherlands
9EUCTR2019-004235-23-NL
(EUCTR)
09/11/202026/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;Italy;United Kingdom;Japan
10EUCTR2019-002952-17-CZ
(EUCTR)
04/11/202012/10/2020A clinical trial which runs in multiple countries and aims to evaluate the long-term safety and tolerability of the investigational product (TAVAPADON) for patients diagnosed with Parkinson's Disease58-Week Open-label Trial of Tavapadon in Parkinson’s Disease (TEMPO-4 Trial) - TEMPO-4 Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
854Phase 3United States;Serbia;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04542499
(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
12JPRN-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
13NCT03947216
(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
14NCT04334317
(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
15NCT04380142
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR2000037239
2020-10-012020-08-27Construction and application of a diagnostic marker for Parkinson's disease based on gut microbiomicsConstruction and application of a diagnostic marker for Parkinson's disease based on gut microbiomics Parkinson's diseaseGold Standard:All patients satisfied the United Kingdom Parkinson's Disease Society Brain Bank criteria;Index test:Microbial gene detection chip;Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineNULLRecruiting5580BothTarget condition:500;Difficult condition:600China
17NCT04593511
(ClinicalTrials.gov)
October 202021/9/2020to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 in Healthy VolunteersAn Open-Label Study in Healthy Volunteers to Evaluate the Safety, Tolerability and Pharmacokinetics of Four Formulations of LY03009 After a Single Intramuscular InjectionParkinson's DiseaseDrug: LY03009 F1;Drug: LY03009 F2;Drug: LY03009 F3;Drug: LY03009 F4Luye Pharma Group Ltd.NULLNot yet recruiting18 Years65 YearsAll40Phase 1NULL
18NCT04338997
(ClinicalTrials.gov)
October 20203/4/2020PK Study in Patients With Parkinson's Disease With IZD174An Open-label Phase 1b Study to Evaluate the Pharmacokinetics and Pharmacodynamics in Plasma and Cerebrospinal Fluid (CSF), Safety and Tolerability of Oral IZD174 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: IZD174Inflazome UK LtdNULLWithdrawn45 Years75 YearsAll0Phase 1NULL
19EUCTR2019-004235-23-GB
(EUCTR)
15/09/202028/05/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
Abbvie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Japan;United Kingdom
20NCT04476017
(ClinicalTrials.gov)
September 11, 202015/7/2020A Study to Evaluate the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive Impairment (PD-MCI)An Open-Label Evaluation of the Safety and Tolerability of SAGE-718 in Participants With Parkinson's Disease Mild Cognitive ImpairmentParkinson Disease;Cognitive DysfunctionDrug: SAGE-718Sage TherapeuticsNULLRecruiting50 Years75 YearsAll22Phase 2United States
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
22EUCTR2019-004235-23-IT
(EUCTR)
26/08/202022/10/2020Parkinson's Disease: An extension of Study M15-741 evaluating the safety and tolerability of ABBV-951 in subjects with Parkinson's disease.An open-label extension of Study M15-741 to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease. - na Parkinson's Disease
MedDRA version: 21.1;Level: PT;Classification code 10068100;Term: Vascular parkinsonism;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Foscarbidopa and Foslevodopa
Product Code: [ABBV-951]
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
ABBVIE DEUTSCHLAND GMBH & CO. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Australia;Russian Federation;Netherlands;United Kingdom;Japan;Italy
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
25NCT04483479
(ClinicalTrials.gov)
July 30, 202020/7/2020Orally Administered ENT-01 for Parkinson's Disease-Related Constipation Follow-on Safety Roll-over Study (Rollover)A Multicenter, Non-Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Orally Administered ENT-01 in Improving Constipation and Neurologic Symptoms in Patients With Parkinson's Disease and Constipation Over a 14-week PeriodParkinson Disease;ConstipationDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLRecruiting30 Years90 YearsAll50Phase 2United States
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-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
27NCT04630860
(ClinicalTrials.gov)
July 7, 20205/11/2020A Study to Evaluate the Pharmacokinetics and Safety of LY03003 in Patients With Advanced-stage PDA Randomized, Open-label, Multiple Ascending Dose Study in Patients With Advanced-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLRecruiting18 Years80 YearsAll30Phase 1China
28EUCTR2019-002951-40-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
29EUCTR2018-004156-37-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
30EUCTR2018-004156-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04428112
(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
32EUCTR2019-002951-40-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
33NCT04379050
(ClinicalTrials.gov)
May 19, 20201/5/2020Extension Study To Evaluate Safety And Tolerability Of 24-Hour Daily Exposure Of Continuous Subcutaneous Infusion of ABBV-951 In Adult Participants With Parkinson's DiseaseAn Open-label Extension of Study M15-741 to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLEnrolling by invitation30 YearsN/AAll121Phase 3United States;Australia;Belgium;Canada;Denmark;Italy;Japan;Netherlands;Spain;United Kingdom
34EUCTR2018-004156-37-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
35EUCTR2019-002949-38-PL
(EUCTR)
13/05/202020/02/2020A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL)A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, 27 WEEK TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TWO FIXED DOSES OF TAVAPADON IN EARLY PARKINSON’S DISEASE (TEMPO-1 TRIAL) Patients (40 to 80 years age) who have diagnosis of Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tavapadon 0.25mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 1mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Product Name: Tavapadon 5mg
Product Code: CVL-751
INN or Proposed INN: TAVAPADON
Other descriptive name: PF-06649751
Cerevel Therapeutics, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
522Phase 3Serbia;United States;Spain;Ukraine;Israel;Italy;France;Czech Republic;Hungary;Canada;Poland;Australia;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04571164
(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
37EUCTR2018-002144-85-DE
(EUCTR)
07/05/202006/06/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;Germany;United Kingdom;Japan
38EUCTR2019-002950-22-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
39EUCTR2018-004156-37-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
40EUCTR2018-004156-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-002233-37-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
42EUCTR2019-002951-40-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
43EUCTR2019-002949-38-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
44NCT04167540
(ClinicalTrials.gov)
April 1, 20207/11/2019GDNF Gene Therapy for Parkinson's DiseaseOpen-Label Safety Study of Glial Cell Line-Derived Neurotrophic Factor Gene Transfer (AAV2- GDNF) in Parkinson's DiseaseParkinson's DiseaseBiological: AAV2-GDNFBrain Neurotherapy Bio, Inc.NULLRecruiting35 Years75 YearsAll12Phase 1United States
45NCT04269642
(ClinicalTrials.gov)
March 19, 202013/1/2020SR-Exenatide (PT320) to Eveluate Efficacy and Safety in Patients With Early Parkinson's DiseasePhase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's DiseaseEarly Parkinson's DiseaseDrug: PT320 2.0mg Placebo;Drug: PT320 2.0 mg;Drug: PT320 2.5 mgPeptron, Inc.NULLRecruiting40 Years75 YearsAll99Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2018-003941-41-AT
(EUCTR)
05/03/202019/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
47EUCTR2019-002949-38-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
48NCT04127695
(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
49EUCTR2018-004156-37-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
50NCT04353947
(ClinicalTrials.gov)
March 2, 202016/4/2020Induction and Recognition of EmotionsInduction and Recognition of Emotions in Healthy Older Adults, Alzheimer's Disease and Parkinson's DiseaseHealthy Older Adults;Alzheimer's Disease;Parkinson's DiseaseDiagnostic Test: Mini Cognitive Examination (MCE);Diagnostic Test: Beck Depression Inventory-II (BDI-II);Diagnostic Test: Global Deterioration Scale (GDS);Diagnostic Test: Memory alteration test (M@T);Diagnostic Test: Spanish-Complutense Verbal Learning Test (TAVEC);Diagnostic Test: Barcelona test (BT);Diagnostic Test: Rey-Osterrieth Complex Figure Test (ROCFT);Diagnostic Test: Frontal assessment battery (FAB);Diagnostic Test: Positive and Negative Affect Scale (PANAS);Diagnostic Test: Auto-Assessment Manikins (SAM)University of ValenciaAsociación Parkinson ValenciaRecruiting65 Years99 YearsAll60Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04154072
(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
52NCT04291859
(ClinicalTrials.gov)
February 26, 202028/2/2020Lu AF28996 in Patients With Parkinson's Disease (PD)Interventional, Open-label, Exploratory Study, Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AF28996 in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Lu AF28996H. Lundbeck A/SNULLRecruiting45 Years75 YearsAll10Phase 1Netherlands
53EUCTR2018-004156-37-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
54EUCTR2019-002949-38-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
55EUCTR2018-002234-21-GB
(EUCTR)
05/02/202004/07/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04251585
(ClinicalTrials.gov)
February 4, 202028/1/2020Intranasal Insulin in Parkinson's DiseaseSingle Center Safety and Tolerability Trial of Intranasal Insulin in Parkinson's DiseaseParkinson DiseaseDrug: Regular Novolin R;Drug: PlaceboHealthPartners InstituteNULLRecruiting41 Years89 YearsAll30Phase 2United States
57EUCTR2018-003941-41-PT
(EUCTR)
03/02/202021/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure
MedDRA version: 20.0;Level: LLT;Classification code 10021102;Term: Hypotension orthostatic symptomatic;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
58EUCTR2018-003289-15-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
59NCT04220762
(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
60NCT04369430
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2018-004156-37-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
62EUCTR2019-001657-42-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
63EUCTR2018-003289-15-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
64NCT04295642
(ClinicalTrials.gov)
January 8, 202024/1/2020A 2-Part Trial of CVL-751 in Subjects With Parkinson's DiseaseA 2-Part, Open Label, Adaptive, Single and/or Multiple Oral Dose, Safety, Tolerability, and Food Effect Trial of CVL-751 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: CVL-751Cerevel Therapeutics, LLCNULLRecruiting45 Years75 YearsAll33Phase 1United States
65NCT04223193
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT04127578
(ClinicalTrials.gov)
January 3, 202014/10/2019Phase 1/2a Clinical Trial of PR001A in Patients With Parkinson's Disease With at Least One GBA1 Mutation (PROPEL)A Phase 1/2a Open-Label Ascending Dose Study to Evaluate the Safety and Effects of PR001A in Patients With Parkinson's Disease With at Least One GBA1 MutationParkinson DiseaseBiological: PR001A;Drug: Methylprednisolone;Drug: Sirolimus;Drug: PrednisonePrevail TherapeuticsNULLRecruiting35 Years80 YearsAll12Phase 1;Phase 2United States
67NCT04152655
(ClinicalTrials.gov)
January 1, 20207/10/2019A Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson DiseaseA Study of Efficacy and Safety of Idebenone vs. Placebo in Prodromal Parkinson Disease (SEASEiPPD)REM Sleep Behavior Disorder;Parkinson DiseaseDrug: Idebenone;Drug: Placebo oral tabletSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLRecruiting18 YearsN/AAll180Phase 2;Phase 3China
68NCT04301492
(ClinicalTrials.gov)
January 1, 202017/2/2020Tolerability, Safety and Efficacy of VortioxetineTolerability, Safety and Efficacy of Vortioxetine for Treatment od Depression in Parkinson's Disease: a 16 Week Open Label StudyDepressionDrug: VortioxetineIRCCS San RaffaeleNULLRecruiting30 Years80 YearsAll20Phase 4Italy
69NCT03446807
(ClinicalTrials.gov)
January 202020/2/2018Safety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismSafety and Efficacy of Droxidopa for Fatigue in Patients With ParkinsonismParkinson Disease;Multiple System Atrophy;Progressive Supranuclear PalsyDrug: Droxidopa;Drug: Placebo Oral TabletLoma Linda UniversityH. Lundbeck A/SNot yet recruiting50 YearsN/AAll32Phase 2United States
70EUCTR2018-004156-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT04201093
(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
72NCT04183634
(ClinicalTrials.gov)
December 3, 201928/11/2019An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.An Open, Randomised, Single Dose, 2-period, 2-sequence Crossover Adhesion Study of Two Different Transdermal Patches Containing Rotigotine.Parkinson DiseaseDrug: Rotigotine TTS (Test);Drug: Neupro (Reference)SandozNULLTerminated18 Years80 YearsAll31Phase 1Germany
73NCT04044131
(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
74EUCTR2018-004156-37-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
75NCT03924414
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT04175132
(ClinicalTrials.gov)
November 12, 201912/11/2019Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)Interventional, Open-label, Positron Emission Tomography (PET) Study With [11C]-PXT012253 Investigating the Brain mGlu4 Receptor Occupancy, Safety, Tolerability and Pharmacokinetics of Foliglurax in Healthy Subjects and Patients With Parkinson's DiseaseHealthy;Parkinson DiseaseDrug: foligluraxH. Lundbeck A/SNULLTerminated50 Years70 YearsAll6Phase 1Sweden
77EUCTR2018-003941-41-DK
(EUCTR)
29/10/201924/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Denmark;Australia;Bulgaria;Germany;New Zealand
78NCT04164758
(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
79EUCTR2019-001657-42-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
80EUCTR2018-003337-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT04157933
(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
82NCT04165837
(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
83EUCTR2018-002233-37-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
84EUCTR2018-003289-15-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
85EUCTR2018-003941-41-BG
(EUCTR)
10/10/201926/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03987750
(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
87EUCTR2018-002234-21-DE
(EUCTR)
23/09/201916/05/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: ANHYDROUS CARBIDOPA
Product Name: IPX203
Product Code: IPX203
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
88EUCTR2018-002144-85-NL
(EUCTR)
11/09/201927/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
89NCT04477161
(ClinicalTrials.gov)
September 5, 201922/6/2020Effect of Ketone Esters in Parkinson's DiseaseEffect of Ketone Esters on Parkinson Disease: A Pilot, Prospective Trial.Parkinson Disease;KetosisDietary Supplement: Ketone Ester Elite endurance Nutrition Drink;Other: Stool SampleUniversity of FloridaNULLRecruiting40 Years75 YearsAll15N/AUnited States
90NCT03959540
(ClinicalTrials.gov)
September 201923/4/2019Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseA Multinational, Multicentre, Prospective Non-interventional Study to Assess Safety and Effectiveness of Opicapone Plus Standard of Care in Elderly Patients With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Levodopa (L-DOPA) + Standard careBial - Portela C S.A.NULLNot yet recruiting75 YearsN/AAll100NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT04075318
(ClinicalTrials.gov)
August 29, 20195/8/2019Study of UB-312 in Healthy Participants and Parkinson's Disease PatientsA Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's DiseaseParkinson Disease;ParkinsonismBiological: UB-312;Biological: PlaceboUnited Neuroscience Ltd.Centre for Human Drug Research, Netherlands;Worldwide Clinical TrialsActive, not recruiting40 Years85 YearsAll62Phase 1Netherlands
92NCT04006210
(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
93EUCTR2018-003941-41-PL
(EUCTR)
23/08/201903/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3Portugal;United States;Estonia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
94EUCTR2018-002234-21-ES
(EUCTR)
21/08/201911/06/2019An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
95EUCTR2018-002144-85-BE
(EUCTR)
20/08/201924/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Belgium;Denmark;Australia;Germany;Netherlands;United Kingdom;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2018-003941-41-ES
(EUCTR)
13/08/201911/06/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic NeurogenicOrthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
97NCT03976349
(ClinicalTrials.gov)
August 12, 20194/6/2019A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BIIB094 in Adults With Parkinson's DiseaseA Phase 1 Single- and Multiple-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB094 Administered Intrathecally to Adults With Parkinson's DiseaseParkinson's DiseaseDrug: BIIB094;Drug: PlaceboBiogenIonis Pharmaceuticals, Inc.Recruiting35 Years80 YearsAll82Phase 1United States;Canada;Israel;Norway;Spain;United Kingdom
98NCT04043338
(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
99EUCTR2018-003941-41-GB
(EUCTR)
09/08/201916/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH)A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TD-9855
INN or Proposed INN: ampreloxetine hydrochloride
Other descriptive name: TD-9855
Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
258Phase 3United States;Portugal;Estonia;Spain;Ukraine;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Mexico;Canada;Argentina;Poland;Peru;Australia;Denmark;Bulgaria;Germany;New Zealand
100NCT03881371
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2018-003941-41-HU
(EUCTR)
30/07/201901/08/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
102EUCTR2018-002144-85-GB
(EUCTR)
29/07/201913/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Belgium;Spain;Denmark;Australia;Germany;Netherlands;Japan;United Kingdom
103NCT04056689
(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
104NCT03956979
(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
105EUCTR2018-003289-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106NCT03575195
(ClinicalTrials.gov)
July 15, 201921/6/2018Microbiota Intervention to Change the Response of Parkinson's DiseaseMicrobiota Intervention to Change the Response of Parkinson's DiseaseParkinson DiseaseDrug: Rifaximin;Other: PlaceboUniversity of California, San FranciscoNova Southeastern University;Gateway Institute for Brain ResearchRecruiting30 YearsN/AAll86Phase 1;Phase 2United States
107EUCTR2018-002144-85-ES
(EUCTR)
11/07/201912/04/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
108EUCTR2018-002144-85-DK
(EUCTR)
08/07/201914/03/2019Parkinson's Disease: Safety and Tolerability of 24-Hour Daily Exposure to ABBV-951 by Continuous Subcutaneous Infusion studyA 52-Week, open-label, single-arm study to evaluate the safety and tolerability of 24-hour daily exposure of continuous subcutaneous infusion of ABBV-951 in subjects with Parkinson's disease - Galliarde Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: ABBV-951
INN or Proposed INN: Foslevodopa
Other descriptive name: Levodopa-4'-Monophosphate
INN or Proposed INN: Foscarbidopa
Other descriptive name: Carbidopa-4'-Monophosphate
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United States;Canada;Spain;Australia;Denmark;Netherlands;United Kingdom;Japan
109EUCTR2018-003941-41-EE
(EUCTR)
04/07/201929/05/2019This study will look at whether an investigational drug, called TD-9855, works and how safe it is when taken over a longer period of time to treat symptomatic neurogenic orthostatic hypotension (snOH) in people with Parkinson’s disease (PD), multiple system atrophy (MSA), or pure autonomic failure (PAF). It will also look at the effects of TD-9855 on general well-being and whether it can improve symptoms of neurogenic OH (nOH) A Phase 3, 22-week, Multi-center, Randomized Withdrawal Study of TD-9855 in Treating Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure - Redwood Symptomatic Neurogenic Orthostatic Hypotension in Subjects with Primary Autonomic Failure;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Theravance Biopharma Ireland LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
258Phase 3United States;Estonia;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Australia;Denmark;Bulgaria;Germany;New Zealand
110EUCTR2018-003289-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03977441
(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
112EUCTR2018-003289-15-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
113EUCTR2018-003337-15-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
114EUCTR2018-002234-21-CZ
(EUCTR)
14/06/201930/05/2019 An open-label extension study of the safety and clinical utility of IPX203 in Parkinson’s Disease patients with motor fluctuationsAN OPEN-LABEL EXTENSION STUDY OF THE SAFETY AND CLINICAL UTILITY OF IPX203 IN PARKINSON’S DISEASE PATIENTS WITH MOTOR FLUCTUATIONS Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;Classification code 10028035;Term: Movement disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Impax Laboratories, LLCNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 3United States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
115EUCTR2018-003337-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2018-003289-15-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
117NCT03971617
(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
118EUCTR2018-003289-15-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
119NCT03671785
(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
120NCT04293159
(ClinicalTrials.gov)
May 14, 201919/2/2020Effect of Probiotic on Constipation in Patients With Parkinson's DiseaseEffect of Probiotic on Constipation and on Neuropsychological Performance in Patients With Parkinson's DiseaseParkinson Disease;ConstipationDietary Supplement: Lactobacillus casei DG (Enterolactis duo®)University of SalernoRoberto Erro;Maria Teresa Pellecchia;Antonella Santonicola;Carolina CiacciRecruiting18 Years75 YearsAll30N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2018-003289-15-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
122NCT03781167
(ClinicalTrials.gov)
April 29, 201918/12/2018A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLRecruiting30 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;Germany;Italy;Japan;Netherlands;Russian Federation;Spain;Sweden;United Kingdom;France
123NCT03899324
(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
124JPRN-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
125EUCTR2018-002233-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126EUCTR2018-003289-15-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
127NCT03661125
(ClinicalTrials.gov)
April 11, 20194/9/2018SRC Inhibition as a Potential Target for Parkinson's Disease PsychosisA Randomised, Balanced, Double-blind Two-way Crossover Design Study to Evaluate the Effects of SRC Kinase Inhibitor, Saracatinib, on Brain Activity Associated With Visual Processing in Patients With Parkinson's Disease Psychosis.Parkinson Disease PsychosisDrug: Saracatinib;Drug: Placebo Oral TabletKing's College LondonAstraZeneca;King's College Hospital NHS TrustRecruiting40 YearsN/AAll30Early Phase 1United Kingdom
128NCT03841604
(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
129EUCTR2016-000657-12-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
130NCT03877510
(ClinicalTrials.gov)
April 3, 201912/3/2019Open Label Extension (OLE) Study of the Safety and Clinical Utility of IPX203 in PD Patients With Motor FluctuationsAn Open-label Extension Study of the Safety and Clinical Utility of IPX203 in Parkinson's Disease Patients With Motor FluctuationsParkinson DiseaseDrug: IPX203 140 mg;Drug: IPX203 210 mg;Drug: IPX203 280 mg;Drug: IPX203 350 mgImpax Laboratories, LLCNULLEnrolling by invitation40 YearsN/AAll300Phase 3United States;Czechia;France;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131ChiCTR1800015757
2019-04-012018-04-18Value of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's diseaseValue of 131I-MIBG salivary gland imaging in the early diagnosis of Parkinson's disease Parkinson's DiseaseGold Standard:PD diagnostic criteria made by MDS in 2016;Index test:reduced uptake in salivery gland and myocardium in I-131-MIBG scintigraphic imaging;Tongji hospital, Tongji UniversityNULLPendingBothTarget condition:30;Difficult condition:30China
132NCT03922711
(ClinicalTrials.gov)
March 26, 201917/4/2019A Study to Assess the Safety and Effectiveness of Pridopidine Compared to Placebo in the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's DiseaseA Double-Blind, Randomized, Three-Arm, Parallel-Group Study to Assess the Efficacy and Safety of Two Doses of Pridopidine Versus Placebo for the Treatment of Levodopa-Induced Dyskinesia in Patients With Parkinson's Disease (gLIDe)Parkinson DiseaseDrug: Pridopidine;Drug: PlaceboPrileniaNULLTerminated30 Years85 YearsAll23Phase 2United States
133NCT03716570
(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
134EUCTR2017-005170-19-FI
(EUCTR)
06/03/201907/12/2018A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension StudyA Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Renishaw Neuro Solutions Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
135NCT03655236
(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
136NCT03968744
(ClinicalTrials.gov)
February 18, 201919/4/2019Effect of Safinamide on Sleep Quality in Patients With Parkinson's DiseaseA Prospective, Open Label, Single Arm, Clinical Study to Evaluate the Effect of Safinamide on Sleep Quality and Polysomnographic Parameters in Patients With Parkinson's Disease: the Safe Sleep StudyIdiopathic Parkinson's Disease (at Later Stage)Drug: SafinamideAlain KaelinClinical Trial Unit Ente Ospedaliero CantonaleRecruiting18 YearsN/AAll23Phase 4Switzerland
137NCT03413384
(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
138NCT03815071
(ClinicalTrials.gov)
February 1, 201921/1/2019A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem CellsClinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's DiseaseParkinson DiseaseDrug: Ips-nsc cellsAllife Medical Science and Technology Co., Ltd.The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital;Henan Provincial People's Hospital;Beijing HospitalNot yet recruiting18 Years60 YearsAll10Early Phase 1NULL
139NCT03790670
(ClinicalTrials.gov)
January 30, 201918/12/2018Biomarker Assessments of Leukine During Treatment of Parkinson's DiseaseSafety, Tolerability and Biomarker Assessments of Leukine (Sargramostim) During Extended Timed Treatment for Parkinson's Disease: A Phase I Pilot StudyParkinson DiseaseDrug: sargramostimUniversity of NebraskaNULLRecruiting35 Years85 YearsAll10Phase 1United States
140EUCTR2017-002426-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03840005
(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
142NCT03781791
(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
143NCT03710707
(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
144NCT03639064
(ClinicalTrials.gov)
December 20184/7/2018Cannabis Oil for Pain in Parkinson's DiseaseA Phase II, Randomized, Open-label, Double-blind, Two-center Study to Evaluate the Tolerability, Safety and Dose-finding of Oil Cannabis Preparation for Pain in Parkinson's DiseaseParkinson DiseaseDrug: Cannabis OilUniversity Health Network, TorontoParkinson Society CanadaUnknown status18 YearsN/AAll15Phase 2NULL
145NCT03822364
(ClinicalTrials.gov)
November 26, 201818/12/2018Staccato Apomorphine Single and Multi Dose PKA Randomized Study of the Safety, Tolerability, and Pharmacokinetics of AZ-009 (Staccato Apomorphine) in Healthy Volunteers and the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZ-009 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: 009-1;Drug: active comparator;Drug: 009-0;Drug: 009-2;Drug: 009-3;Drug: 009-4;Drug: 009-5Alexza Pharmaceuticals, Inc.NULLCompleted18 Years60 YearsAll56Phase 1Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT03823638
(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
147NCT03713957
(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
148EUCTR2018-001887-46-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
149NCT03670953
(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
150NCT03667404
(ClinicalTrials.gov)
November 6, 201810/9/2018Resistant Maltodextrin for Gut Microbiome in Parkinson's Disease: Safety and Tolerability StudyGut Microbial Remodeling With Resistant Maltodextrin for Motor and Non-motor Symptoms in Parkinson's Disease: Safety and Tolerability StudyParkinson Disease;Intestinal Bacteria Flora Disturbance;Dietary ModificationDietary Supplement: Resistant maltodextrin;Dietary Supplement: maltodextrinNorthwestern UniversityUniversity of Illinois at ChicagoRecruiting60 YearsN/AAll30Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT04629404
(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
152JPRN-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
153NCT03727139
(ClinicalTrials.gov)
November 1, 201830/10/2018Rasagiline Tablets Special Drug Use-Results Survey Survey on Long-term SafetyAZILECT Tablets Special Drug Use-Results Survey Survey on Long-term SafetyParkinson's DiseaseDrug: RasagilineTakedaNULLActive, not recruitingN/AN/AAll1021Japan
154EUCTR2017-003415-19-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
155EUCTR2016-002033-30-NL
(EUCTR)
31/10/201815/11/2017A clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion given as adjunct treatment to oral levodopa in patients with Parkinson’s disease with motor fluctuationsA multicenter, randomized, double-blind, placebo controlled, parallel group clinical study investigating the efficacy, tolerability, and safety of two dosing regimens of continuous subcutaneous ND0612 infusion Given as adjunct treatment to oral levOdopa in patients with Parkinson’s Disease with motor fluctuations (iNDiGO) - iNDiGO Subjects with Parkinson’s Disease with motor fluctuations
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240Phase 3Serbia;Portugal;United States;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2017-002426-20-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
157NCT03720418
(ClinicalTrials.gov)
October 17, 201816/10/2018Study of OXB-102 (AXO-Lenti-PD) in Patients With Bilateral, Idiopathic Parkinson's DiseaseA Phase I/II Safety and Dose Evaluation Study of OXB-102 in Patients With Bilateral Idiopathic Parkinson's DiseaseParkinson DiseaseDrug: OXB-102;Other: Imitation Surgical Procedure (ISP)Axovant Sciences Ltd.Oxford BioMedicaRecruiting30 Years70 YearsAll30Phase 1;Phase 2France;United Kingdom
158EUCTR2018-000346-19-FI
(EUCTR)
03/10/201809/07/2018An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
159EUCTR2016-004610-95-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
160NCT03665454
(ClinicalTrials.gov)
September 24, 20181/8/2018PF 06412562 in Subjects With Advanced Stage Parkinson's DiseaseA Phase Ib Safety, Tolerability, and Efficacy Study of Two Days of Oral Split Dose (25/20 mg) Administration of PF 06412562 in Subjects With Advanced Stage Parkinson's DiseaseParkinson DiseaseDrug: PF-06412562;Drug: Standard of Care PlaceboMilton S. Hershey Medical CenterPfizerCompletedN/AN/AAll8Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT04202757
(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
162NCT03608371
(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
163EUCTR2016-004610-95-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
164NCT03773796
(ClinicalTrials.gov)
August 6, 201819/7/2018Nabilone for Non-motor Symptoms in Parkinson's DiseaseNabilone for Non-motor Symptoms in Parkinson's Disease: An Open-label Study to Evaluate Long-term Safety and EfficacyParkinson DiseaseDrug: Nabilone 0.25 mgMedical University InnsbruckNULLRecruiting30 Years100 YearsAll48Phase 3Austria
165JPRN-JMA-IIA00385
01/08/201812/09/2018Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's DiseaseKyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease Parkinson's diseaseIntervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value..Kyoto University HospitalNULLTemporarily Closed>=50 YEARS<70 YEARSBOTH7Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166NCT04455555
(ClinicalTrials.gov)
August 1, 201828/6/2020Efficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseEfficacy and Safety of Rotigotine in the Treatment of Patients With Early Stage of Primary Parkinson's DiseaseParkinson's DiseaseDrug: LY03003( the name of rotigotine);Other: PlaceboPeking University Third HospitalNULLCompleted18 YearsN/AAll294Phase 3China
167EUCTR2017-005170-19-SE
(EUCTR)
30/07/201810/04/2018A Long-Term Follow-up Safety Study for Patients with Parkinson’s Disease (PD) Implanted with the Drug Delivery System (DDS) and/or Who Received Treatment in the Main Study and/or Extension StudyA Long-Term Follow-up Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Implanted with the DDS and/or Who Received Treatment in the Main Study and/or Extension Study - Long-Term Follow-up Safety After DDS Implantation with/without CDNF Infusions Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Renishaw Neuro Solutions Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Finland;Sweden
168NCT03611569
(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
169NCT03624920
(ClinicalTrials.gov)
July 12, 201810/7/2018Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessSafety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime SleepinessParkinson DiseaseDrug: THN102 Dosage A;Drug: THN102 Dosage B;Drug: THN102 Dosage CTheranexusNULLCompleted18 Years80 YearsAll77Phase 2United States;Czechia;France;Germany;Hungary
170NCT03774459
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT03775538
(ClinicalTrials.gov)
July 5, 201811/10/2018Safety of CDNF by Brain Infusion in Patients With Parkinson's Disease. Extension to HP-CD-CL-2002 Clinical StudyA Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients With Idiopathic Parkinson's Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002Parkinson Disease;Movement Disorders;Neuro-Degenerative Disease;Nervous System Diseases;Brain DiseasesDrug: Cerebral Dopamine Neurotrophic Factor;Device: Renishaw Drug Delivery SystemHerantis Pharma Plc.Renishaw plc.Completed35 Years75 YearsAll15Phase 1;Phase 2Finland;Sweden
172EUCTR2017-004335-36-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
173NCT03521635
(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
174NCT03562494
(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
175EUCTR2017-001420-21-DE
(EUCTR)
18/06/201816/02/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2017-001420-21-ES
(EUCTR)
13/06/201815/03/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
177EUCTR2018-000346-19-SE
(EUCTR)
04/06/201809/04/2018An extended clinical study to test the safety of Cerebral Dopamine Neurotrophic Factor (CDNF) by brain infusion via Drug Delivery System (DDS) in patients with Parkinson's disease.A Randomised, Double-Blind, Multi-centre, Active Treatment, Extension and Safety Study for Patients with Idiopathic Parkinson’s Disease (PD) Who Previously Completed the CDNF/DDS Main Study HP-CD-CL-2002. - Extension Study Idiopathic Parkinson's Disease
MedDRA version: 21.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cerebral Dopamine Neurotrophic Factor
Product Code: CDNF
INN or Proposed INN: Not Applicable
Other descriptive name: recombinant human Cerebral Dopamine Neurotrophic Factor
Herantis Pharma PlcNULLNot RecruitingFemale: yes
Male: yes
18Phase 1;Phase 2Finland;Sweden
178NCT03532984
(ClinicalTrials.gov)
June 1, 201827/4/2018Beam Walking Across the Lifespan for Falls PredictionBeam Walking to Assess Dynamic Balance in Health and Disease: A Protocol for the 'BEAM' Multi-center Observational StudyAging;Parkinson Disease;Stroke;Dementia;Diagnoses Disease;Cognitive Impairment;Postural; DefectDiagnostic Test: Beam test to predict fallsUniversity Medical Center GroningenDokkyo Medical University;University of Potsdam;Somogy Megyei Kaposi Mór Teaching Hospital;University of Sao PauloUnknown status20 Years80 YearsAll432Brazil;Germany;Hungary;Japan;Netherlands
179NCT03684122
(ClinicalTrials.gov)
June 1, 201823/9/2018Use of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) in People With Parkinson's (PD).A Safety and Efficacy Study of the Effects of Mesenchymal Stem Cells (MSCs) Differentiated Into Neural Stem Cells (NSCs) on the Motor and Non-motor Symptoms in People With Parkinson's Disease (PD).Parkinson DiseaseBiological: Injection of Umbilical cord derived MSCsUniversity of JordanNULLRecruiting20 Years75 YearsAll10Phase 1;Phase 2Jordan
180NCT03891069
(ClinicalTrials.gov)
June 1, 201818/3/2019Feasibility of the AHA Exergame System in Parkinson's Disease PatientsFeasibility and Safety of the AHA Exergame System in Parkinson's Disease Patients: a Mixed Methods StudyParkinson DiseaseDevice: AHA Exergame SystemCampus Neurológico SéniorUniversity of LisbonCompleted40 Years80 YearsAll10N/APortugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2016-004610-95-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
182EUCTR2017-004475-31-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
183NCT03541356
(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
184EUCTR2016-004610-95-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
185NCT03843944
(ClinicalTrials.gov)
May 1, 201812/2/2019Overnight Switch From Rasagiline To SafinamideOvernight Switch From Rasagiline To Safinamide In Fluctuating Patients With Parkinson's Disease: A Tolerability And Safety StudyParkinson DiseaseDrug: SafinamideIRCCS San RaffaeleNULLCompleted30 Years80 YearsAll20Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT03374917
(ClinicalTrials.gov)
April 18, 20188/12/2017A Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 in an Outpatient EnvironmentAn Open-Label Study in Subjects With Parkinson's Disease to Evaluate the Safety and Tolerability of Titration and Continuous Subcutaneous Infusion of ABBV-951 for up to 4 Weeks in an Outpatient EnvironmentParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted30 Years85 YearsAll20Phase 1United States
187EUCTR2017-004475-31-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
188EUCTR2017-004253-16-AT
(EUCTR)
13/04/201827/02/2018Investigation of the effect of Nabilon in patients suffering from Parkinson´s Disease with non-Motor symptoms (e.g.sleeping dirsorders, cognitive dysfunction, hallucinations, autonomic dysfunction,...)Nabilone for non-motor symptoms in Parkinson’s disease: An open-label study to evaluate long-term safety and efficacy Subject with non-Motor symptoms of Parkinson´s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Medizinische Universität Innsbruck, Universitätsklinik für NeurologieNULLNot Recruiting Female: yes
Male: yes
48Phase 3Austria
189EUCTR2017-002707-10-DK
(EUCTR)
10/04/201803/11/2017Measurements of drug concentration in the blood for anti-dementia drugs, in order to improve efficacy and reduce side-effectsSerum-monitoring of anti-dementia drugs, and the relevance to side-effects, clinical efficacy and compliance Dementia in Alzheimers Disease, Parkinsons Disease and Dementia with Lewy Bodies
MedDRA version: 20.0;Level: PT;Classification code 10012271;Term: Dementia Alzheimer's type;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10012284;Term: Dementia due to Parkinson's disease;Classification code 10067889;Term: Dementia with Lewy bodies;Classification code 10075174;Term: Mixed dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Memantin Orion
INN or Proposed INN: MEMANTINE
Product Name: Donepezil Sandoz
Product Code: 25330
INN or Proposed INN: DONEPEZIL
Regional Dementia Research Centre, Dept of NeurologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
110Phase 4Denmark
190NCT03648671
(ClinicalTrials.gov)
March 28, 201826/6/2018Pain in Parkinson's Disease With Motor Fluctuations.Spontaneous and Evoked Pain in Parkinson's Disease With Motor Fluctuations: an Observational, Prospective, Clinical and Neurophysiological Study in Patients Under L-dopa Add on Therapies.Parkinson DiseaseDrug: safinamide metansolfonato (12 weeks);Drug: rasagilina mesilato (12 weeks)Universita di VeronaAzienda Ospedaliera Universitaria Integrata VeronaUnknown status18 Years80 YearsAll48Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2016-004610-95-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
192NCT03482882
(ClinicalTrials.gov)
March 9, 201823/3/2018Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and DepressionAn Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and DepressionTreatment of Depression in Adults With Parkinson's Disease (PD)Drug: PimavanserinACADIA Pharmaceuticals Inc.NULLCompleted50 YearsN/AAll47Phase 2United States
193NCT03496870
(ClinicalTrials.gov)
February 8, 20181/3/2018A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Opicapone in Subjects With Parkinson's Disease Taking Levodopa.A Phase 1, Open-Label Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Repeated Doses of Opicapone, and Effect on Levodopa Pharmacokinetics in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: Opicapone;Drug: Carbidopa LevodopaNeurocrine BiosciencesNULLCompleted18 Years85 YearsAll16Phase 1United States
194EUCTR2016-000637-43-ES
(EUCTR)
06/02/201807/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom
195NCT03189563
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2016-000637-43-AT
(EUCTR)
01/02/201815/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;United Kingdom;Italy
197NCT03329508
(ClinicalTrials.gov)
January 29, 201830/10/2017A Phase 3 Study With P2B001 in Subjects With Early Parkinson'sA Phase 3, Twelve-week Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to Its Individual Components in Subjects With Early Parkinson's Disease and to a Calibration Arm of Pramipexole ER.Parkinson DiseaseDrug: P2B001;Drug: Rasagiline;Drug: Pramipexole;Drug: Pramipexole ERPharma Two B Ltd.NULLRecruiting35 Years80 YearsAll525Phase 3United States;Canada;Germany;Spain
198JPRN-UMIN000030930
2018/01/2901/01/2019Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease.Study on efficacy and safety of the simultaneous treatment with febuxostat and inosine of patients with Parkinson's disease. - Effect of febuxostat and inosine on Parkinson's disease Parkinson's diseaseAdministration of febuxostat 20 mg and inosine 500 mg twice a day for 58 daysStaGen Co. Ltd.NULLComplete: follow-up complete20years-old80years-oldMale and Female30Not selectedJapan
199NCT03331848
(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
200NCT03318523
(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
201NCT03550183
(ClinicalTrials.gov)
January 10, 201811/5/2018Umbilical Cord Derived Mesenchymal Stem Cells Therapy in Parkinson's DiseaseSafety and Efficacy Investigation of Patients With Parkinson's Disease by Transplantation of Umbilical Cord Derived Mesenchymal Stem CellsParkinson's DiseaseBiological: mesenchymal stem cellsHebei Newtherapy BIo-Pharma technology Co., Ltd.NULLEnrolling by invitation40 Years80 YearsAll20Phase 1China
202EUCTR2017-000877-35-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
203NCT03944785
(ClinicalTrials.gov)
November 30, 20171/5/2019Clinical Outcome Assessment of Parkinson's Disease Patients Treated With XADAGO (Safinamide)A Prospective, Observational Study to Evaluate Changes in Non-Motor Symptoms and Other Clinical Outcome Assessments of Parkinson's Disease Patients Treated With XADAGO (Safinamide)TabletsIdiopathic Parkinson DiseaseDrug: XADAGO (safinamide)US WorldMeds LLCNULLCompleted30 Years80 YearsAll209United States
204EUCTR2016-002033-30-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
205NCT03194217
(ClinicalTrials.gov)
November 10, 201719/6/2017BEN-2001 in Parkinson Disease Patients With Excessive Daytime SleepinessDose Finding Phase IIb Study of Bavisant to Evaluate Its Safety and effiCacy in treAtment of exceSsive Daytime sleePiness (EDS) in PARkinson's Disease (PD).Excessive Daytime Sleepiness;Parkinson DiseaseDrug: BEN-2001;Drug: PlaceboBenevolentAI BioNULLCompleted50 Years80 YearsAll244Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2016-002033-30-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
207EUCTR2017-000877-35-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
208NCT03272165
(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
209NCT03205488
(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
210NCT03250117
(ClinicalTrials.gov)
October 10, 201711/8/2017Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral RopiniroleAn Open-Label, Relative Bioavailability Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Ropinirole Implants in Patients With Parkinson's Disease Switched From Oral Immediate-Release Ropinirole While on L-DopaParkinson DiseaseDrug: Ropinirole oral product;Drug: Ropinirole ImplantTitan PharmaceuticalsNULLTerminated30 Years80 YearsAll3Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT04045678
(ClinicalTrials.gov)
October 10, 201730/7/2019A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll30Phase 1China
212EUCTR2017-001673-17-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
213ChiCTR1800019216
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
214NCT03257046
(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
215EUCTR2015-004175-73-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT03295786
(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
217EUCTR2017-000128-81-DE
(EUCTR)
20/09/201706/07/2017PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEPHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE Parkinson’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PF-06649751 - 1mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 5mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 15mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Canada;Spain;Germany
218NCT03306329
(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
219EUCTR2016-003961-25-CZ
(EUCTR)
07/09/201715/05/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3United States;Hungary;Czech Republic;European Union;Canada;Spain;Australia;Germany;United Kingdom
220NCT03272230
(ClinicalTrials.gov)
September 6, 20173/8/2017Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based SystemAssessment of Apathy in a Real-life Situation, With a Video and Sensors-based System in Healthy Subject and Patient With Cerebral DiseaseApathy;Frontotemporal Dementia;Parkinson Disease;Depressive SymptomsBehavioral: ECOCAPTURE;Behavioral: Cognitive and Behavioral experimental tasks;Diagnostic Test: Neuropsychological assessment;Behavioral: ICM_APATHY_TASKS;Other: MRI;Biological: Neurohormonal mechanisms;Diagnostic Test: Supplementary Neuropsychological Assessment - Parkinson's DiseaseInstitut National de la Santé Et de la Recherche Médicale, FranceNULLRecruiting40 Years85 YearsAll135N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2017-000128-81-ES
(EUCTR)
28/08/201712/07/2017PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASEPHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITHMOTOR FLUCTUATIONS DUE TO PARKINSON’S DISEASE Parkinson’s disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000014025;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: PF-06649751 - 1mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 5mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Product Code: PF-06649751 - 15mg
INN or Proposed INN: Not yet assigned
Other descriptive name: PF-06649751
Pfizer Inc., 235 East 42nd Street, New York, New YorkNULLNot RecruitingFemale: yes
Male: yes
198Phase 2France;United States;Canada;Spain;Germany
222EUCTR2017-000877-35-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
223EUCTR2017-000877-35-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
224EUCTR2017-000877-35-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
225NCT03187301
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT03026231
(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
227ChiCTR-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
228NCT03555292
(ClinicalTrials.gov)
July 12, 201724/4/201811C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesSafety and Diagnostic Performance of 11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia SyndromesParkinson DiseaseDrug: 11C-PiBOriental Neurosurgery Evidence-Based-Study TeamNULLRecruiting18 YearsN/AAll200Phase 2China
229EUCTR2017-000135-14-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
230NCT03185481
(ClinicalTrials.gov)
July 6, 20179/6/2017Safety and Tolerability of PF-06649751 in Parkinson's Disease Patients With Motor FluctuationsA PHASE 2, OPEN LABEL EXTENSION STUDY TO INVESTIGATE THE LONG TERM SAFETY AND TOLERABILITY OF PF-06649751 IN SUBJECTS WITH MOTOR FLUCTUATIONS DUE TO PARKINSON'S DISEASEParkinson's Disease With Motor FluctuationsDrug: 1 mg QD to 15 mg QD PF-06649751;Drug: 3 mg QD to 15 mg QD PF-06649751;Drug: 7 mg QD to 15 mg QD PF-06649751;Drug: 15 mg QD PF-06649751;Drug: 1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study);Drug: 3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study);Drug: 15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QDPfizerNULLTerminated40 Years87 YearsAll5Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2015-005814-31-BE
(EUCTR)
06/07/201705/05/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
232NCT03162874
(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
233EUCTR2016-003961-25-DE
(EUCTR)
30/06/201701/02/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
234NCT03042416
(ClinicalTrials.gov)
June 29, 20171/2/201718F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety18F-DOPA PET Imaging: an Evaluation of Biodistribution and SafetyCongenital Hyperinsulinism;Neuroblastoma;Neuroendocrine Tumors;Parkinson Disease;Brain GliomaDrug: 18F-DOPAUniversity of AlbertaAlberta Health ServicesActive, not recruitingN/AN/AAll400Phase 3Canada
235NCT04223245
(ClinicalTrials.gov)
June 29, 20172/12/2019A Home Program Using Multimodal Sensory Feedback for People With Parkinson DiseaseA Comparison Of Home Exercises With Multimodal Real-time Sensory Feedback To The Same Exercise Program With No Enhanced Feedback on Walking Automaticity in People With Parkinson Disease.Parkinson DiseaseBehavioral: exercise+multi-modal sensory feedback (MMSF);Behavioral: Exercise onlyRegis UniversityNULLCompleted21 YearsN/AAll26N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2015-005814-31-ES
(EUCTR)
22/06/201721/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany
237EUCTR2017-000135-14-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
238EUCTR2015-005814-31-HU
(EUCTR)
14/06/201720/04/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 19.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Belgium;Poland;Germany
239EUCTR2016-003961-25-ES
(EUCTR)
08/06/201727/04/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
240EUCTR2017-000135-14-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
241EUCTR2016-003961-25-HU
(EUCTR)
31/05/201703/04/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: tozadenant
Product Code: TOZ
INN or Proposed INN: tozadenant
Other descriptive name: TOZADENANT
Biotie TherapiesNULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;United Kingdom
242EUCTR2017-000135-14-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
243EUCTR2017-000135-14-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
244EUCTR2015-005814-31-PL
(EUCTR)
25/05/201714/02/2017-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
245NCT03033498
(ClinicalTrials.gov)
May 17, 201725/1/2017A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseA Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's DiseaseParkinson's Disease (PD)Drug: ABBV-951AbbVieNULLCompleted45 Years85 YearsAll29Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246NCT03047629
(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
247NCT03065192
(ClinicalTrials.gov)
May 11, 201710/2/2017Safety and Efficacy Study of VY-AADC01 for Advanced Parkinson's DiseaseAn Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Using a Posterior Trajectory Into the Putamen of Participants With Parkinson's Disease With Fluctuating Responses to LevodopaIdiopathic Parkinson's Disease;Parkinson's Disease;Basal Ganglia Disease;Brain Diseases;Central Nervous System Diseases;Movement Disorders;Nervous System Diseases;Neurodegenerative Diseases;Parkinsonian DisordersDrug: VY-AADC01Neurocrine BiosciencesVoyager TherapeuticsActive, not recruiting40 Years75 YearsAll16Phase 1United States
248EUCTR2015-004507-23-FI
(EUCTR)
08/05/201730/03/2017Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
249NCT03119636
(ClinicalTrials.gov)
May 20176/4/2017Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's DiseaseA Phase I/II, Open-Label Study to Assess the Safety and Efficacy of Striatum Transplantation of Human Embryonic Stem Cells-derived Neural Precursor Cells in Patients With Parkinson's DiseaseParkinson's DiseaseBiological: NPC transplantation;Drug: LevodopaChinese Academy of SciencesThe First Affiliated Hospital of Zhengzhou UniversityRecruiting50 Years80 YearsAll50Phase 1;Phase 2China
250NCT03425877
(ClinicalTrials.gov)
April 22, 201710/1/2018Arousal Response Tool for Neurological DiseaseArousal Response Tool for Neurological DiseaseParkinson Disease;Stroke;HealthyDevice: MS Band 2;Behavioral: Emotion Assessment;Behavioral: Single Task;Behavioral: Dual Task;Behavioral: RestIRCCS San Camillo, Venezia, ItalyUniversità Politecnica delle Marche;University of PadovaUnknown status25 YearsN/AAll45N/AItaly
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT03128450
(ClinicalTrials.gov)
April 15, 20179/2/2017A Study To Evaluate the Safety and Efficacy of Human Neural Stem Cells for Parkinson's Disease PatientA Single Arm, Open-Label,Pilot Study to Evaluate the Safety and Efficacy of Human Neural Stem Cells Injection (ANGE-S003) Through Nasal Way Delivery to Patients With Parkinson's DiseaseParkinson DiseaseBiological: human neural stem cellSecond Affiliated Hospital of Soochow UniversityNULLEnrolling by invitation35 Years70 YearsAll12Phase 2;Phase 3China
252NCT03051607
(ClinicalTrials.gov)
April 10, 20179/2/2017Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease.A Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients With Parkinson's Disease Experiencing End of Dose Wearing-OffIdiopathic Parkinson DiseaseDrug: TozadenantBiotie Therapies Inc.Acorda TherapeuticsTerminated30 Years80 YearsAll66Phase 3United States;Canada;United Kingdom
253EUCTR2016-003961-25-GB
(EUCTR)
04/04/201716/02/2017A study to evaluate the safety and tolerability of tozadenant in Parkinson disease patients who are taking levodopa and experiencing wearing offA Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Tozadenant as Adjunctive Therapy in Levodopa-Treated Patients with Parkinson’s Disease Experiencing End of Dose Wearing-Off” Parkinson's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biotie TherapiesNULLNot Recruiting Female: yes
Male: yes
450Phase 3United States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
254NCT02953665
(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
255NCT02970019
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2016-001575-71-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
257EUCTR2015-005814-31-CZ
(EUCTR)
03/03/201701/12/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) - BeyoND Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
210Phase 2France;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
258EUCTR2015-004507-23-HU
(EUCTR)
24/02/201704/01/2017Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
259EUCTR2016-000657-12-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
260EUCTR2015-005814-31-DE
(EUCTR)
07/02/201724/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
170Phase 2United States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2015-004344-19-DE
(EUCTR)
07/02/201727/09/2016An international trial of deferiprone in patients with Parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ApoPharmaNULLNot Recruiting Female: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
262EUCTR2016-000657-12-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
263EUCTR2016-000657-12-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
264NCT02954978
(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
265NCT03037203
(ClinicalTrials.gov)
January 201723/1/2017A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessA 4-Week, Double-blind, Placebo-controlled, Randomized, Multicenter, Crossover Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive SleepinessExcessive Sleepiness;Parkinson DiseaseDrug: JZP-110;Other: PlaceboJazz PharmaceuticalsNULLCompleted35 Years80 YearsAll66Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT02969369
(ClinicalTrials.gov)
December 31, 201617/11/2016A Study to Evaluate the Efficacy, Safety and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisA Multicenter Randomized Double-blind Followed by an Open-label Extension Study to Evaluate the Efficacy, Safety, and Tolerability of SEP-363856 in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: SEP-363856;Drug: Placebo capsuleSunovionNULLCompleted55 Years105 YearsAll39Phase 2United States
267EUCTR2016-001575-71-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
268EUCTR2016-002033-30-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
269NCT02906020
(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
270ChiCTR2000037957
2016-12-012020-09-07Clinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's diseaseClinical study of dexmedetomidine on deep brain stimulation in middle-aged and elderly patients with Parkinson's disease Deep brain stimulation in patients with Parkinson's diseaseExperimental group:conscious sedation with dexmedetomidine;control group:Pump in normal saline;Shanghai Jing'an District Central HospitalNULLCompleted4575BothExperimental group:27;control group:9;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02941822
(ClinicalTrials.gov)
December 20165/9/2016Ambroxol in Disease Modification in Parkinson DiseaseA Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson DiseaseParkinson DiseaseDrug: AmbroxolUniversity College, LondonThe Cure Parkinson's TrustCompleted40 Years80 YearsAll23Phase 2United Kingdom
272NCT03000569
(ClinicalTrials.gov)
November 30, 201628/11/2016A Study to Evaluate SAGE-217 in Participants With Parkinson's DiseaseA Phase 2, Two-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SAGE-217 in Subjects With Parkinson's DiseaseParkinson DiseaseDrug: SAGE-217;Drug: Levodopa;Drug: Antiparkinsonian Agent(s)Sage TherapeuticsNULLCompleted40 Years75 YearsAll29Phase 2United States
273EUCTR2016-002033-30-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
274JPRN-UMIN000024536
2016/11/2825/10/2016Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease.Intervention Study for the effect of Istradefylline on onset of Dyskinesia in Patients with Parkinson's Disease. - ODYSSEI Study(Onset of Dyskinesia and Safety/Efficacy of Istradefylline) Parkinson's diseaseTreatment with istradefylline combined with optimal medical therapy.

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

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

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

After Week 4, Optimal medical therapy without istradefylline will be applied to each patient.
Fukuoka UniversityNULLComplete: follow-up complete30years-old80years-oldMale and Female280Not applicableJapan
275EUCTR2015-004912-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT02847442
(ClinicalTrials.gov)
November 23, 201621/7/2016Efficacy and Safety of Opicapone in Clinical PracticeEfficacy and Safety of Opicapone in Clinical Practice in Parkinson's Disease Patients With Wearing-off Motor FluctuationsParkinson's Disease With Wearing-off Motor FluctuationsDrug: BIA 9-1067;Drug: levodopa/dopa decarboxylase inhibitorBial - Portela C S.A.NULLCompleted30 YearsN/AAll518Phase 4Germany
277EUCTR2016-000657-12-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
278NCT03531060
(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
279EUCTR2016-002033-30-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
280ChiCTR-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT03022799
(ClinicalTrials.gov)
November 201627/12/2016Phase I, KM-819 in Healthy Subjects for Parkinson's DiseaseA First in Human, Randomized, Double-blind, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Single and Multiple Oral Doses of KM-819 in Healthy Young Adult and Elderly SubjectsParkinson's DiseaseDrug: KM-819;Drug: PlaceboKainos Medicine Inc.NULLCompleted19 Years45 YearsAll88Phase 1Korea, Republic of
282EUCTR2015-001786-10-DE
(EUCTR)
24/10/201607/04/2016A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease. A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot Recruiting Female: yes
Male: yes
40Phase 2United States;Germany;United Kingdom
283EUCTR2016-000657-12-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
284NCT02847650
(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
285EUCTR2015-002571-24-GB
(EUCTR)
14/10/201612/02/2019A Pilot Study to Evaluate the Safety, Tolerability (any side effects of the drug) and Pharmacodynamic (biochemical and physiological effects of drugs). The effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease. A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients with Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease - AiM-PD Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Joint Research OfficeNULLNot Recruiting Female: yes
Male: yes
20Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286NCT02728843
(ClinicalTrials.gov)
October 12, 201631/3/2016Study of Parkinson's Early Stage With DeferiproneA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone;Drug: PlaceboApoPharmaNULLCompleted18 Years80 YearsAll140Phase 2Canada;France;Germany;United Kingdom
287EUCTR2016-002391-27-DE
(EUCTR)
05/10/201605/08/2016OPTIPARKEfficacy and safety of opicapone in clinical practice in Parkinson’s Disease patients with wearing-off motor fluctuations Parkinson's disease (PD) patients with wearing-off motor fluctuations;Therapeutic area: Not possible to specifyBIAL - Portela & Ca, S.A.NULLNot Recruiting Female: yes
Male: yes
550Phase 4Germany;United Kingdom
288NCT02538315
(ClinicalTrials.gov)
October 201625/8/2015Using [18F]FDOPA PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease PatientsUsing 3,4-dihydroxy-6-[18F]-Fluoro-l-phenylalanine ( [18F]FDOPA) PET/CT to Monitor the Effectiveness of Fetal Dopaminergic Grafts in Parkinson Disease PatientsParkinson`s DiseaseDrug: [18F]FDOPA PET/CTUniversity of SaskatchewanUniversity of ManitobaRecruiting18 YearsN/AAll30N/ACanada
289EUCTR2015-005078-39-DE
(EUCTR)
21/09/201602/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
290JPRN-UMIN000024312
2016/09/2025/05/2017Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2015-005814-31-AT
(EUCTR)
29/08/201611/05/2016-A multicenter, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's Disease (BeyoND) Subjects with advanced Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 2United States;France;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
292NCT02782481
(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
293NCT02789592
(ClinicalTrials.gov)
July 201631/5/2016Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson DiseaseA Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson DiseaseREM Sleep Behavior Disorder;Parkinson DiseaseDrug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placeboSeoul National University HospitalKuhnil Pharmaceutical Co., Ltd.Not yet recruiting30 YearsN/ABoth30Phase 2Korea, Republic of
294NCT02452723
(ClinicalTrials.gov)
July 201618/5/2015A Study to Evaluate the Safety of Neural Stem Cells in Patients With Parkinson's DiseaseA Single Arm, Open-Label Phase 1 Study to Evaluate the Safety and Tolerability of ISC-hpNSC Injected Into the Striatum and Substantia Nigra of Patients With Parkinson's DiseaseParkinson DiseaseBiological: ISC-hpNSCCyto Therapeutics Pty LimitedNULLActive, not recruiting30 Years70 YearsAll12Phase 1Australia
295EUCTR2015-004344-19-FR
(EUCTR)
29/06/201620/04/2016An international trial of deferiprone in patients with parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ApoPharma Inc.NULLNot Recruiting Female: yes
Male: yes
140Phase 2United States;France;Canada;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
296EUCTR2015-005626-19-CZ
(EUCTR)
23/06/201614/04/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 20.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301 35mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301 50mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Czech Republic;Canada;Poland;Spain
297EUCTR2015-003512-20-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
298EUCTR2015-004912-39-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
299EUCTR2015-005626-19-ES
(EUCTR)
13/06/201620/04/2016A study of the safety and effectiveness of levodopa inhalation powder (CVT-301) in Parkinson's Disease Patients with OFF episodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT-301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena) Parkinson's Disease With Motor Response Fluctuations (OFF Phenomena)
MedDRA version: 19.0;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CVT-301
Product Code: CVT-301 35mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Product Name: CVT-301
Product Code: CVT-301 50mg
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
Civitas Therapeutics, a wholly owned subsidiary of AcordaNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Czech Republic;Canada;Poland;Spain
300EUCTR2015-003512-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301NCT02807675
(ClinicalTrials.gov)
June 201617/6/2016A Study of the Safety and Tolerability of a Single Dose Administration of CVT-301 (Levodopa Inhalation Powder)A Phase 1 Study of the Safety and Tolerability of a Single Dose Administration of CVT- 301 (Levodopa Inhalation Powder) When Administered for Early Morning OFF Symptoms in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301, LIP;Other: PlaceboAcorda TherapeuticsNULLCompleted30 Years85 YearsAll36Phase 1United States
302EUCTR2016-000679-25-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
303JPRN-UMIN000009062
2016/05/3009/10/2012An open-label, single-centered, non-randomized trial of inosine to assess its safety for patients with Parkinson's disease Parkinson's diseaseTake oral inosine 500-3000mg/day to achieve a serum UA level between 6.0-8.0 mg/dLDept. of Clinical pharmacology and NeurologyNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Phase 1Japan
304EUCTR2015-005078-39-AT
(EUCTR)
30/05/201609/03/2016-A multicenter, parallel-group, rater-blinded, randomized clinical study investigating the efficacy, safety, tolerability and pharmacokinetics of 2 dosing regimens of ND0612H, a solution of levodopa/carbidopa delivered via a pump system as a continuous subcutaneous infusion in subjects with advanced Parkinson's disease Subjects with advanced Parkinson's disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: levodopa/carbidopa solution
Product Code: ND0612
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
47Phase 2United States;Austria;Israel;Germany;Italy
305EUCTR2015-003512-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2016-000636-18-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
307EUCTR2016-000637-43-GB
(EUCTR)
12/05/201604/03/2016Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;France;Canada;Spain;Austria;Germany;Italy;United Kingdom
308JPRN-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
309JPRN-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
310EUCTR2015-003512-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311NCT02726386
(ClinicalTrials.gov)
May 201629/3/2016A Clinical Study in Advanced Parkinson's Disease Investigating the Long Term Safety of ND0612 Administered as a Continuous SC InfusionA Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612NeuroDerm Ltd.NULLActive, not recruiting30 YearsN/AAll210Phase 2United States;Austria;Czechia;France;Germany;Israel;Italy;Poland;Spain
312NCT02784145
(ClinicalTrials.gov)
May 201617/5/2016Effects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseEffects of Resistant Starch on Bowel Habits, Fecal Short Chain Fatty Acids and Gut Microbiota in Parkinson DiseaseParkinson DiseaseDietary Supplement: Resistant starch;Other: Recommendation with regard to nutritionSaarland UniversityNULLCompleted18 YearsN/AAll95N/AGermany
313EUCTR2015-003512-20-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
314EUCTR2015-004507-23-DE
(EUCTR)
25/04/201613/01/2016Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson’s disease and end-of-dose wearing-off. - COMPOC Parkinson’s disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
80Phase 2Hungary;Finland;Latvia;Germany
315EUCTR2015-003512-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2014-005630-60-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
317NCT02764125
(ClinicalTrials.gov)
April 8, 201613/1/2016Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)Efficacy and Safety of ODM-104 Compared to a Standard Combination (Stalevo®); a Randomized Double-blind, Crossover Proof-of-concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-offParkinson's DiseaseDrug: Stalevo;Drug: levodopa MROrion Corporation, Orion PharmaNULLCompleted30 YearsN/AAll84Phase 2Finland;Germany;Hungary;Latvia
318EUCTR2015-005067-17-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
319NCT02719496
(ClinicalTrials.gov)
April 201615/3/2016Prove of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseProve of Concept Study, to Evaluate the Efficacy, Safety, and Tolerability of IBEROGAST in the Treatment of Bowel Troubles in Patients With Parkinson's DiseaseGastrointestinal Disorders in Parkinson's DiseaseDrug: IBEROGASTNantes University HospitalNULLCompleted30 Years80 YearsAll45Phase 2France
320NCT02775591
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2015-004344-19-GB
(EUCTR)
31/03/201616/02/2016An international trial of deferiprone in patients with Parkinson’s diseaseA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients with Parkinson’s Disease - LA48-0215 Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Deferiprone 600 mg delayed release tablet
INN or Proposed INN: DEFERIPRONE
ApoPharmaNULLNot RecruitingFemale: yes
Male: yes
140Phase 2France;Canada;Germany;United Kingdom
322NCT02462603
(ClinicalTrials.gov)
March 31, 201620/5/2015Safety and Biomarker Study of EPI-589 in Parkinson's DiseaseA Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson's Disease SubjectsParkinson's DiseaseDrug: EPI-589PTC TherapeuticsNULLCompleted21 Years75 YearsAll44Phase 2United States;Germany;United Kingdom
323EUCTR2015-004507-23-LV
(EUCTR)
15/03/201613/01/2016Comparison of two levodopa treatments, ODM-104 and Stalevo, in Parkinson's disease patients who have motor fluctuations.Efficacy and safety of ODM-104 compared to a standard combination (Stalevo); a randomised, double-blind, crossover proof-of-concept study in patients with Parkinson's disease and end-of-dose wearing-off. - COMPOC Parkinson's disease (PD) patients with end-of-dose wearing-off (motor fluctuations);Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]Product Name: Levodopa 75 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 100 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 125 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Levodopa 150 mg A CAP
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Product Name: Carbidopa 65 mg capsule
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Product Name: ODM-104
INN or Proposed INN: na
Other descriptive name: ODM-104
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Finland;Germany;Latvia
324EUCTR2015-005067-17-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
325NCT02687542
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
326NCT02605434
(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
327NCT02618941
(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
328NCT04569656
(ClinicalTrials.gov)
February 2, 201624/9/2020Treatment of Chronic Constipation in Parkinson's DiseasePilot Study for the Evaluation of the Parameters of Activity of a Preparation of PHGG and Sodium Hyaluronate in Chronic Constipation in Patients With Parkinson's DiseaseParkinson DiseaseDrug: hydrolyzed guar gumIRCCS San RaffaeleNULLCompleted18 YearsN/AAll34Phase 2Italy
329NCT02683629
(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
330EUCTR2015-001786-10-GB
(EUCTR)
18/01/201623/11/2015A clinical study of the effects of EPI-589 on safety and indicators of oxidative stress in patients with Parkinson's disease.A Phase 2A Safety and Biomarker Study of EPI-589 in Mitochondrial Subtype and Idiopathic Parkinson’s Disease Subjects - Safety and Biomarker Study with EPI-589 in Parkinson's Disease Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: EPI-589
Product Code: EPI-589
Other descriptive name: (R)-troloxamide quinone
BioElectron Technology Corporation (formerly Edison Pharmaceuticals Inc.)NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United States;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331NCT02579473
(ClinicalTrials.gov)
January 201613/10/2015A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214A Multi-center, Open-label, Multiple Ascending Dosage-ranging Cohort (MAD) Study in Early, Untreated or Stably Treated Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetics (PK) of Injections of SER-214 Administered Subcutaneously Once a Week for Two Weeks After 0-2 Weeks of Dose TitrationParkinson's DiseaseDrug: SER-214Serina TherapeuticsNULLActive, not recruiting40 Years80 YearsAll20Phase 1United States
332NCT02649608
(ClinicalTrials.gov)
January 20166/1/2016An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease PatientsInterventional, Open-label, Exploratory Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Lu AE04621 and the Active Metabolite Lu AA40326 After Ascending Oral Doses of Lu AE04621 to Patients With Parkinson's DiseaseParkinson DiseaseDrug: 0.04 mg Lu AE04621;Drug: 0.08 mg Lu AE04621;Drug: 0.2 mg Lu AE04621;Drug: 0.4 mg Lu AE04621;Drug: 0.6 mg Lu AE04621;Drug: 0.8 mg Lu AE04621;Drug: 1.0 mg Lu AE04621;Drug: 1.2 mg Lu AE04621H. Lundbeck A/SNULLCompleted45 Years75 YearsAll15Phase 1United States
333NCT02639221
(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
334EUCTR2014-002600-24-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
335JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336EUCTR2014-005630-60-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
337EUCTR2014-002600-24-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
338EUCTR2014-002600-24-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
339NCT02616120
(ClinicalTrials.gov)
December 201520/11/2015Effect of SQJZ Herbal Mixtures on Non-motor Symptoms of Parkinson's DiseaseEfficacy and Safety of SQJZ Herbal Mixtures on Non-motor Symptoms in Parkinson's Disease PatientsParkinson's DiseaseDrug: SQJZ herbal mixtures;Drug: PlaceboDongzhimen Hospital, BeijingNULLRecruiting18 Years80 YearsAll240Phase 2China
340JPRN-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2014-002600-24-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
342EUCTR2015-002631-17-ES
(EUCTR)
19/11/201503/11/2015A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patientsAn intra-subject, randomized, double blind, crossover study comparing immediate-release oral LD (IR-LD) and L-dopa/carbidopa intestinal gel (LCIG) over cognition and mood in non-demented advanced Parkinson?s disease (PD) patients Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Institut de Recerca del Hospital de la Santa Creu i Sant PauNULLNot Recruiting Female: yes
Male: yes
18Phase 4Spain
343NCT02565628
(ClinicalTrials.gov)
November 16, 201528/9/2015PF-06669571 In Subjects With Idiopathic Parkinson's DiseaseA Phase 1b, Double Blind, Sponsor Open, Randomized, Parallel, Group Multiple Dose Study Examining The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06669571 In Subjects With Idiopathic Parkinson's Disease.Idiopathic Parkinson's DiseaseDrug: PF-06669571;Drug: PlaceboPfizerNULLCompletedN/AN/AAll20Phase 1United States
344EUCTR2014-002600-24-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
345NCT02577523
(ClinicalTrials.gov)
November 20156/10/2015A Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of ND0612H, a Solution of Levodopa/Carbidopa Administered as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseA Multicenter, Parallel-group, Rater-blinded, Randomized Clinical Study Investigating the Efficacy, Safety, Tolerability and Pharmacokinetics of 2 Dosing Regimens of ND0612H, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: ND0612 (Levodopa/Carbidopa solution)NeuroDerm Ltd.NULLCompleted30 Years80 YearsAll38Phase 2United States;Austria;Israel;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
346NCT02758730
(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
347EUCTR2014-005630-60-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
348NCT02572713
(ClinicalTrials.gov)
October 20157/10/2015Systemic Synuclein Sampling Study (S4)Systemic Synuclein Sampling Study (S4)Parkinson's DiseaseProcedure: Biofluid samplings;Procedure: Tissue samplings;Drug: DaTSCANMichael J. Fox Foundation for Parkinson's ResearchIndiana University;University of Iowa;Banner Health;Paracelsus Elena KlinikCompleted40 YearsN/AAll80N/AUnited States;Canada
349NCT02562768
(ClinicalTrials.gov)
September 30, 201528/9/2015A Study of LY3154207 in Healthy Participants and Participants With Parkinson's DiseaseMultiple-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3154207 in Healthy Subjects and Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: LY3154207;Drug: PlaceboEli Lilly and CompanyNULLCompleted20 YearsN/AAll80Phase 1United States
350EUCTR2014-005630-60-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
351NCT02542696
(ClinicalTrials.gov)
August 31, 20153/9/2015Open-Label Phase 3 Study to Examine the Long-Term Safety, Tolerability and Efficacy of APL-130277 for the Acute Treatment of OFF Episodes in Patients With Parkinson's DiseaseAn Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)Parkinson DiseaseDrug: APL-130277SunovionNULLRecruiting18 YearsN/AAll226Phase 3United States;Austria;Canada;France;Germany;Italy;Spain;United Kingdom
352EUCTR2015-000373-13-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
353NCT02337751
(ClinicalTrials.gov)
July 10, 20159/1/2015A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With LevodopaParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll198Phase 3Japan
354NCT02459886
(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
355NCT02488265
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
356NCT02415062
(ClinicalTrials.gov)
July 201514/3/2015The Efficacy and Safety Study of High Dose Donepezil in Parkinson's Disease With DementiaThe Efficacy of 23mg Versus 10mg of Donepezil in ParkInson's Disease With DementiaParkinson's DiseaseDrug: DonepezilInje UniversityNULLRecruiting50 Years80 YearsBoth150Phase 2Korea, Republic of
357NCT02453386
(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
358EUCTR2014-003738-24-AT
(EUCTR)
26/06/201501/04/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 17.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3Germany;Spain;Austria;United States
359EUCTR2014-003739-20-AT
(EUCTR)
19/06/201501/04/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Spain;Austria;Germany
360NCT02469090
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
361EUCTR2014-003799-22-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
362EUCTR2010-024424-26-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
363NCT02439203
(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
364NCT02439125
(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
365EUCTR2014-003738-24-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
366EUCTR2014-003739-20-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Adamas Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
250Phase 3France;United States;Spain;Austria;Germany
367EUCTR2014-003799-22-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
368EUCTR2014-003739-20-FR
(EUCTR)
10/04/201519/06/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Adamas Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
200Phase 3United States;France;Spain;Austria;Germany
369EUCTR2014-003739-20-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's diseaseOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa-Induced Dyskinesia Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Spain;Austria;Germany
370EUCTR2014-003738-24-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
371EUCTR2014-003799-22-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
372NCT02242487
(ClinicalTrials.gov)
March 201515/9/2014Twelve Month Safety and Efficacy Study of CVT-301 In Parkinson's Disease Patients With OFF EpisodesA 12 Month, Dose-Level Blinded Study Investigating the Safety and Efficacy of CVT 301 (Levodopa Inhalation Powder) in Parkinson's Disease Patients With Motor Response Fluctuations (OFF Phenomena)Idiopathic Parkinson's DiseaseDrug: CVT-301Acorda TherapeuticsNULLCompleted30 Years86 YearsAll325Phase 3United States;Canada;Czechia;Poland;Spain;Czech Republic
373NCT02066571
(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
374NCT02373072
(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
375NCT02696603
(ClinicalTrials.gov)
March 201523/2/2016Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)Mobile Parkinson Observatory for Worldwide, Evidence-based Research (mPower)Parkinson Disease;Neurodegenerative Diseases;Movement Disorders;Central Nervous System Diseases;Brain Diseases;Basal Ganglia Diseases;Parkinsonian DisordersBehavioral: Participant self-assessment surveys;Behavioral: Phonation;Behavioral: Gait and balance;Behavioral: Memory;Behavioral: Dexterity;Behavioral: Participant open-response writing;Other: Parkinson mPower mobile applicationSage BionetworksRobert Wood Johnson FoundationRecruiting18 YearsN/AAll20000N/AUnited States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
376NCT02352363
(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
377EUCTR2014-003799-22-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
378EUCTR2014-003799-22-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
379NCT02337725
(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
380NCT02337764
(ClinicalTrials.gov)
February 3, 20159/1/2015A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease ParticipantsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease PatientsParkinson's DiseaseDrug: TVP-1012 1mgTakedaNULLCompleted30 Years79 YearsAll222Phase 3Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
381EUCTR2014-003799-22-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
382NCT02339064
(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
383NCT02337738
(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
384JPRN-JapicCTI-152762
27/1/2015A long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease PatientsA Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients Parkinson's diseaseIntervention name : TVP-1012 (1 mg/day) with levodopa
Dosage And administration of the intervention : TVP-1012 (1 mg/day) once daily, before or after breakfast. A levodopa combination drug will be concomitantly administered in principle without change in the dose regimen throughout the study period from the start of the screening period.
Control intervention name : null
TAKEDA PHARMACEUTICAL COMPANY LTD.NULL3079BOTH215Phase 3NULL
385EUCTR2014-003799-22-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
386NCT02347059
(ClinicalTrials.gov)
January 201520/1/2015L-dopa Versus Dopamine Agonists After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's DiseaseA Randomized, Single-blind Trial on the Efficacy and Safety of L-dopa Monotherapy Versus Dopamine Agonists Monotherapy After Subthalamic Nucleus Deep Brain Stimulation in Parkinson's DiseaseParkinson's DiseaseDrug: L-dopa;Drug: Dopamine Agonists (pramipexole, ropirinole)University of TorontoMichael J. Fox Foundation for Parkinson's ResearchRecruitingN/AN/ABoth40Phase 2Canada
387NCT02763137
(ClinicalTrials.gov)
January 201526/4/2016Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian PatientsA Phase IIa Study to Assess the Safety, Tolerability, Plasma Pharmacokinetics and Efficacy of Intermittent Oral Administration of Standard Levodopa/Carbidopa vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Patients With Advanced Parkinson's Disease Who Suffer Motor FluctuationsParkinson DiseaseDrug: Standard LD/CD;Drug: Semi continuous intra-oral administration of LD/CDIRCCS San RaffaeleSynAgile CorporationCompleted35 Years75 YearsBoth18Phase 2Italy
388NCT02258152
(ClinicalTrials.gov)
December 22, 20143/10/2014SYN120 Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)SYN120 a Dual 5-HT6/5-HT2A Antagonist Proof of Concept Study to Evaluate Its Safety, Tolerability and Efficacy in Parkinson's Disease Dementia (SYNAPSE)Parkinson's Disease Dementia (PDD)Drug: SYN120;Drug: PlaceboBiotie Therapies Inc.Michael J. Fox Foundation for Parkinson's Research;Massachusetts General Hospital;Acorda TherapeuticsCompleted50 YearsN/AAll82Phase 2United States
389NCT02267434
(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
390EUCTR2014-001132-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
391NCT02240030
(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
392EUCTR2014-001132-10-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
393EUCTR2014-001131-36-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
394EUCTR2014-002295-87-IT
(EUCTR)
13/10/201429/09/2014A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations.A Phase IIa study to assess the safety, tolerability, plasma pharmacokinetics and efficacy of intermittent oral administration of standard levodopa/carbidopa vs. semi-continuous intra-oral administration of levodopa/carbidopa in patients with advanced Parkinson’s disease who suffer motor fluctuations. Parkinson's disease patients who suffer motor fluctuations willparticipate in the study
MedDRA version: 17.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 100 mg + 25 mg compresse
Product Name: SINEMET 100 mg + 25 mg compresse
Product Code: NA
SynAgile CorporationNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Italy
395NCT02224664
(ClinicalTrials.gov)
October 201415/8/2014Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson`s DiseaseA Phase 1b, 2-period, Open Label, Multicenter, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06649751 In Subjects With Parkinson`s Disease And Motor FluctuationsParkinson`s DiseaseDrug: PF-06649751PfizerNULLCompleted30 Years80 YearsAll50Phase 1United States;Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
396NCT02274766
(ClinicalTrials.gov)
October 201422/10/2014Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced DyskinesiaADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll77Phase 3United States;Austria;France;Germany;Spain
397NCT03151460
(ClinicalTrials.gov)
September 20149/5/2017Dopaminergic Modulation of Declarative MemoryDopaminergic Modulation of Declarative MemoryParkinson's DiseaseDrug: Dopamine AgentI.R.C.C.S. Fondazione Santa LuciaNULLCompletedN/AN/AAll40Phase 4Italy
398NCT02225548
(ClinicalTrials.gov)
September 201422/8/2014Sagene 2014 - Parkinson's Disease and Erectile DysfunctionAn Open-label Trial of Oral Selegiline 5 or 10 mg and Tadalafil 2.5mg Co-administration to Male Patients With Parkinson's Disease and Moderate Erectile Dysfunction.Parkinson's Disease;Erectile DysfunctionDrug: Selegiline;Drug: TadalafilUniversity of South FloridaNULLRecruiting40 Years64 YearsMale10Phase 4United States
399NCT02228590
(ClinicalTrials.gov)
August 31, 201426/8/2014A Study to Examine APL-130277 in Patients With Parkinson's DiseaseA Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: APL-130277SunovionNULLCompleted18 Years80 YearsAll20Phase 2United States
400NCT02153645
(ClinicalTrials.gov)
August 18, 201430/5/2014Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesias (LID)Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tabletsOsmotica Pharmaceutical US LLCNULLTerminated30 Years85 YearsAll87Phase 3United States;Canada;France;Germany;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
401NCT02216188
(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
402NCT02153632
(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
403NCT02202551
(ClinicalTrials.gov)
July 201425/7/2014Open-Label Safety Study of ADS-5102 in PD Patients With LIDOpen-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll223Phase 3United States;Austria;Canada;France;Germany;Spain
404EUCTR2013-000980-10-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
405NCT02136914
(ClinicalTrials.gov)
May 20149/5/2014ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's DiseaseDrug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll126Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
406EUCTR2012-005539-10-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
407EUCTR2013-002254-70-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
408NCT03314597
(ClinicalTrials.gov)
April 2, 201415/10/2017Instrumental or Physical-Exercise Rehabilitation of Balance in Parkinson's Disease? (IPER-PD)Instrumental or Physical-exercise Rehabilitation of Balance Improve Both Balance and Gait in Parkinson's Disease.Parkinson's Disease;RehabilitationOther: Balance exercise;Other: Mobile platform exerciseUniversity of PaviaFondazione Salvatore MaugeriCompleted50 Years85 YearsAll38N/ANULL
409NCT02741947
(ClinicalTrials.gov)
April 201431/3/2016Levodopa Benserazide Generic Formulation Versus the OriginatorClinical and Pharmacokinetics Study to Evaluate the Therapeutic Equivalence and Bioequivalence of Levodopa Benserazide Generic Formulation (Teva Italia) Versus the Originator (Madopar®)Parkinson DiseaseDrug: Levodopa Benserazide Madopar;Drug: Levodopa Benserazide Teva ItaliaIRCCS San RaffaeleAgenzia Italiana del FarmacoCompleted30 Years75 YearsBoth44Phase 4Italy
410NCT02091739
(ClinicalTrials.gov)
April 201418/3/2014Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsProspective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological ConditionsChronic Troublesome Sialorrhea;Parkinson's Disease;Post-stroke;Traumatic Brain InjuryDrug: IncobotulinumtoxinA (100 Units);Drug: IncobotulinumtoxinA (75 Units);Drug: PlaceboMerz Pharmaceuticals GmbHNULLCompleted18 Years80 YearsAll184Phase 3Germany;Poland;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
411NCT02082249
(ClinicalTrials.gov)
March 10, 201414/2/2014An Extension Study to Assess the Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAn Open-Label Three-Part Extension Study Assessing Safety, Tolerability and Efficacy of ABT-SLV187 in Subjects With Advanced Parkinson's Disease and Persistent Motor-Complications Despite Optimized Treatment With Available Anti-Parkinsonian MedicationsAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLCompleted30 Years99 YearsAll23Phase 3Japan;Korea, Republic of;Taiwan
412EUCTR2013-002254-70-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
413NCT02006121
(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
414EUCTR2013-000980-10-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
415NCT02006290
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
416NCT02111330
(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
417EUCTR2013-002254-70-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
418EUCTR2013-002254-70-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
419EUCTR2013-000980-10-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
420EUCTR2013-000980-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
421EUCTR2013-002545-10-SE
(EUCTR)
08/01/201411/11/2013An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy.An open safety study with the monoaminergic stabilizer (-)-OSU6162 in patients with mental fatigue and related vitality and wakefulness disturbances associated with neurologiacal disorders, e g Parkinson’s disease, Huntington’s disease, brain trauma, stroke, myalgic encephalomyelitis and narcolepsy. - OSU6162Open1309 Parkinsons diseaseHuntingtons diseaseMultiple sclerosBrain traumaStrokeMyalgic encephalomyelitisNarcolepsy;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: OSU6162 similar to (-)-OSU 6162A. Carlsson Research ABNULLNot RecruitingFemale: yes
Male: yes
240Phase 2Sweden
422NCT01968460
(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
423NCT01883505
(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
424NCT02018406
(ClinicalTrials.gov)
December 201330/10/2013Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain InjuryNeurological Diseases;Ischemic Stroke;Hemorrhagic Stroke;Cerebral Palsy;Atypical Parkinson DiseaseDrug: Combination injection of EPO and G-CSF;Drug: Injection of normal salineYonsei UniversityNULLActive, not recruiting20 YearsN/AAll16Phase 1;Phase 2Korea, Republic of
425NCT04044547
(ClinicalTrials.gov)
November 22, 201330/7/2019A Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll60Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
426EUCTR2013-000980-10-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
427NCT01960842
(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
428NCT02055274
(ClinicalTrials.gov)
October 201331/1/2014Pharmacokinetics and Safety Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson's DiseaseDrug: LY03003;Drug: NeuproLuye Pharma Group Ltd.NULLCompleted18 YearsN/ABoth39Phase 1United States
429NCT01973543
(ClinicalTrials.gov)
October 201325/10/2013Safety Study of AADC Gene Therapy (VY-AADC01) for Parkinson's DiseaseAn Open-label Safety and Efficacy Study of VY-AADC01 Administered by MRI-Guided Convective Infusion Into the Putamen of Subjects With Parkinson's Disease With Fluctuating Responses to LevodopaParkinson's DiseaseBiological: VY-AADC01Neurocrine BiosciencesUniversity of California, San Francisco;Veristat, Inc.;Feinstein Institute for Medical Research;Oregon Health and Science University;Voyager TherapeuticsCompleted40 Years70 YearsAll15Phase 1United States
430EUCTR2013-001881-40-GB
(EUCTR)
16/09/201305/08/2013Extension study to Assess the Benefit and Safety of Administering Intermittent GDNF Infusions in Parkinson's Disease (PD)An Extension Study to Assess the Safety and Efficacy of Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via onvection Enhanced Delivery (CED) in Subjects with Parkinson’s Disease - Intermittent Bilateral GDNF for Parkinson’s Disease Parkinson's disease
MedDRA version: 18.1;Level: LLT;Classification code 10034008;Term: Parkinson's syndrome;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
North Bristol NHS Trust (NBT)NULLNot Recruiting Female: yes
Male: yes
42Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
431NCT01882010
(ClinicalTrials.gov)
September 201313/6/2013Leukine (Sargramostim) for Parkinson's DiseaseLeukine (Sargramostim) for Parkinson's DiseaseParkinson's DiseaseProcedure: blood draw;Procedure: physical exam and UPDRS part III assessment;Procedure: MEG;Drug: sargramostim;Drug: placebo;Behavioral: physical exam and UPDRS part III assessment;Procedure: Motion AnalysisHoward Gendelman, MDSanofi;National Institute of Neurological Disorders and Stroke (NINDS);UNeMed;Nebraska Neuroscience AllianceCompleted35 Years85 YearsBoth37Phase 1United States
432NCT01955616
(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
433NCT01767129
(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
434NCT01879748
(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
435NCT01765257
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
436NCT02263235
(ClinicalTrials.gov)
June 201318/9/2014In Vivo Alzheimer ProteomicsUse of Targeted Quantitative Proteomics and Metabolic Labelling With Stable Isotopes for the Diagnosis and the Investigation of Neurological Disorders and in Particular Alzheimer DiseaseProbable Alzheimer Disease;Parkinson Disease;Neurological Disease Without Cognitive Degradation;Brain Trauma;Acute HydrocephalyBiological: administration of stable isotope-labelled leucine-;Other: collection of CSF, blood, urine, salivaUniversity Hospital, MontpellierAssistance Publique - Hôpitaux de Paris;University Hospital, Clermont-Ferrand;International Atomic Energy AgencyRecruiting55 Years85 YearsBoth110N/AFrance
437JPRN-UMIN000010752
2013/05/1717/05/2013A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia. Parkinson's diseasedonepezilKansai Medical UniversityNULLComplete: follow-up completeNot applicableNot applicableMale and Female50Not selectedJapan
438EUCTR2012-005822-31-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
439NCT02500108
(ClinicalTrials.gov)
May 201314/7/2015Domperidone and Risk of Sudden Cardiac DeathDomperidone Use in Parkinson's Disease and Risk of Sudden Cardiac DeathParkinson's DiseaseDrug: DomperidoneCanadian Network for Observational Drug Effect Studies, CNODESDrug Safety and Effectiveness Network, Canada;Canadian Institutes of Health Research (CIHR)Completed50 YearsN/ABoth214962N/ACanada
440NCT01860794
(ClinicalTrials.gov)
May 201314/5/2013Evaluation of Safety and Tolerability of Fetal Mesencephalic Dopamine Neuronal Precursor Cells for Parkinson's DiseaseInvestigator Clinical Trial for Evaluation of Safety and Tolerability After Transplantation of Fetal Mesencephalic Dopamine Neuronal Precursor Cells in Patients With Parkinson's DiseaseIdiopathic Parkinson Disease;Primary ParkinsonismDrug: Mesencephalic Neuronal Precursor CellsBundang CHA HospitalNULLRecruiting18 Years70 YearsFemale15Phase 1;Phase 2Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
441NCT03022201
(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
442EUCTR2012-005822-31-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
443NCT01777555
(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
444NCT01829867
(ClinicalTrials.gov)
April 20139/4/2013A Study With an Increased Dose Step in Patients That Have Previously Received Placebo or sNN0031.A Phase I, Open-label Study in Patients With Parkinson's Disease to Further Assess Safety and Tolerability of sNN0031 Administered at the Total Dose of 95 µg by Intracerebroventricular InfusionParkinson's DiseaseDrug: sNN0031Newron Sweden ABNULLTerminated55 Years75 YearsBoth5Phase 1Sweden
445NCT01736176
(ClinicalTrials.gov)
March 201327/11/2012A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's DiseaseAn Open-Label, Two Part, Multicenter Study to Assess the Safety and Efficacy of Levodopa-Carbidopa Intestinal Gel (LCIG) for the Treatment of Non-Motor Symptoms in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) TabletsAbbVie (prior sponsor, Abbott)NULLCompleted30 YearsN/AAll39Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
446JPRN-UMIN000017695
2013/01/0127/05/2015Oxybuprocaine for apraxia of lid opening in Parkinson's disease apraxia of lid opening in Parkinson's diseaseArm 1 intervention consisted of 4%oxybuprocaine eye drop treatment, washout for 24 hours or more, and a saline eye drop treatment
Arm 2 intervention consisted of saline eye drop treatment, a washout period, and an oxybuprocaine treatment
Utano National Hospital, National Hospital OrganizationNULLComplete: follow-up completeNot applicableNot applicableMale and Female10Not selectedJapan
447NCT01803945
(ClinicalTrials.gov)
January 201326/2/2013A Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's DiseaseA Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AVE8112 in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: AVE8112;Drug: PlaceboMichael J. Fox Foundation for Parkinson's ResearchSanofiTerminated35 Years70 YearsBoth32Phase 1United States
448NCT01770145
(ClinicalTrials.gov)
December 20127/1/2013Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)A Phase 4, Open-Label, Efficacy and Safety Study of Apokyn® for Rapid and Reliable Improvement of Motor Symptoms in Parkinson Disease Subjects With Delayed Onset of L-Dopa ActionParkinson's Disease;Motor Symptoms;Akinesia;Hypomobility;Delayed Levodopa OnsetDrug: APOKYN;Drug: L-dopa;Drug: TrimethobenzamideUS WorldMeds LLCNULLCompleted18 YearsN/AAll127Phase 4United States
449NCT01725802
(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
450NCT01683253
(ClinicalTrials.gov)
November 20127/9/2012Remission of ICD by Switching Dopamine Agonist to Levodopa/CarbidopaThe REmission of the Impulse Control Disorder and the Changes of the Neuropsychiatric Characteristics After Switching Into Levodopa/Carbidopa in Patients With Parkinson's Disease Who Have Developed Impulse Control Disorders Due to the Dopamine Replacement TherapyImpulse Control DisorderDrug: Levodopa/Carbidopa(200mg/50mg);Drug: Dopaminergic AgonistsSandozNULLCompleted30 Years80 YearsAll150Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
451NCT03652363
(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
452JPRN-UMIN000009099
2012/10/0112/10/2012The effect of lidocaine injection into the external oblique in Parkinson's disease patients with upper camptorcormia Parkinson's diseaselidocaine injection into the external oblique
normal saline injection into the external oblique
Parkinson's disease and Movement Disorder CenterNULLRecruiting20years-oldNot applicableMale and Female10Not applicableJapan
453NCT01603069
(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
454NCT01691924
(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
455NCT01723904
(ClinicalTrials.gov)
October 20126/11/2012A Phase 3b, Open-Label, Safety and Efficacy Study of Rotigotine as Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's DiseaseAn Open-Label Study to Investigate the Safety and Efficacy of Rotigotine Add-On Therapy With Low Doses of Pramipexole or Ropinirole in Patients With Advanced Parkinson's Disease Phase 3BAdvanced Parkinson's DiseaseDrug: RotigotineUCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.Completed30 Years80 YearsAll90Phase 3Australia;Korea, Republic of;Malaysia;Singapore;Taiwan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
456EUCTR2011-003866-34-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
457EUCTR2011-004378-27-AT
(EUCTR)
04/09/201220/07/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
458NCT00947037
(ClinicalTrials.gov)
August 201224/7/2009Gastric Retentive Carbidopa/ Levodopa in Parkinson's Patients; a One Year, Open Label, Safety Extension StudyAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease SubjectsParkinson's DiseaseDrug: AP-CD/LDIntec Pharma Ltd.NULLWithdrawn30 Years95 YearsBoth0Phase 2Israel
459NCT02419313
(ClinicalTrials.gov)
August 201227/1/2014Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized ApproachInvestigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Disease Tremor: A Customized ApproachParkinson;TremorDrug: incobotulinumtoxinA;Drug: SalineYale UniversityNULLCompleted18 YearsN/AAll33Phase 2United States
460JPRN-UMIN000008138
2012/07/0101/07/2012Efficacy and safety of silodosin on lower urinary tract symptoms (LUTS) in patients with Parkinson's disease Parkinson's diseaseSilodosin 8mg BIDJuntendo University School of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale100Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
461NCT01646268
(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
462NCT01646255
(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
463NCT01398748
(ClinicalTrials.gov)
July 201219/7/2011Intranasal Glutathione in Parkinson's DiseaseA Phase 1 Study of Intranasal Reduced Glutathione in Parkinson's DiseaseParkinson's Disease (PD)Drug: Intranasal glutathione - (in)GSH;Drug: Saline Intranasal DeliveryBastyr UniversityNational Center for Complementary and Integrative Health (NCCIH)Completed21 Years100 YearsAll34Phase 1United States
464EUCTR2011-002074-23-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
465EUCTR2012-001218-40-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
466EUCTR2011-004378-27-DE
(EUCTR)
15/05/201224/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
467EUCTR2011-004378-27-SK
(EUCTR)
02/05/201212/04/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
468NCT01617135
(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
469EUCTR2012-000181-37-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
470NCT01486628
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
471NCT01331122
(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
472NCT01550484
(ClinicalTrials.gov)
April 20126/3/2012A Trial of 18F-AV-133 Positron Emission Tomography (PET) Imaging to Differentiate Subjects With Parkinson's Disease (PD) From Other Movement DisordersAn Open Label, Multicenter Study, Evaluating the Safety and Efficacy of 18F-AV-133 PET Imaging to Identify Subjects With Dopaminergic Degeneration Among Subjects Presenting to a Movement Disorders Specialty Clinic With an Uncertain DiagnosisParkinson's Disease;Primary Parkinsonism;Lewy Body Parkinson's DiseaseDrug: 18F-AV-133Avid RadiopharmaceuticalsNULLCompleted40 YearsN/AAll170Phase 2;Phase 3United States;Australia
473NCT01491529
(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
474EUCTR2011-002074-23-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
475EUCTR2011-004378-27-HU
(EUCTR)
28/03/201215/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Product Name: AFQ056
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65United States;France;Hungary;Canada;Spain;Austria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
476EUCTR2011-002074-23-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
477EUCTR2011-004378-27-IT
(EUCTR)
27/03/201202/03/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson's patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: mavoglurant
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
65United States;Hungary;Canada;Spain;Austria;Germany;Italy
478EUCTR2011-002074-23-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
479EUCTR2011-002074-23-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
480EUCTR2011-002074-23-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
481NCT01491932
(ClinicalTrials.gov)
March 20121/12/2011Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll129Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
482NCT01519882
(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
483NCT03061513
(ClinicalTrials.gov)
February 28, 201213/2/2017Ubiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial BiomarkersUbiquinol in Parkinson's Disease: Safety, Tolerability, and Effects Upon Oxidative Damage and Mitochondrial BiomarkersParkinson DiseaseDrug: Ubiquinol;Dietary Supplement: PlaceboWeill Medical College of Cornell UniversityNULLCompleted40 Years75 YearsAll11Phase 2NULL
484EUCTR2011-005054-59-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
485NCT01673724
(ClinicalTrials.gov)
February 201223/8/2012Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's DiseaseEffect of Pramipexole and Bromocriptine on Nonmotor Symptoms of Early Parkinson's Disease: Multicenter, Open-label, Parallel, Randomized StudyParkinson's DiseaseDrug: pramipexole;Drug: BromocriptineSandozNULLCompleted30 YearsN/AAll121Phase 4Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
486NCT01525641
(ClinicalTrials.gov)
February 20121/2/2012Safety and Efficacy of Long-term Daily Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseSpecial Survey on Long-term Drug Use of Mirapex®-LA Tablets in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Mirapex LABoehringer IngelheimNULLCompletedN/AN/AAll615N/AJapan
487NCT01568099
(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
488EUCTR2011-002073-30-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
489NCT01736891
(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
490NCT01457807
(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
491NCT01385592
(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
492EUCTR2011-000056-42-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
493JPRN-UMIN000006521
2011/10/0111/10/2011Switch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's diseaseSwitch trial from Pramipexole IR (Bi-sifrol) to Pramipexole ER (Mirapex LA) in patients with Parkinson's disease - Switch trial from IR to ER of Pramipexole Parkinson's diseaseRapid switch of Pramipexole ER (once in a day) which is same dose as IR. The period of administration is 8 weeks.Department of Neurology, Juntendo UniversityNULLRecruiting20years-oldNot applicableMale and Female30Not selectedJapan
494NCT01479127
(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
495EUCTR2010-018534-44-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
496NCT01474421
(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
497EUCTR2010-018534-44-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
498EUCTR2010-021860-13-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
499EUCTR2010-021394-37-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
500NCT01411137
(ClinicalTrials.gov)
August 20114/8/2011Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety StudyAn Open Label Conversion Study of Carbidopa-Levodopa (CD-LD) Extended-Release Taken Alone or in Combination With CD-LD Immediate Release to IPX066 Followed by an Open-Label Extension Safety Study of IPX066 in Advanced PDParkinson's DiseaseDrug: IPX066Impax Laboratories, LLCMichael J. Fox Foundation for Parkinson's ResearchCompleted30 YearsN/AAll43Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
501NCT01634568
(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
502NCT01370811
(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
503EUCTR2010-021860-13-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
504NCT01397422
(ClinicalTrials.gov)
July 201118/7/2011Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Dyskinesia;Levodopa Induced Dyskinesia;Parkinson's DiseaseDrug: ADS-5102 (extended release amantadine HCl)Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll83Phase 2;Phase 3United States
505EUCTR2010-020112-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
506EUCTR2011-001092-39-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
507EUCTR2010-021860-13-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
508EUCTR2010-022200-46-LV
(EUCTR)
21/06/201101/04/2011Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®) in patients with Pakinson's disease.Efficacy and safety of ODM-101 compared to a standard combination(Stalevo®); a randomised, double-blind, crossover, proof of conceptstudy in patients with Parkinson's disease and end-of-dose motorfluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
509EUCTR2010-020112-11-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
510EUCTR2009-015161-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
511EUCTR2009-013552-72-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
512EUCTR2010-022517-25-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
513EUCTR2008-005492-94-BG
(EUCTR)
25/05/201123/03/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
514EUCTR2010-021394-37-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
515EUCTR2010-022200-46-FI
(EUCTR)
13/05/201123/03/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Germany;Latvia;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
516EUCTR2010-022200-46-LT
(EUCTR)
09/05/201105/04/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Parkinson’s disease.Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Germany;Latvia
517EUCTR2007-002964-90-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
518EUCTR2010-021394-37-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
519NCT01361009
(ClinicalTrials.gov)
May 201123/5/2011a PMS on Safety Profile of Pramipexole in Chinese Parkinson Disease PatientsSafety of Pramipexole Monotherapy or Combination Therapy in Chinese Patients With Parkinson¿s Disease: a 12 Week Post Marketing SurveillanceParkinson DiseaseDrug: pramipexoleBoehringer IngelheimNULLCompleted30 Years75 YearsAll2017N/AChina
520NCT01766258
(ClinicalTrials.gov)
May 201122/11/2012Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor FluctuationsEfficacy and Safety of ODM-101 Compared to a Standard Combination (Stalevo®); a Randomised, Double-blind, Crossover, Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Motor FluctuationsParkinson's DiseaseDrug: ODM-101 65mg Carbidopa;Drug: ODM-101 105mg Carbidopa;Drug: StalevoOrion Corporation, Orion PharmaNULLCompleted30 YearsN/ABoth117Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
521NCT01856439
(ClinicalTrials.gov)
May 201114/5/2013Long Term Safety and Efficacy Study of ProSavin in Parkinson's DiseaseA Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.Parkinson's DiseaseDrug: ProSavinAxovant Sciences Ltd.Oxford BioMedicaActive, not recruitingN/AN/AAll15Phase 1;Phase 2France;United Kingdom
522EUCTR2010-022366-27-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
523EUCTR2010-022366-27-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
524EUCTR2010-022517-25-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
525EUCTR2008-005492-94-PT
(EUCTR)
14/04/201119/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
526EUCTR2009-015161-31-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
527NCT01313819
(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
528NCT01336088
(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
529EUCTR2009-013552-72-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
530EUCTR2010-022366-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
531EUCTR2008-005492-94-CZ
(EUCTR)
14/03/201103/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285Portugal;United States;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Italy;Switzerland;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand
532EUCTR2010-018534-44-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
533EUCTR2010-021860-13-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
534EUCTR2010-021394-37-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
535EUCTR2010-021394-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
536EUCTR2009-015161-31-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
537EUCTR2009-013552-72-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
538EUCTR2008-005492-94-FI
(EUCTR)
04/03/201113/01/2011Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
539EUCTR2010-021394-37-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
540NCT01264861
(ClinicalTrials.gov)
March 201120/12/2010A Study to Evaluate Safinamide's Effect on Dopamine and Serotonin's Availability by Using Brain ImagingOpen-Label Escalating Dose Study Using [123|]ß-CIT SPECT Single Photon Emission Computerized Tomography (SPECT) to Evaluate Dopamine and Serotonin Transporter Occupancy by Safinamide in Parkinson Disease PatientsParkinson DiseaseDrug: SafinamideNewronNULLTerminated40 Years80 YearsAll5Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
541NCT01568073
(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
542NCT01227655
(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
543NCT01283594
(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
544NCT01294800
(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
545EUCTR2010-021860-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
546EUCTR2009-015161-31-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
547EUCTR2010-021394-37-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
548EUCTR2010-021394-37-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
549EUCTR2009-017174-20-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
550EUCTR2009-015161-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
551EUCTR2010-021860-13-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
552EUCTR2010-021860-13-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
553EUCTR2010-021394-37-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
554EUCTR2010-021860-13-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
555EUCTR2009-015161-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
556EUCTR2009-013552-72-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
557NCT01229332
(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
558EUCTR2010-021860-13-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
559EUCTR2010-021860-13-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
560EUCTR2008-004146-88-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
561EUCTR2010-022366-27-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
562EUCTR2009-015161-31-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
563EUCTR2009-013552-72-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
564EUCTR2009-015161-31-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
565EUCTR2009-013552-72-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
566EUCTR2009-015161-31-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
567NCT01244269
(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
568EUCTR2010-021860-13-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
569EUCTR2010-020109-34-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
570EUCTR2010-020109-34-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
571NCT01227265
(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
572EUCTR2010-021860-13-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
573EUCTR2007-001109-26-GB
(EUCTR)
04/11/201005/08/2010A phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s diseaseA phase I/II study of the safety, efficacy and dose evaluation of ProSavin®, administered using stereotactic injection to the striatum of patients with bilateral, idiopathic Parkinson’s disease Patients with bilateral, idiopathic Parkinson's DiseaseOxford BioMedica (UK) LtdNULLNot Recruiting Female: yes
Male: yes
27Phase 1;Phase 2United Kingdom
574EUCTR2009-015161-31-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
575NCT01060878
(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
576EUCTR2010-018534-44-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
577EUCTR2009-013552-72-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
578EUCTR2009-015161-31-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
579EUCTR2007-002964-90-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
580EUCTR2010-019418-25-DE
(EUCTR)
01/10/201019/07/2010Open label, safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 16.0;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ065
Product Name: AFQ056
Product Code: AFQ065
Novartis Pharma Sevices AGNULLNot RecruitingFemale: yes
Male: yes
244France;Canada;Finland;Australia;Germany;Italy;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
581NCT01173731
(ClinicalTrials.gov)
October 201028/7/2010Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasParkinson Disease;Dyskinesia, Drug-Induced;LevodopaDrug: AFQ056Novartis PharmaceuticalsNULLCompletedN/AN/AAll66Phase 2United States;Australia;Canada;France;Germany;Italy;Finland;Spain
582EUCTR2010-019418-25-FR
(EUCTR)
29/09/201015/07/2010An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
244France;Finland;Germany;Italy
583EUCTR2009-017238-39-DE
(EUCTR)
16/09/201028/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Germany;France;Italy
584EUCTR2010-019418-25-FI
(EUCTR)
08/09/201021/07/2010An open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias Moderate to severe levodopa induced dyskinesia in patients with Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013916;Term: Dyskinesia
Product Name: AFQ056
Product Code: AFQ065
Product Name: AFQ056
Product Code: AFQ065
Product Name: AFQ056
Product Code: AFQ065
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
244France;Finland;Germany;Italy
585EUCTR2009-013552-72-FI
(EUCTR)
07/09/201002/07/2010A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (Study P05664)A Phase 3, Double-Blind, Double-Dummy, Placebo- and Active-Controlled Dose-Range-Finding Efficacy and Safety Study of Preladenant in Subjects With Early Parkinson’s Disease (Phase 3 Protocol No. P05664) - PARADYSE - Monotherapy Parkinson's disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Schering-Plough Research Institute, a division of Schering CorporationNULLNot Recruiting Female: yes
Male: yes
1000Phase 3United States;Portugal;Spain;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Netherlands;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
586NCT01162226
(ClinicalTrials.gov)
September 201024/6/2010Computer-Based Balance Training for People With Parkinson's DiseasePD Wii: Computer-based Gait and Balance Training for Parkinson's Patients.Parkinson's DiseaseBehavioral: gait and balance training programUniversity of California, San FranciscoNational Institute of Neurological Disorders and Stroke (NINDS)CompletedN/AN/ABoth62Phase 2United States
587NCT01211587
(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
588EUCTR2009-017253-35-GB
(EUCTR)
20/08/201006/08/2010Long-term study of patients who received ProSavin in the PS1/001/07 clinical trial.A multicentre, open-label extension study to determine the long term safety, tolerability and efficacy of ProSavin® in patients with bilateral, idiopathic Parkinson’s disease Patients with bilateral, idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: ProSavin
INN or Proposed INN: ProSavin
Oxford BioMedica (UK) LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
27United Kingdom
589EUCTR2009-015161-31-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
590NCT01191944
(ClinicalTrials.gov)
August 201030/8/2010Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) PatientsA Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With LevodopaParkinson DiseaseDrug: pramipexole immediate release tablet;Drug: pramipexole extended release tabletBoehringer IngelheimNULLCompleted30 YearsN/AAll475Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
591NCT01785628
(ClinicalTrials.gov)
August 201024/6/2011The Impact of Pharmacological and Electric Modulation of NMDA Pathway on the Cognitive Flexibility and Volitional Movement Preparation in Patients With Parkinson's DiseaseParkinson's Disease With DementiaDietary Supplement: Sarcosine Capsule;Dietary Supplement: Placebo CapsuleChina Medical University HospitalNational Science Council, TaiwanCompletedN/AN/AAll30N/ATaiwan
592EUCTR2009-017182-38-ES
(EUCTR)
26/07/201025/05/2010Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease.Estudio abierto de extensión para evaluar la seguridad y la eficacia de IPX066 en la enfermedad de Parkinson.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson?s Disease. Enfermedad de Parkinson idiopática (parálisis agitante)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals DivisionNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
593NCT01155466
(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
594EUCTR2009-017182-38-LT
(EUCTR)
10/07/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
595EUCTR2009-017182-38-DE
(EUCTR)
09/07/201007/05/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. Idiopathic Parkinson’s disease (paralysis agitans).
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceuticals DivisionNULLNot RecruitingFemale: yes
Male: yes
500Estonia;Spain;Poland;Lithuania;Latvia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
596EUCTR2009-017182-38-PL
(EUCTR)
07/07/201020/05/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease.An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson’s Disease. Idiopathic Parkinson’s disease (paralysis agitans).
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
597NCT01155479
(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
598NCT01171313
(ClinicalTrials.gov)
July 201026/7/2010A Efficacy, Safety and Pharmacokinetic Study of XP21279 and Sinemet® in Parkinson's Disease SubjectsA Phase 2 Efficacy, Safety and Pharmacokinetic Study of XP21279 BL2 and Sinemet® in Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: XP21279 and carbidopa (experimental);Drug: Sinemet (comparator);Drug: Placebo for XP21279 and carbidopa;Drug: Placebo for SinemetXenoPort, Inc.NULLCompleted30 Years80 YearsBoth35Phase 2United States
599NCT01174004
(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
600NCT01149811
(ClinicalTrials.gov)
July 201010/6/2010A Study Comparing the Safety and Tolerability of Two Doses of Fipamezole in Adult Patients With Parkinson's DiseaseA Randomized, Double-Blind, Crossover Study Comparing the Safety and Tolerability of Two Dose Regimens of Oromucosal Fipamezole ODT in Adult Patients With Parkinson's Disease Who Are Receiving LevodopaParkinson's DiseaseDrug: Fipamezole ODT;Drug: Fipamezole ODT Cohort 2Valeant Pharmaceuticals International, Inc.NULLCompleted30 Years75 YearsBoth27United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
601NCT01174810
(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
602EUCTR2009-017182-38-LV
(EUCTR)
11/06/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
603EUCTR2009-013886-24-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
604NCT01140841
(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
605EUCTR2010-018904-94-IT
(EUCTR)
31/05/201014/03/2012EFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASEEFFICACY AND SAFETY OF INTRAMUSCULAR NERIDRONATE IN OSTEOPOROTIC PATIENTS AFFECTED BY PARKINSON'S DISEASE Osteoporosis in patients affected by Parkinson's disaease at the stages 1-2-3-4 following Hoehn and Yahr criteria
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: NERIXIA*IM EV 1F 25MG
INN or Proposed INN: Bisphosphonates
Other descriptive name: Neridronic acid
FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
606EUCTR2009-017182-38-EE
(EUCTR)
14/05/201026/04/2010An Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s DiseaseAn Open-Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects with Parkinson´s Disease Idiopathic Parkinson´s disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Impax Laboratories, Inc. acting through its Impax Pharmaceutical Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
500Germany;Estonia;Spain;Latvia;Poland;Lithuania
607NCT01130493
(ClinicalTrials.gov)
May 201024/5/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) Followed by an Open-Label Safety Study of IPX066 in Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: CLEImpax Laboratories, LLCNULLCompleted30 YearsN/AAll110Phase 3United States;France;Germany;Italy
608EUCTR2009-018137-37-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
609NCT01113320
(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
610NCT01103011
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
611NCT00988117
(ClinicalTrials.gov)
April 201029/9/2009The Effects of the Rivastigmine Patch on Parkinson's Disease With Memory and/or Thinking ProblemsThe Effects of the Rivastigmine Patch on Attention and Behavior in Parkinson's Disease With Dementia (PDD)Parkinsons Disease With Dementia;Parkinsons Disease With Mild to Moderate Memory and/or Thinking ProblemsDrug: Rivastigmine Patch 9.5 cm2University of California, San FranciscoNovartisCompleted55 YearsN/AAll15Phase 4United States
612EUCTR2009-017174-20-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
613EUCTR2009-013886-24-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
614NCT01066442
(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
615NCT01092065
(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
616NCT01096186
(ClinicalTrials.gov)
March 201025/3/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseAn Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX066 95 mg;Drug: IPX066 145 mg;Drug: IPX066 195 mg;Drug: IPX066 245 mgImpax Laboratories, LLCNULLCompleted30 YearsN/AAll617Phase 3United States;Canada;Estonia;Germany;Latvia;Lithuania;Poland;Romania;Spain;Ukraine
617EUCTR2009-017174-20-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
618EUCTR2007-002963-28-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
619EUCTR2009-014688-37-PL
(EUCTR)
09/02/201020/01/2010A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/AA Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson’s Disease - N/A Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 13.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
620EUCTR2008-005492-94-BE
(EUCTR)
25/01/201012/08/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
621EUCTR2008-005492-94-NL
(EUCTR)
18/01/201025/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - Idiopathic Parkinson's Disease
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1285Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
622NCT01063621
(ClinicalTrials.gov)
January 20104/2/2010Extended Long-Term Safety Study of KW-6500Phase 3 Study of KW-6500 (Safety Study for Extended Long-Term Self-Injection at Home in Patients With Parkinson's Disease)Parkinson's DiseaseDrug: KW-6500Kyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll27Phase 3Japan
623EUCTR2009-014688-37-ES
(EUCTR)
30/12/200921/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada.A Study To Evaluate The Safety And Efficacy Of IPX066 in Advanced Parkinsons DiseaseEstudio para evaluar la seguridad y eficacia de IPX066 en la enfermedad de Parkinson avanzada. Advanced Parkinsons Disease subjects with motor fluctuationsEnfermedad de Parkinson avanzada en sujetos con fluctuaciones motoras
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Sinemet-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
624EUCTR2009-014688-37-DE
(EUCTR)
15/12/200907/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLNot RecruitingFemale: yes
Male: yes
350Germany;France;Spain;Poland
625EUCTR2008-005492-94-GB
(EUCTR)
09/12/200901/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
626EUCTR2009-012897-12-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
627EUCTR2009-014688-37-FR
(EUCTR)
04/12/200909/10/2009A Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s DiseaseA Study To Evaluate The Safety And Efficacy Of IPX066In Advanced Parkinson’s Disease Advanced Parkinson’s Disease subjects with motor fluctuations
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: SINEMET®-Plus Tablets
Product Name: IR CD-LD
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
350Germany;France;Spain;Poland
628NCT00660387
(ClinicalTrials.gov)
December 200915/4/2008Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll35Phase 3United States;New Zealand
629NCT01036139
(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
630NCT01049984
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
631EUCTR2009-013886-24-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
632EUCTR2008-005492-94-FR
(EUCTR)
25/11/200901/10/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients - Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1285Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
633EUCTR2008-005492-94-ES
(EUCTR)
23/11/200918/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients.Estudio abierto para determinar la seguridad a largo plazo de la Safinamida en pacientes con enfermedad de Parkinson - Idiopathic Parkinson's DiseaseEnfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1285Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
634EUCTR2009-013885-14-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
635EUCTR2009-013885-14-ES
(EUCTR)
12/11/200923/09/2009A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas.A randomized, multicenter 12-Week double-blind placebo-controlled study to assess the efficacy and safety of BF2.649 in Excessive Daytime Sleepiness in Parkinson?s disease followed by a 38-Week open-label extension phase.Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de 12 semanas de duración para evaluar la eficacia y seguridad de BF2.649 en la somnolencia diurna excesiva de la enfermedad de Parkinson, seguido de una fase de extensión abierta de 38 semanas. Excessive daytime sleepiness in Parkinson?s DiseaseSomnolencia diurna excesiva en la enfermedad de Parkinson.
MedDRA version: 12.0;Level: LLT;Classification code 10015595;Term: Excessive daytime sleepiness
MedDRA version: 12.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism
Product Name: Pitolisant
Product Code: BF2.649
INN or Proposed INN: Pitolisant
BIOPROJETNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
246France;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
636NCT01023282
(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
637NCT00985517
(ClinicalTrials.gov)
October 29, 200925/9/2009Safety and Efficacy of CERE-120 in Subjects With Parkinson's DiseaseA Phase 1/2 Trial Assessing the Safety and Efficacy of Bilateral Intraputaminal and Intranigral Administration of CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]) in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseBiological: CERE-120: Adeno-Associated Virus Delivery of Neurturin;Procedure: Sham SurgerySangamo TherapeuticsNULLCompleted35 Years70 YearsAll57Phase 1;Phase 2United States
638EUCTR2008-005492-94-HU
(EUCTR)
27/10/200922/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Portugal;Estonia;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
639EUCTR2008-004146-88-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
640EUCTR2008-005492-94-SK
(EUCTR)
14/10/200922/10/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1285Phase 3Portugal;Estonia;Slovakia;Finland;Spain;Austria;Italy;United Kingdom;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
641EUCTR2008-005492-94-AT
(EUCTR)
02/10/200903/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 15.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
642EUCTR2008-005492-94-EE
(EUCTR)
01/10/200915/09/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Thailand;Spain;Chile;Colombia;Switzerland;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
643NCT00957203
(ClinicalTrials.gov)
October 20097/8/2009Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease PatientsLong-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)Parkinson's DiseaseDrug: IstradefyllineKyowa Hakko Kirin Company, LimitedNULLCompleted20 YearsN/ABoth308Phase 3Japan
644NCT00943748
(ClinicalTrials.gov)
October 200920/7/2009Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's DiseaseEfficacy and Safety of the Iron Chelator Deferiprone on Iron Overload in the Brain in Parkinson's DiseaseParkinson's DiseaseDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted30 Years80 YearsBoth40Phase 2;Phase 3France
645NCT01028586
(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
646NCT00957918
(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
647EUCTR2006-005186-18-NL
(EUCTR)
25/09/200929/05/2008Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
648NCT00903838
(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
649NCT00974974
(ClinicalTrials.gov)
September 200910/9/2009A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's DiseaseParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll471Phase 3United States;Canada;France;Germany;Poland;Romania;Spain;Ukraine
650NCT00986414
(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
651NCT01026428
(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
652EUCTR2008-004146-88-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
653EUCTR2008-008712-98-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
654NCT01580787
(ClinicalTrials.gov)
August 200916/4/2012Functional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual EnvironmentFunctional Improvement in Patients With Parkinson's Disease After Training in Real or Virtual EnvironmentParkinson´s DiseaseDevice: Balance Training with Nintendo Wii Fit;Other: Physical TherapySao Camilo University CenterNULLCompleted65 Years85 YearsBoth32N/ANULL
655EUCTR2008-004146-88-PT
(EUCTR)
31/07/200914/04/2009A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918A phase III, double-blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of low (50 mg/day) and high (100 mg/day) dose safinamide, as add-on therapy in subjects with early idiopathic Parkinson?s disease treated with a stable dose of a single dopamine agonist - Safinamide in early PD patients treated with a single dopamine agonist. Extension Trial to 27918 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: Safinamide
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
498Phase 3Portugal;Czech Republic;Finland;Poland;Spain;Bulgaria;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
656NCT00955318
(ClinicalTrials.gov)
July 20097/8/2009Long-Term Safety Study of KW-6500 in Patients With Parkinson's DiseasePhase 3 Study of KW-6500 (Safety Study for Long-Term Self-Administration at Home in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: KW-6500Kyowa Hakko Kirin Co., LtdNULLCompleted20 YearsN/AAll58Phase 3Japan
657NCT00909545
(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
658NCT00918177
(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
659EUCTR2008-004146-88-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
660EUCTR2008-001966-10-EE
(EUCTR)
16/06/200913/05/2009A phase III, double blind, placebo-controlled extension trial to investigate the long-term efficacy and safety of safinamide (50 to 100 mg/day), as add on therapy, in subjects with idiopathic Parkinson’s disease with motor fluctuations, treated with a stable dose of levodopa and who may be receiving concomitant treatment with stable doses of a dopamine agonist, an anticholinergic and/or amantadine - Safinamide in PD with motor fluctuations, as add-on to levodopa. Extension to trial 27919 Idiopathic Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Safinamide
Product Code: NW-1015
Product Name: Safinamide
Product Code: NW-1015
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
416Phase 3Hungary;United Kingdom;Estonia;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
661EUCTR2008-008712-98-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
662EUCTR2008-004146-88-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
663EUCTR2009-010193-38-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
664EUCTR2009-010193-38-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
665NCT00833690
(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
666NCT00360568
(ClinicalTrials.gov)
June 20093/8/2006Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's SubjectsOpen-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsDyskinesias;Parkinson's Disease;Severe Motor FluctuationsDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll62Phase 3United States;Germany;New Zealand
667NCT01519856
(ClinicalTrials.gov)
June 200912/3/2010PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term TherapyEfficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive FunctionParkinson's DiseaseDrug: piribedil (Clarium)Desitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth908N/AGermany
668EUCTR2008-001966-10-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
669EUCTR2008-004146-88-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
670EUCTR2008-004146-88-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
671EUCTR2008-001966-10-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
672EUCTR2008-004146-88-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
673EUCTR2008-008712-98-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
674EUCTR2008-008712-98-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
675EUCTR2008-001966-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
676EUCTR2008-000400-81-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
677EUCTR2006-000578-53-DE
(EUCTR)
08/05/200930/10/2008Open-Label, 12-Month Safety and Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease SubjectsOpen-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
Product Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott LaboratoriesNULLNot RecruitingFemale: yes
Male: yes
70United States;Germany;New Zealand
678EUCTR2009-010193-38-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
679EUCTR2008-001966-10-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
680EUCTR2007-002963-28-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
681NCT00914602
(ClinicalTrials.gov)
May 20093/6/2009An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease SubjectsAn Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: XP21279;Drug: Sinemet®;Drug: Lodosyn®XenoPort, Inc.NULLCompleted30 Years75 YearsBoth14Phase 1;Phase 2United States
682EUCTR2008-002769-30-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
683EUCTR2008-005492-94-IT
(EUCTR)
30/04/200915/04/2009OPEN LABEL TRIAL TO DETERMINE THE LONG TERM SAFETY OF SAFINAMIDE IN PARKINSON`S DISEASE PATIENTS - ND IDIOPATHIC PARKINSON`S DISEASE
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: SAFINAMIDE
Product Code: NW-1015
Product Name: SAFINAMIDE
Product Code: NW-1015
MERCK SERONO SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
700Hungary;Portugal;Germany;Netherlands;France;Bulgaria;Italy;Austria;United Kingdom;Czech Republic;Belgium;Estonia;Spain
684EUCTR2007-004234-16-AT
(EUCTR)
14/04/200910/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
685EUCTR2007-001095-36-SK
(EUCTR)
09/04/200909/04/2008The Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh StudyThe Van Gogh Study: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo and Pramipexole Controlled Study to Assess Efficacy and Safety of SLV308 as Adjunct Therapy to L-dopa in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - The Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
625Phase 3Hungary;Slovakia
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
686EUCTR2008-000400-81-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
687EUCTR2007-002964-90-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
688EUCTR2007-002963-28-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
689EUCTR2007-004235-37-AT
(EUCTR)
02/04/200910/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
690NCT00880620
(ClinicalTrials.gov)
April 20093/4/2009A Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's DiseaseA Placebo-Controlled Study To Evaluate The Safety And Efficacy Of IPX066 In Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: Placebo;Drug: IPX066 95 mg LD;Drug: IPX066 145 mg LD;Drug: IPX066 195 mg LD;Drug: IPX066 245 mg LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll381Phase 3United States;Canada;Estonia;Latvia;Lithuania;Romania;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
691NCT00865579
(ClinicalTrials.gov)
April 200910/3/2009Open-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label Trial to Determine the Long-Term Safety of Safinamide in Parkinson's Disease PatientsParkinson's DiseaseDrug: SafinamideNewronNULLTerminated30 YearsN/AAll964Phase 3Romania
692NCT00875316
(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
693EUCTR2008-000400-81-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
694EUCTR2007-003035-22-AT
(EUCTR)
30/03/200926/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
560Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
695EUCTR2008-004447-11-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
696EUCTR2007-002963-28-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
697EUCTR2007-002964-90-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
698NCT00866502
(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
699NCT00888004
(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
700EUCTR2006-005186-18-CZ
(EUCTR)
09/02/200921/11/2007Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
Product Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320United States;Portugal;Finland;Thailand;Spain;Israel;Russian Federation;United Kingdom;Italy;Czech Republic;Canada;Poland;Australia;Germany;Netherlands;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
701NCT00627640
(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
702NCT01421719
(ClinicalTrials.gov)
February 200919/8/2011Safety and Efficacy of botulinumA Toxin (BotoxA) for Treatment of Neurogenic Bladder of Parkinson's DiseaseOnabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and EfficacyParkinson's Disease;Neurogenic Bladder;Urinary Incontinence;Clostridium Botulinum Toxin Adverse ReactionDrug: Cystoscopic injection of Botox into the urinary bladderStanford UniversityAllerganCompleted50 Years85 YearsAll20Phase 4United States
703EUCTR2007-007853-30-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
704EUCTR2007-002963-28-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
705EUCTR2007-003035-22-PT
(EUCTR)
09/01/200901/07/2008A safety and tolerability study of ACP-103 in patients with Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease
MedDRA version: 18.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ACADIA Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
400Phase 3Portugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
706EUCTR2007-003035-22-IT
(EUCTR)
07/01/200923/07/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease - ACP-103-015 Psychosis in Parkinson?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: primavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: primavanserin tartrate
ACADIA PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
486Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden
707NCT00357994
(ClinicalTrials.gov)
January 200927/7/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll36Phase 3United States;Germany
708EUCTR2004-000148-26-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
709NCT00809302
(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
710EUCTR2008-004943-12-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
711EUCTR2006-005186-18-GB
(EUCTR)
19/11/200827/06/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Abbott Healthcare Products B.V.NULLNot Recruiting Female: yes
Male: yes
320Phase 3Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
712EUCTR2007-006721-27-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
713EUCTR2007-003051-36-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
714EUCTR2007-003035-22-GB
(EUCTR)
05/11/200820/12/2007 A safety and tolerability study of ACP-103 in patients with Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease - ACP-103-015 Psychosis in Parkinson's Disease
MedDRA version: 20.0;Level: LLT;Classification code 10037241;Term: Psychosis NOS;System Organ Class: 100000004873 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ACADIA Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
400Phase 3United States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
715EUCTR2007-006721-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
716EUCTR2007-004235-37-IT
(EUCTR)
02/10/200828/11/2007Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - NDLong-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND Patients with advanced idiopathic PD
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2Y
INN or Proposed INN: Pramipexole
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
717EUCTR2006-005186-18-DE
(EUCTR)
30/09/200813/11/2008Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson’s DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
Product Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
718EUCTR2008-003225-16-FI
(EUCTR)
10/09/200830/05/2008Aivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilaillaAivostimulaattorin ja levodopainfuusion vaikutus elämänlaatuun ja autonomisen hermoston toimintaan Parkinsonin tautia sairastavilla potilailla Vaikeahoitoinen Parkinsonin tauti potilailla, joille on aiemmin asetettu aivostimulaattori, tai on päädytty päivittäisten oireiden vuoksi aloittamaan Duodopa-infuusio.
MedDRA version: 9.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS
Trade Name: DuodopaOrganisation name was not enteredNULLNot RecruitingFemale: yes
Male: yes
Finland
719EUCTR2007-003051-36-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
720EUCTR2007-003051-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
721EUCTR2007-003035-22-BE
(EUCTR)
02/09/200821/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: pimavanserin (ACP-103)
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
722NCT00755027
(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
723NCT00758849
(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
724EUCTR2007-004235-37-GB
(EUCTR)
19/08/200826/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
725NCT00656253
(ClinicalTrials.gov)
August 20087/4/2008Clinical Trial on the Effectiveness of Herbal Medicinal Mixture in Parkinson DiseaseParkinson's DiseaseDrug: Herbal Medicinal Mixture (Roucongrong, Heshouwu etc.);Drug: PlaceboFudan UniversityChina's Ministry of Health; Administration of Traditional Chinese Medicine (SATCM)Completed50 YearsN/ABoth158Phase 2;Phase 3China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
726NCT01010802
(ClinicalTrials.gov)
August 20088/11/2009Safety Study of Erythropoietin (EPO) in Parkinson's DiseasePhase 1 Study of Recombinant Human Erythropoietin (rhEPO) in Parkinson's Disease (PD)Parkinson DiseaseDrug: Erythropoietin human recombinant (EPOrh)International Center for Neurological Restoration, CubaCentro de Immunologia Molecular, CubaCompleted45 Years75 YearsAll10Phase 1Cuba
727EUCTR2004-000148-26-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
728EUCTR2007-003051-36-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
729EUCTR2007-003051-36-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
730EUCTR2007-002963-28-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
731EUCTR2007-003035-22-SE
(EUCTR)
11/06/200816/05/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: Pimavanserin tartrate
Product Code: pimavanserin (ACP-103)
INN or Proposed INN: Pimavanserin tartrate
Acadia Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
400Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
732EUCTR2007-002964-90-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
733NCT00822913
(ClinicalTrials.gov)
June 200814/1/2009Botulinum A Toxin in Patients With Parkinson's DiseaseThe Use of Toxin Botulinum A Toxin in Patients With Parkinson's Disease and Multiple System Disease, Affected by Refractory Detrusor Overactivity.Parkinson's Disease;Multiple System Atrophy;Detrusor OveractivityDrug: Intravesical injection of Botulinum A toxinUniversity Of PerugiaUniversity of Roma La SapienzaEnrolling by invitation18 Years80 YearsBoth20Phase 4NULL
734EUCTR2007-004235-37-PL
(EUCTR)
29/05/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden
735EUCTR2007-004235-37-SE
(EUCTR)
23/04/200825/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
736EUCTR2007-004234-16-FI
(EUCTR)
16/04/200812/02/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
520Hungary;Finland;Czech Republic;Netherlands;France;Austria
737EUCTR2007-002906-23-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
738EUCTR2007-001096-10-SK
(EUCTR)
11/04/200809/04/2008An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh StudyAn Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Slovakia
739NCT00753636
(ClinicalTrials.gov)
April 200813/9/2008Parkinson's Disease Isradipine Safety StudyPhase II Safety and Tolerability of Isradipine (A Potential Neuroprotective Agent) in Patients With Parkinson's Disease- Stage IIParkinson's DiseaseDrug: Dynacirc CR (Isradipine)Northwestern UniversityNorthwestern Memorial HospitalCompleted30 Years75 YearsAll31Phase 2United States
740EUCTR2007-005033-11-DE
(EUCTR)
27/03/200804/01/2008A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s DiseaseA Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease Patients with Parkinson's DiseaseProduct Name: Levodopa-Carbidopa Multilayer Extended Release Tablet
Product Code: Levodopa-Carbidopa XL tablet (M)
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet® CR
Product Name: Sinemet CR
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
741EUCTR2007-001096-10-HU
(EUCTR)
27/03/200815/02/2008An Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh StudyAn Extension of the Van Gogh Study: An Open Label SLV308 Safety Extension to Study S308.3.004 in Patients with Parkinson’s Disease Experiencing Motor Fluctuations - An Extension of the Van Gogh Study advanced stage of idiopathic PD with dose-dependent motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
INN or Proposed INN: Pardoprunox hydrochloride
Product Name: Pardoprunox
Product Code: SLV308
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
500Hungary
742EUCTR2006-003732-30-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
743EUCTR2007-001095-36-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
744EUCTR2007-002964-90-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
745EUCTR2007-004235-37-HU
(EUCTR)
17/03/200817/01/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
746EUCTR2007-004234-16-HU
(EUCTR)
17/03/200817/01/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
747EUCTR2006-005186-18-PT
(EUCTR)
07/03/200814/11/2007An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications”An Open-Label, 12-Month Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor- Fluctuations Despite Optimized Treatment with Available Parkinson’s Disease Medications” Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Abbott Healthcare Products B.V.NULLNot RecruitingFemale: yes
Male: yes
320Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
748NCT00727727
(ClinicalTrials.gov)
March 200831/7/2008SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)Stabilization on, or Change-Over to the Non-Ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Private Practices.Parkinson's DiseaseDrug: PiribedilDesitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth750N/AGermany
749NCT00658567
(ClinicalTrials.gov)
March 200810/4/2008A Study of Safety and Efficacy of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll123Phase 3United States;Austria;Belgium;Italy;Poland;Portugal;Serbia;Spain;Sweden
750NCT00607451
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
751NCT00761137
(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
752EUCTR2007-003035-22-FR
(EUCTR)
29/02/200815/02/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s DiseaseA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson’s Disease Psychosis in Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Acadia Pharmaceuticals IncNULLNot Recruiting Female: yes
Male: yes
486Phase 2;Phase 3Portugal;France;Belgium;Austria;Italy;United Kingdom;Sweden
753EUCTR2007-002964-90-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
754EUCTR2007-002964-90-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
755EUCTR2006-005186-18-IT
(EUCTR)
08/02/200814/11/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa ? Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations - ND Parkinson Disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Duodopa gel intestinale
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals BV.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
756EUCTR2007-004235-37-ES
(EUCTR)
24/01/200808/03/2010Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
757EUCTR2007-002467-27-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
758EUCTR2006-005186-18-ES
(EUCTR)
23/01/200829/11/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsEstudio abierto de 6-12 meses de duración que evaluará la seguridad y eficacia de un gel intestinal de Levodopa-Carbidopa en pacientes con enfermedad de Parkinson avanzada que responde a Levodopa y fluctuaciones motoras severas - Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.Tratamiento de la enfermedad de Parkinson avanzada que responde a Levidopa con fluctuaciones motoras severas
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Solvay Pharmaceuticals B.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Portugal;Finland;Germany;United Kingdom;Czech Republic;Netherlands;Spain;Italy
759EUCTR2007-004235-37-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden
760EUCTR2007-004234-16-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
761EUCTR2007-002964-90-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
762EUCTR2007-002963-28-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
763EUCTR2007-004235-37-SK
(EUCTR)
14/01/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
764EUCTR2007-004234-16-SK
(EUCTR)
14/01/200818/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 3France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
765EUCTR2007-004234-16-FR
(EUCTR)
11/01/200819/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
BOEHRINGER INGELHEIMNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
766NCT00601523
(ClinicalTrials.gov)
January 200815/1/2008Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Parkinson DiseaseDrug: Placebo;Drug: PramipexoleBoehringer IngelheimNULLCompleted30 YearsN/AAll511Phase 3United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina
767NCT00623103
(ClinicalTrials.gov)
January 200814/2/2008Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)A 76-week Prospective, Open-label, Multicenter Study to Evaluate the Long-term Effect of Rivastigmine Capsule and Transdermal Patch on Worsening of the Underlying Motor Symptoms of PD in Patients With Mild to Moderately Severe Dementia Associated With Parkinson's Disease (PDD)Parkinson's Disease DementiaDrug: Rivastigmine capsule;Drug: Rivastigmine transdermal patchNovartisNULLCompleted50 Years85 YearsAll583Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Turkey;United Kingdom
768NCT00623324
(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
769NCT00627588
(ClinicalTrials.gov)
January 200831/1/2008Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin for the Treatment of Bilateral Idiopathic Parkinson's DiseaseA Phase I/II Study of the Safety, Efficacy and Dose Evaluation of ProSavin®, Administered Using Stereotactic Injection to the Striatum of Patients With Bilateral, Idiopathic Parkinson's Disease.Parkinson's DiseaseBiological: ProSavinOxford BioMedicaNULLCompleted48 Years65 YearsBoth15Phase 1;Phase 2France;United Kingdom
770NCT00725478
(ClinicalTrials.gov)
January 200828/7/2008SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's DiseaseStabilization on, or Change-over to the Non-ergot Dopamine Agonist Piribedil in Patients With Morbus Parkinson - a Post Marketing Surveillance Study in Parkinson Clinic Ambulances and Larger Private Practices.Parkinson's DiseaseDrug: PiribedilDesitin Arzneimittel GmbHNULLCompleted18 YearsN/ABoth250N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
771NCT00335153
(ClinicalTrials.gov)
January 20088/6/2006Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's DiseaseAn Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease MedicationsAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll354Phase 3United States;Australia;Canada;Czech Republic;Finland;Germany;Israel;Italy;Netherlands;New Zealand;Poland;Portugal;Russian Federation;Spain;Thailand;United Kingdom;Greece
772NCT00608231
(ClinicalTrials.gov)
January 20087/1/2008Dexmedetomidine Effects on Microelectrode Recording in Deep Brain StimulationDexmedetomidine Effects on Microelectrode Recording in Deep Brain StimulationParkinson's Disease;Essential Tremor;DystoniaDrug: Dexmedetomidine Hydrochloride Infusion;Drug: Normal SalineVanderbilt UniversityNULLWithdrawn18 YearsN/ABoth0Phase 2;Phase 3United States
773EUCTR2006-003732-30-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
774EUCTR2007-004400-12-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
775EUCTR2007-004654-81-GB
(EUCTR)
20/12/200716/10/2007A phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patientsA phase IIa study to evaluate the relative efficacy and safety/tolerability of a single agent vs. a combination treatment for reducing saliva secretion in Parkinson’s disease patients Sialorrhoea associated with Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10059812;Term: Sialorrhoea
Trade Name: Catapres ampoules
INN or Proposed INN: Clonidine hydrochloride
Trade Name: Ditropan elixir
INN or Proposed INN: Oxybutynin hydrochloride
Summit (Cambridge) Ltd.NULLNot RecruitingFemale: yes
Male: yes
Phase 2aUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
776EUCTR2007-000801-30-HU
(EUCTR)
20/12/200715/11/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
777EUCTR2007-002963-28-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
778EUCTR2007-002964-90-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
779EUCTR2007-002963-28-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
780EUCTR2007-002964-90-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
781EUCTR2007-002964-90-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
782NCT00577460
(ClinicalTrials.gov)
December 200719/12/2007Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PDLong-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)Parkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll391Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
783EUCTR2007-000801-30-ES
(EUCTR)
29/11/200712/09/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motorasA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsEstudio de extensión abierto y multicéntrico para la evaluación a largo plazo de la seguridad, la tolerabilidad y la eficacia de E2007 como tratamiento complementario en pacientes con enfermedad de Parkinson tratados con levodopa que padecen fluctuaciones motoras Parkinson's DiseaseEnfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
784NCT00537017
(ClinicalTrials.gov)
November 23, 200727/9/2007Follow Up Safety Study of SCH 420814 in Subjects With Parkinson's Disease (P05175)A Phase 2, 36-Week, Open-Label, Uncontrolled Safety Follow-up Study Assessing SCH 420814 (Preladenant) 5 mg BID (P05175)Parkinson Disease;Neurodegenerative Diseases;Central Nervous System Diseases;Movement Disorders;Brain DiseasesDrug: Preladenant;Drug: L-dopa;Drug: Other Parkinson's Disease treatmentsMerck Sharp & Dohme Corp.NULLCompleted30 YearsN/AAll140Phase 2Argentina;Australia;Canada;Chile;Colombia;France;Guatemala;Hong Kong;Singapore;Spain;United States
785EUCTR2006-005186-18-FI
(EUCTR)
16/11/200704/10/2007Open-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-FluctuationsOpen-Label, 6-12 Months Safety and Efficacy Study of Levodopa – Carbidopa Intestinal Gel in Levodopa-Responsive Subjects with Advanced Parkinson's Disease and Severe Motor-Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: PhEur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: PhEur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylpropanoic acid
Solvay Pharmaceuticals B.V.NULLNot RecruitingFemale: yes
Male: yes
250Portugal;Czech Republic;Finland;Spain;Germany;Netherlands;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
786EUCTR2007-002906-23-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
787ChiCTR-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
788NCT00558337
(ClinicalTrials.gov)
November 200712/11/2007Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's DiseaseAn Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease PatientsParkinson's DiseaseDrug: levodopa-carbidopaOsmotica Pharmaceutical Corp.NULLCompleted30 Years80 YearsBoth78Phase 2Argentina
789NCT00560508
(ClinicalTrials.gov)
November 200716/11/2007A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment PeriodA Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ERParkinson DiseaseDrug: Pramipexole Immediate Release;Drug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted1 YearN/AAll112Phase 2;Phase 3Japan
790NCT00605683
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
791EUCTR2007-004234-16-NL
(EUCTR)
29/10/200717/10/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
792EUCTR2007-001717-42-FR
(EUCTR)
25/10/200711/09/2007A Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/AA Phase 2, 36 Week, Open-Label, Uncontrolled Safety Follow-Up Study Assessing SCH 420814 5 mg BID - N/A Patients with Moderate to Severe Parkinson's Disease Experiencing Motor Fluctuations and DyskinesiasProduct Name: SCH 420814
Product Code: N/A
Schering Plough Research InstituteNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2France;Spain
793EUCTR2007-002906-23-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
794EUCTR2007-003353-90-NL
(EUCTR)
23/10/200707/08/2007A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Pramipexole
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer IngelheimNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Germany;Netherlands;France
795EUCTR2007-000801-30-FR
(EUCTR)
22/10/200723/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
726Hungary;Czech Republic;Estonia;France;Spain;Italy;Latvia;Poland;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
796EUCTR2007-003353-90-FR
(EUCTR)
17/10/200727/08/2007A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Pramipexole
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
BOEHRINGER INGELHEIMNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
145Germany;Netherlands;France
797EUCTR2005-005791-32-SE
(EUCTR)
04/10/200730/07/2007Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.
MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)
Product Name: HF0220
Product Code: HF0220
Other descriptive name: 7-beta-hydroxyepiandrosterone
Hunter-Fleming LtdNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom;Sweden
798EUCTR2007-002900-16-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
799NCT00582673
(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
800NCT00559871
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
801NCT01520727
(ClinicalTrials.gov)
October 200718/1/2012A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male SubjectsA Single Oral Ascending Dose Study to Investigate the Safety, Pharmacokinetics and Catechol-O-methyltransferase (COMT) Inhibition Profiles of BIA 9-1067 in Healthy Male SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years45 YearsMale64Phase 1France
802NCT00558025
(ClinicalTrials.gov)
October 200712/11/2007Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson DiseaseA Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IRParkinson DiseaseDrug: Pramipexole Extended Release;Drug: Pramipexole Immediate ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll156Phase 3France;Germany;Netherlands
803EUCTR2006-002937-20-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
804EUCTR2007-002899-34-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
805EUCTR2007-002874-75-IT
(EUCTR)
10/09/200714/01/2008Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005Safety and effectivness of Open- Label Melperone in the treatment of Patients with Psycosis Associated with Parkinson's Disease'' - OV-1005 Psycosis associated to Parkinson's Disease
MedDRA version: 9.1;Level: HLT;Classification code 10027361;Term: Mental disorders due to a general medical condition NEC
Product Name: MelperonOVATION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
806EUCTR2007-000801-30-LT
(EUCTR)
07/09/200705/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
807EUCTR2007-003353-90-DE
(EUCTR)
05/09/200708/08/2007A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR.A double-blind, double-dummy, randomized, parallel groups study toassess the Efficacy, Safety and Tolerability of switching patients withearly Parkinson’s disease (PD) from Pramipexole IR to Pramipexole ERor Pramipexole IR. Male or female patients with idiopathic Parkinson's disease diagnosed within 5 years, with a modified Hoehn and Yahr scale of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Trade Name: Sifrol
Product Name: Pramipexole
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
132Germany;Netherlands;France
808EUCTR2007-000801-30-PL
(EUCTR)
29/08/200717/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
809EUCTR2007-000801-30-EE
(EUCTR)
22/08/200717/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
810EUCTR2006-000859-18-DE
(EUCTR)
13/08/200705/04/2007An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Czech Republic;Germany;Netherlands;Estonia;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
811EUCTR2007-000074-23-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
812EUCTR2007-000801-30-CZ
(EUCTR)
01/08/200715/06/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
813NCT00335374
(ClinicalTrials.gov)
August 20078/6/2006An Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD PatientsAn Open Label SLV308 Safety Extension to Study S308.3.003 in Early PD PatientsEarly Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth202Phase 3United States;Australia;Czech Republic;Estonia;Germany;India;Italy;Lithuania;Malaysia;Netherlands;Poland;Portugal;South Africa;Taiwan;Thailand;France;Spain;United Kingdom
814NCT00407095
(ClinicalTrials.gov)
August 200730/11/2006An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.An Open Label SLV308 Safety Extension to Study S308.3.002 in Patients With Parkinson's Disease Experiencing Motor Fluctuations.Advanced Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth140Phase 3United States;Albania;Argentina;Brazil;Bulgaria;Canada;Chile;Colombia;Latvia;Lithuania;Peru;Russian Federation;Ukraine
815NCT00442780
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
816NCT01286935
(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
817EUCTR2007-000801-30-LV
(EUCTR)
27/07/200705/07/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects with Motor Fluctuations Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: E2007
Product Code: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
726Hungary;Czech Republic;France;Estonia;Spain;Italy;Latvia;Poland;Lithuania
818EUCTR2007-000801-30-IT
(EUCTR)
17/07/200713/11/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - NDA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations - ND Parkinson's Disease Subjects with Motor Fluctuations
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: E2007EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
726Phase 3France;Hungary;Estonia;Czech Republic;Spain;Poland;Lithuania;Latvia;Italy
819NCT00550238
(ClinicalTrials.gov)
July 200726/10/2007A Study of the Safety and Tolerability of Pimavanserin (ACP-103) in Patients With Parkinson's Disease PsychosisA Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's DiseaseParkinson's Disease PsychosisDrug: Pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompleted40 YearsN/AAll459Phase 3United States;Austria;Belgium;Canada;France;India;Italy;Poland;Portugal;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom
820NCT00593606
(ClinicalTrials.gov)
July 200721/12/2007Safety and Tolerability Trial of Switching From Ropinirole to RotigotineA Phase 3b, Open-Label, Multicenter Trial to Assess the Safety and Tolerability of Switching Korean Subjects From Ropinirole to the Rotigotine Transdermal System and Its Effect on Symptoms in Idiopathic Parkinson's DiseaseParkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted18 YearsN/AAll124Phase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
821NCT00515437
(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
822NCT00505622
(ClinicalTrials.gov)
July 20079/7/2007Evaluation of the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Perampanel (E2007) as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Subjects With Motor FluctuationsParkinson's DiseaseDrug: PerampanelEisai LimitedNULLTerminated30 YearsN/AAll328Phase 3France
823EUCTR2007-000073-39-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
824EUCTR2007-000074-23-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
825EUCTR2006-000678-57-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
826EUCTR2007-000074-23-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
827EUCTR2007-000073-39-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
828EUCTR2007-000073-39-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
829EUCTR2006-005861-21-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
830EUCTR2006-000858-45-SE
(EUCTR)
05/06/200704/04/2007An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Finland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
831JPRN-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
832NCT00485069
(ClinicalTrials.gov)
June 200711/6/2007REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 StudyPost-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety -Parkinson Disease;Parkinson's DiseaseDrug: ROP;Drug: ROP+L-DopaGlaxoSmithKlineNULLCompleted20 YearsN/AAll123Phase 4Japan
833NCT00477672
(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
834EUCTR2007-000074-23-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
835EUCTR2007-000073-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
836EUCTR2007-000074-23-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
837EUCTR2007-000073-39-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
838EUCTR2007-000074-23-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
839EUCTR2007-000074-23-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
840EUCTR2007-000074-23-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
841NCT00489255
(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
842NCT00479401
(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
843EUCTR2006-000577-29-DE
(EUCTR)
27/04/200712/10/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson’s Subjects Receiving Optimized Treatments with Parkinson Medicinal Products who Continue toExperience Persistent Motor Fluctuations Treatment of levodopa-responsive Parkinson's subjects with severe motor fluctuations.
MedDRA version: 14.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: DUODOPA®Intestinal Gel
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Trade Name: Sinemet®25-100
INN or Proposed INN: Levodopa
Other descriptive name: 3-(3,4-Dihydroxyphenyl)-L-alanine; L-3-(3,4-Dihydroxyphenyl)alanine; L-DOPA
INN or Proposed INN: Carbidopa Monohydrate
Other descriptive name: (minus)-L-alpha-hydrazino-3,4-dihydroxy-alpha-methylbenzenepropanoic acid monohydrate
Abbott Products, Inc (Abbott Products Inc. is part of the parent company, Abbott Laboratories)NULLNot RecruitingFemale: yes
Male: yes
31United States;Germany
844EUCTR2006-002339-26-PT
(EUCTR)
27/04/200707/03/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Hungary;Portugal;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
845EUCTR2007-000073-39-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
846EUCTR2007-000307-15-IT
(EUCTR)
24/04/200723/08/2007Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease.Safety and Efficacy of Melperone in the Treatment of Patients with Psychosis Associated with Parkinson's Disease. Psicosi associata al morbo di Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: Melperon
INN or Proposed INN: melperon
OVATION PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
90Italy
847EUCTR2006-002339-26-ES
(EUCTR)
19/04/200730/01/2007A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.Estudio de extensión abierto, multicéntrico para evaluar la seguridad, tolerabilidad y eficacia a largo plazo de E2007 como terapia complementaria en pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras. Levodopa treated Parkinson's disease patients with motor fluctuations.Pacientes con enfermedad de Parkinson tratados con Levodopa y fluctuaciones motoras
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
848EUCTR2006-002339-26-DE
(EUCTR)
10/04/200722/12/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;United Kingdom;Czech Republic;Germany;Estonia;Spain;Italy;Austria;Sweden;Lithuania
849NCT00623363
(ClinicalTrials.gov)
April 20072/1/2008Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's DiseaseParkinson's DiseaseDrug: piclozotan;Drug: 0.9% sodium chloride (normal saline)Asubio Pharmaceuticals, Inc.NULLCompleted40 Years85 YearsBoth27Phase 2United States;Guatemala;Romania
850NCT00466167
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
851NCT00438607
(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
852EUCTR2006-002937-20-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
853NCT01693081
(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
854EUCTR2006-002408-32-ES
(EUCTR)
27/02/200707/02/2007Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa.Modulación dopaminérgica de las funciones cognitivas y afectivas por el tratamiento con diferentes métodos de estimulación dopaminérgica en la enfermedad de Parkinson . Implicaciones para el tratamiento con levodopa. Fluctuaciones motoras, cognitivas y del humor en la enfermedad de Parkinson.
MedDRA version: 8.1;Level: PT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo 150
Product Name: Levodopa-carbidopa-entacapone
Trade Name: Sinemet
Product Name: Levodopa/Carbidopa
Institut de Recerca del Hospital de la Santa Creu i Sant PauNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Spain
855EUCTR2005-002038-36-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
856EUCTR2006-005183-91-LT
(EUCTR)
14/02/200720/12/2006An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian studyAn open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondrian study Advanced stage Parkinson's disease with motor fluctuations.
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
220Latvia;Lithuania
857EUCTR2006-005183-91-LV
(EUCTR)
02/02/200711/01/2007An open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan studyAn open label SLV308 safety extension to study S308.3.002 in patients with Parkinson’s disease experiencing motor fluctuations. - An extension of the Mondriaan study Advanced stage Parkinson's disease with motor fluctuations.Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Product Name: SLV308(mono)hydrochloride
Product Code: SLV308(mono)hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
140Latvia;Lithuania
858NCT00332917
(ClinicalTrials.gov)
February 20071/6/2006An Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD PatientsAn Open Label SLV308 Safety Extension to Study S308.3.001 in Early PD PatientsEarly Stage Parkinson's DiseaseDrug: PardoprunoxSolvay PharmaceuticalsNULLCompleted30 YearsN/ABoth224Phase 3United States;Argentina;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Finland;India;Israel;Mexico;New Zealand;Peru;Romania;Russian Federation;Serbia;Slovakia;South Africa;Sweden;Ukraine;Former Serbia and Montenegro
859NCT00427011
(ClinicalTrials.gov)
February 200724/1/2007A Study of E2007 In Patients With Parkinson's DiseaseA Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of E2007 In Patients With Parkinson's Disease Who Experience End-of-Dose Wearing-Off Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLTerminated18 YearsN/AAll25Phase 2United States
860EUCTR2006-003732-30-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
861EUCTR2006-000859-18-NL
(EUCTR)
25/01/200705/04/2007An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
247Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
862EUCTR2006-002339-26-HU
(EUCTR)
24/01/200724/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
863EUCTR2006-000678-57-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
864EUCTR2006-000859-18-PT
(EUCTR)
04/01/200718/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
865NCT00427674
(ClinicalTrials.gov)
January 200725/1/2007Assessment of the Biodistribution and Safety of 123-I MZINT in Healthy Subjects and Parkinson Disease PatientsPhase I Evaluation of (123-I)MZINT as a Brain SPECT Tracer of Serotonin Transporters in Healthy Human SubjectsParkinson DiseaseDrug: [123I] mZINT injection and serial dynamic SPECT imagingInstitute for Neurodegenerative DisordersMolecular NeuroImagingTerminated18 Years70 YearsBoth28Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
866NCT01187966
(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
867NCT00855686
(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
868EUCTR2006-000678-57-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
869EUCTR2006-002339-26-GB
(EUCTR)
28/12/200616/10/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;Czech Republic;United Kingdom;Estonia;Spain;Italy;Austria;Sweden;Lithuania
870EUCTR2005-002654-21-NO
(EUCTR)
28/12/200606/11/2006A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNEA long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.Trade Name: Duodopa intestinalgel
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
75Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
871EUCTR2006-000678-57-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
872EUCTR2006-005509-79-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
873EUCTR2006-005860-14-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
874EUCTR2006-000858-45-FI
(EUCTR)
18/12/200626/06/2006An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Finland;Sweden
875EUCTR2006-002937-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
876EUCTR2006-002937-20-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
877EUCTR2006-002937-20-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
878EUCTR2005-002038-36-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
879NCT01964573
(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
880EUCTR2005-002038-36-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
881NCT00406029
(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
882EUCTR2006-001755-36-GB
(EUCTR)
20/11/200629/09/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Orion Corporation Orion PharmaNULLNot Recruiting Female: yes
Male: yes
100Phase 4Germany;United Kingdom;Sweden
883EUCTR2006-004112-51-IT
(EUCTR)
14/11/200604/12/2006A randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - NDA randomised, double-blind, double-dummy, two-period, cross-over study to determine the pharmacokinetics, pharmacodynamics and safety of multiple doses of V1512 effervescent tablets in Parkinson s Disease PD patients compared to standard levodopa/carbidopa Sinemet oral tablets - ND Parkinson s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: SIRIO*30CPR EFF 25MG+100MG
INN or Proposed INN: Melevodopa and decarboxylase inhibitor
Trade Name: SINEMET*50CPR 100MG+25MG
INN or Proposed INN: LEVODOPA DC.IT FU
INN or Proposed INN: CARBIDOPA FU
VERNALIS DEVELOPMENT LIMITEDNULLNot RecruitingFemale: yes
Male: yes
Italy
884EUCTR2006-000678-57-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
885EUCTR2006-000859-18-LT
(EUCTR)
07/11/200607/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
886EUCTR2006-001793-24-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
887EUCTR2006-000678-57-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
888EUCTR2006-004582-33-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
889EUCTR2006-000678-57-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
890EUCTR2006-000859-18-EE
(EUCTR)
03/11/200601/09/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay pharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
891EUCTR2006-002937-20-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
892EUCTR2006-002339-26-CZ
(EUCTR)
01/11/200621/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
893NCT00400634
(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
894NCT00491998
(ClinicalTrials.gov)
November 200626/6/2007PK, PD and Safety of Multiple Doses of V1512 Tablets in PD Patients Compared to Standard Levodopa/Carbidopa Oral TabletsRandomised, Double-blind, Double-dummy, Two-period, Cross-over Study to Determine the PK, PD and Safety of Multiple Doses of V1512 Effervescent Tablets in Parkinson's Disease Patients Compared to Sinemet® Oral TabletsParkinson's DiseaseDrug: V1512;Drug: V1512 and EntacaponeVernalis (R&D) LtdCita NeuroPharmaceuticals;INC ResearchCompleted30 YearsN/ABoth27Phase 1;Phase 2Italy
895NCT00360308
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
896NCT00335166
(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
897NCT00468078
(ClinicalTrials.gov)
November 200630/4/2007Efficacy and Safety of F-18 FPCIT PET in Parkinson's Disease and Essential Tremor PatientsThe Single Center, Phase III Clinical Trial to Evaluate the Efficacy and the Safety of [18F]FPCIT Positron Emission Tomography in Parkinson's Disease and Essential Tremor PatientsParkinson's DiseaseProcedure: PET/CT;Drug: F-18 FPCITAsan Medical CenterNULLCompleted40 YearsN/ABoth78Phase 3Korea, Republic of
898EUCTR2005-002038-36-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
899EUCTR2006-002339-26-EE
(EUCTR)
20/10/200615/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
900EUCTR2006-002339-26-SE
(EUCTR)
19/10/200622/09/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Lithuania;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
901EUCTR2006-002339-26-BE
(EUCTR)
16/10/200624/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Czech Republic;Estonia;Spain;Belgium;Lithuania;Austria;Germany;Italy;United Kingdom;Sweden
902EUCTR2006-000858-45-SK
(EUCTR)
11/10/200628/09/2006An open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt studyAn open label SLV308 safety extension to study S308.3.001 in early PD patients. - An extension of the Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochlo
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Finland;Sweden
903EUCTR2006-002339-26-LT
(EUCTR)
05/10/200607/08/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
904NCT00360412
(ClinicalTrials.gov)
October 20062/8/2006A Study of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsA Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients With Motor FluctuationsParkinson's DiseaseDrug: E2007Eisai Inc.NULLTerminated30 YearsN/AMale997Phase 3Germany
905NCT00399477
(ClinicalTrials.gov)
October 200610/11/2006A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's DiseaseOpen-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD)Parkinson's DiseaseDrug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with RequipTeva Neuroscience, Inc.NULLCompleted30 YearsN/ABoth200Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
906EUCTR2006-002339-26-AT
(EUCTR)
25/09/200618/10/2006A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations.A Multi-centre, Open Label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 as an Adjunctive Therapy in Levodopa Treated Parkinson's Disease Patients with Motor Fluctuations. Levodopa treated Parkinson's disease patients with motor fluctuations.
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: MARS
Product Code: E2007
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
1400Portugal;Hungary;Germany;United Kingdom;Czech Republic;Estonia;Spain;Italy;Austria;Sweden;Lithuania
907EUCTR2005-002038-36-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
908EUCTR2006-000678-57-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
909EUCTR2005-005146-39-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
910EUCTR2006-000859-18-CZ
(EUCTR)
11/09/200602/08/2006An open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer studyAn open label SLV308 safety extension to study S308.3.003 in early PD patients - An extension to the Vermeer study Parkinson's Disease Early stageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochlori
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
225Portugal;Germany;Czech Republic;Netherlands;Estonia;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
911EUCTR2005-004949-34-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
912EUCTR2005-001006-12-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
913NCT00462007
(ClinicalTrials.gov)
September 200617/4/2007Study to Evaluate Initiation of Stalevo in Early Wearing-offEfficacy and Safety of Stalevo® in Subjects With Early Wearing-off Identified Using a Screening Tool WOQ-9; an Open, Non-randomised, Multinational, Multicentre 6-week Direct Switch Study in Levodopa-treated Parkinson's Disease PatientsParkinson's DiseaseDrug: StalevoOrion Corporation, Orion PharmaNULLCompleted35 YearsN/ABoth115Phase 4Germany;Sweden;United Kingdom
914EUCTR2005-006033-32-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
915EUCTR2006-001755-36-SE
(EUCTR)
09/08/200630/06/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion Pharma, FI-02200 Espoo, FinlandNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
916EUCTR2005-004314-33-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
917EUCTR2005-004949-34-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
918EUCTR2006-000678-57-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
919NCT00368108
(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
920EUCTR2006-001793-24-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
921EUCTR2006-000391-32-NL
(EUCTR)
18/07/200610/05/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Germany;United Kingdom;Netherlands
922EUCTR2006-000391-32-DE
(EUCTR)
04/07/200627/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's DiseaseProduct Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130United Kingdom;Germany;Netherlands
923NCT00408915
(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
924EUCTR2006-000361-11-GB
(EUCTR)
23/06/200601/02/2006A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201)A Proof of Concept Study to Determine the Minimum Effective Dose and to Assess the Efficacy and Safety of Subcutaneous Injections of FPFS-1169 in Parkinson's Disease Patients - Parkinson's Disease FPFS-1169 Proof of Concept Study (RD639/24201) Treatment of Parkinson's Disease
MedDRA version: 8.0;Classification code 10029205
Fujimoto Pharmaceutical CorporationNULLNot Recruiting Female: yes
Male: yes
10Phase 2United Kingdom
925EUCTR2005-004314-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
926EUCTR2005-004949-34-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
927EUCTR2005-006033-32-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
928EUCTR2006-000391-32-GB
(EUCTR)
06/06/200621/04/2006A 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's DiseaseA 2 Treatment Period Study with Period 1 Comprising a 3-Week Randomised, Double-Blind, Crossover Comparison of Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Combination with a 12-Week Open, Active, Efficacy, safety and Tolerability Assessment of APO Nasal Powder (2 and 4 mg) in the Alleviation of Acute Episodes of Motor Symptoms Associated with PD, Followed by Period 2 Comprising a 36-Week Open, Active Treatment, Safety Assessment of APO Nasal Powder (2 and 4 mg), in Subjects with PD. - Apomorphine Nasal Powder (2 and 4 mg) and Placebo in Subjects with Parkinson's Disease Alleviation of acute episodes of motor symptoms associated with Parkinson's Disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Apomorphine Nasal Powder
Other descriptive name: 6aß - apomorphine-10,11-diol hydrochloride hemihydrate
Britannia Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
130Phase 3Netherlands;Germany;United Kingdom
929NCT00269516
(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
930EUCTR2005-004949-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
931EUCTR2005-004314-33-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
932EUCTR2005-004949-34-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
933NCT00321854
(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
934EUCTR2005-005791-32-GB
(EUCTR)
24/04/200617/02/2006Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease.Chemical Safety/Tolerability of HF0220 and its Effect on Biochemical Markers Relevant to Patients with a Diagnosis of Mild to Moderate Alzheimer's Disease. HF0220 experimentally appears to exert its potential beneficial effects within the CNS and possibly other tissues by attenuating the adverse effects of oxidative stress. It is believed that this mechanism has the potential to reduce disease progression in a wide range of disorders of the nervous system, e.g. Alzheimer's and Parkinson's disease, and brain damage due to acute stroke and head injury. It may also apply to the protection of peripheral tissues, such as the heart and/or kidney.
MedDRA version: 9.1;Level: HLT;Classification code 10001897;Term: Alzheimer's disease (incl subtypes)
Hunter-Fleming LtdNULLNot Recruiting Female: yes
Male: yes
40Phase 2United Kingdom;Sweden
935EUCTR2005-006033-32-FI
(EUCTR)
20/04/200606/03/2006A Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt studyA Randomized, Double-blind, Placebo Controlled Parallel-group Fixed and Flexible SLV308 Dose Arm Study to Assess Efficacy and Safety of SLV308 Monotherapy in the Treatment of Patients with Early Stage Parkinson’s Disease - The Rembrandt study Parkinson's Disease Early StageProduct Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Product Name: SLV308 (mono) hydrochloride
Product Code: SLV308 (mono) hydrochloride
Other descriptive name: SLV308 (mono) hydrochloride
Solvay PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
440Finland;Slovakia;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
936EUCTR2005-004949-34-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
937EUCTR2005-001006-12-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
938NCT00461942
(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
939EUCTR2005-001006-12-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
940EUCTR2005-004314-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
941EUCTR2005-004314-33-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
942NCT00307450
(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
943NCT00282152
(ClinicalTrials.gov)
March 200623/1/2006Deep Brain Stimulation (DBS) for Early Stage Parkinson's Disease (PD)Safety and Tolerability of Neurostimulation in Early Stage Parkinson's DiseaseParkinson's DiseaseDevice: B-STN DBS;Drug: Optimal drug therapyVanderbilt University Medical CenterNULLCompleted50 Years75 YearsAll37N/AUnited States
944EUCTR2005-004290-19-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
945EUCTR2005-004314-33-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
946EUCTR2005-004314-33-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
947EUCTR2005-004314-33-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
948EUCTR2005-004314-33-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
949NCT00630500
(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
950NCT00296192
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
951NCT00286897
(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
952EUCTR2005-004314-33-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
953EUCTR2005-004290-19-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
954EUCTR2005-004314-33-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
955NCT01683292
(ClinicalTrials.gov)
January 20067/9/2012Single-Centre Study of VR040(Inhaled Apomorphine) in Idiopathic Parkinson's DiseaseAn Ascending-Dose, Single-Centre Study Investigating the Safety, Tolerability, Efficacy, and Pharmacokinetics of VR040(Inhaled Apomorphine)in Parkinson's DiseaseParkinson's DiseaseDrug: Inhaled VR040;Drug: Placebo for VR040South Glasgow University Hospitals NHS TrustVectura LimitedCompleted30 YearsN/ABoth29Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
956EUCTR2005-005120-13-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
957EUCTR2005-000444-84-GB
(EUCTR)
23/11/200513/09/2005An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OAn open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
958NCT00199381
(ClinicalTrials.gov)
October 200512/9/2005An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001An Open-Label Multicenter Study of the Continued Safety of Istradefylline (KW-6002) In Subjects With Parkinson's Disease Who Have Recently Completed One Year of Treatment With Istradefylline.Parkinson's DiseaseDrug: IstradefyllineKyowa Kirin Pharmaceutical Development, Inc.NULLTerminated30 YearsN/AAll504Phase 3United States
959NCT00517842
(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
960EUCTR2005-000444-84-FI
(EUCTR)
08/09/200526/07/2005An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OAn open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;United Kingdom;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
961NCT00165789
(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
962NCT00224263
(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
963EUCTR2005-002654-21-SE
(EUCTR)
08/08/200514/06/2005A long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNEA long-term health economics study of intraduodenal levodopa (Duodopa®) in routine care for patients with advanced idiopathic Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia. - DAPHNE Treatment of advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.Trade Name: Duodopa intestinal gel
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
Sweden
964EUCTR2004-002844-93-AT
(EUCTR)
20/07/200515/06/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa TherapyA Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy Parkinson's DiseaseProduct Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175Estonia;Spain;Lithuania;Austria;Latvia;Italy;United Kingdom
965EUCTR2004-000835-27-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
966EUCTR2005-004290-19-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
967EUCTR2005-000444-84-ES
(EUCTR)
12/07/200522/05/2006An open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-OAn open-label, multicenter, multinational Phase IIIfollow-up study to investigate the long-term safetyand efficacy of Sarizotan HCl 1 mg b.i.d. inpatients with Parkinson's disease suffering fromtreatment-associated dyskinesia (PADDY-O) - PADDY-O Treatment- Associated Dyskinesia in Parkinson´s DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Finland;United Kingdom;Spain;Italy
968EUCTR2004-002844-93-IT
(EUCTR)
06/07/200521/09/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients with Motor Response Complications on Levodopa Therapy. - Parkinson's Disease.
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: Istradefylline
Product Code: KW-6002
Other descriptive name: NA
KYOWA HAKKO UK LTDNULLNot RecruitingFemale: yes
Male: yes
United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
969NCT00125138
(ClinicalTrials.gov)
July 200527/7/2005Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's DiseaseSafety and Efficacy of Melperone in the Treatment of Patients With Psychosis Associated With Parkinson's DiseaseParkinson's Disease;Psychotic DisordersDrug: Melperone HCl;Drug: PlaceboLundbeck LLCNULLCompletedN/AN/AAll90Phase 2United States;India;Italy
970EUCTR2005-000444-84-AT
(EUCTR)
22/06/200518/05/2005An open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-OAn open-label, multicenter, multinational Phase III follow-up study to investigate the long-term safety and efficacy of Sarizotan HCl 1 mg b.i.d. in patients with Parkinson's disease suffering from treatment-associated dyskinesia - PADDY-O Treatment-Associated Dyskinesia in Parkinson's DiseaseProduct Code: EMD128130
INN or Proposed INN: Sarizotan hydrochloride
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
800Phase 3Finland;Spain;Austria;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
971EUCTR2005-004314-33-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
972NCT00148369
(ClinicalTrials.gov)
June 20056/9/2005A Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of LiaterminA Multi-Center, Observational Safety Registry of Subjects With Idiopathic Parkinson's Disease Previously Treated With Intraputaminal Infusion of LiaterminIdiopathic Parkinson's DiseaseDrug: Safety observationAmgenMedtronicCompleted35 Years70 YearsBoth31N/ACanada;United Kingdom;United States
973NCT00642889
(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
974EUCTR2004-002641-12-GB
(EUCTR)
16/05/200530/06/2005A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's diseaseA multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Spain;Austria;Italy;United Kingdom
975NCT00163085
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
976NCT00199433
(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
977EUCTR2004-002641-12-ES
(EUCTR)
25/04/200510/07/2006A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's diseaseA multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 3bUnited Kingdom;Spain;Italy
978EUCTR2004-000817-20-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
979EUCTR2004-002844-93-ES
(EUCTR)
01/04/200504/11/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
980EUCTR2004-001593-10-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
981EUCTR2004-002844-93-EE
(EUCTR)
08/03/200507/03/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
982NCT00203957
(ClinicalTrials.gov)
March 200513/9/2005Study of KW-6002 (Istradefylline) in Parkinson's Disease in Patients With Motor Response Complications on LevodopaA Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa TherapyParkinson's DiseaseDrug: IstradefyllineUniversity of ChicagoNULLCompleted18 YearsN/ABoth10Phase 3United States
983EUCTR2004-002844-93-LT
(EUCTR)
08/02/200503/01/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
984EUCTR2004-001594-25-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
985EUCTR2004-000817-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
986EUCTR2004-002844-93-GB
(EUCTR)
01/02/200523/02/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175Italy;Latvia;Lithuania;United Kingdom;Estonia;Spain
987NCT00505687
(ClinicalTrials.gov)
February 200520/7/2007An Open-Label Extension Trial to Assess the Safety and Tolerability of Long Term Treatment of Rotigotine in Subjects With Idiopathic Parkinson's DiseaseA Multicenter, Multinational, Phase 3b, Open-Label Extension Trial to Assess the Safety and Tolerability of Long-Term Treatment of Rotigotine Patch in Subjects With Idiopathic Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll186Phase 3United States;Austria;Germany;Israel;Italy;South Africa;Spain;United Kingdom
988EUCTR2004-002844-93-LV
(EUCTR)
28/01/200531/01/2005A Long-Term, Multicenter, Open-Label Safety Study with Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson’s Disease in Patients with Motor Response Complications on Levodopa Therapy - Parkinson's Disease Product Name: Istradefylline
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Kyowa Hakko U.K. LimitedNULLNot RecruitingFemale: yes
Male: yes
1175United Kingdom;Estonia;Spain;Italy;Latvia;Lithuania
989EUCTR2004-002641-12-AT
(EUCTR)
21/01/200517/12/2004A multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's diseaseA multicenter, multinational, phase 3b, open-label extension trial to assess the safety and tolerability of long-term treatment of rotigotine patch in subjects with idiopathic Parkinson's disease Parkinson's diseaseProduct Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Product Name: Rotigotine
Product Code: SPM 962
INN or Proposed INN: Rotigotine
Schwarz Biosciences GmbHNULLNot RecruitingFemale: yes
Male: yes
220Phase 3bSpain;Austria;Italy;United Kingdom
990NCT00144300
(ClinicalTrials.gov)
January 20052/9/2005Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) PatientsA Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease PatientsParkinson DiseaseDrug: Mirapex;Drug: RequipBoehringer IngelheimNULLCompleted30 YearsN/AAll246Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
991EUCTR2004-001594-25-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
992EUCTR2004-000817-20-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
993EUCTR2004-000835-27-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
994EUCTR2004-000833-12-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
995EUCTR2004-001593-10-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
996EUCTR2004-000833-12-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
997NCT00643045
(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
998EUCTR2004-001594-25-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
999NCT01518309
(ClinicalTrials.gov)
November 17, 200416/12/2008An Open-label Safety Study of Pimavanserin in Parkinson's Disease PatientsAn Open-Label Safety Study of Pimavanserin in Parkinson's Disease PatientsParkinson's Disease PsychosisDrug: pimavanserin tartrate (ACP-103)ACADIA Pharmaceuticals Inc.NULLCompletedN/AN/AAll39Phase 2United States
1000EUCTR2004-000817-20-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1001NCT01634360
(ClinicalTrials.gov)
November 20043/7/2012Long-Term Safety, Tolerability and Efficacy in Perampanel Treated Parkinson's Disease Patients With Motor FluctuationsA 48-month Open Label Multi-centered Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of E2007 in Patients With Parkinson's Disease With Wearing Off Motor Fluctuations and on Period DyskinesiasParkinson's DiseaseDrug: PerampanelEisai Inc.NULLTerminatedN/AN/AAll185Phase 2NULL
1002NCT00296946
(ClinicalTrials.gov)
November 200423/2/2006Ipratropium Spray for Drooling Saliva in Parkinson's DiseasePhase II Clinical Trial of Ipratropium Bromide Spray as a Treatment for Sialorrhea in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: ipratropium bromide (drug)University Health Network, TorontoParkinson's Disease FoundationCompleted30 YearsN/AAll20Phase 2Canada
1003NCT00199394
(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
1004EUCTR2004-000817-20-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
1005EUCTR2004-000361-35-IT
(EUCTR)
22/10/200423/05/2005A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS.A 12-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON'S DISEASE WITH WEARING OFF MOTOR FLUCTUATIONS AND ON PERIOD DYSKINESIAS. Parkinson's disease.
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: NA
Product Code: E2007
Other descriptive name: NA
EISAI LTD UKNULLNot RecruitingFemale: yes
Male: yes
Czech Republic;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1006EUCTR2004-000361-35-CZ
(EUCTR)
18/10/200422/10/2004A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS.A 48-MONTH OPEN LABEL MULTI-CENTERED EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF E2007 IN PATIENTS WITH PARKINSON’S DISEASE WITH WEARING OFF” MOTOR FLUCTUATIONS AND ON” PERIOD DYSKINESIAS. Parkinson's DiseaseProduct Name: MARS
Product Code: E2007
Other descriptive name: MARS
Other descriptive name: MARS
Other descriptive name: MARS
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
225Czech Republic;Italy
1007EUCTR2004-000148-26-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
1008EUCTR2004-000148-26-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
1009NCT00199368
(ClinicalTrials.gov)
October 200412/9/2005An Extension of Istradefylline in Parkinson's Disease Patients Who Have Completed Studies 6002-EU-007, 6002-US-013 or 6002-US-018A Long-Term, Multicenter, Open-Label Safety Study With Oral 20 or 40 mg/d Doses of KW-6002 (Istradefylline) as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa Therapy.Parkinson's DiseaseDrug: Istradefylline ( KW-6002)Kyowa Kirin Pharmaceutical Development, Inc.Kyowa Hakko Kirin UK, Ltd.Completed30 YearsN/ABoth1100Phase 3United States
1010NCT00105508
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1011EUCTR2004-000148-26-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
1012EUCTR2004-000817-20-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
1013EUCTR2004-003355-39-AT
(EUCTR)
14/09/200408/10/2004A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia.A 52-week, multicentre, open label extension study of the safety, tolerability and efficacy of donepezil (Aricept) in Parkinson's disease patients with dementia. Dementia associated with Parkinson's diseaseTrade Name: Aricept 5 mg-Filmtabletten
Product Name: Aricept 5mg-Filmtabletten
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
468Austria
1014NCT00099268
(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
1015NCT00105521
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1016NCT00501969
(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
1017EUCTR2004-000148-26-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
1018NCT00199420
(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
1019EUCTR2004-000148-26-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
1020NCT00203138
(ClinicalTrials.gov)
June 200413/9/2005Safety, Tolerability, and Effectiveness of Rasagiline Mesylate in Patients With Parkinson's DiseaseA Multicenter, Open-Label, Phase III Study for the Safety, Tolerability and Clinical Effect of Rasagiline Mesylate in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: rasagiline mesylateTeva Pharmaceutical IndustriesNULLCompleted35 YearsN/ABoth306Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1021NCT00199407
(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
1022NCT03091543
(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
1023NCT01172379
(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
1024NCT00244387
(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
1025NCT00632736
(ClinicalTrials.gov)
February 20044/3/2008An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s DiseaseAn Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169Parkinson Disease;Parkinson's DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll419Phase 3United States;Belgium;Czech Republic;France;Hungary;Italy;Poland;Spain;United Kingdom;Germany;Philippines
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1026NCT02231905
(ClinicalTrials.gov)
January 20043/9/2014Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's DiseaseOpen Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to PramipexoleParkinson DiseaseDrug: BI-Sifrol®Boehringer IngelheimNULLCompleted20 YearsN/ABoth29Phase 4NULL
1027NCT00220272
(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
1028NCT00234676
(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
1029NCT00228150
(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
1030NCT00160576
(ClinicalTrials.gov)
July 20038/9/2005Levetiracetam Treatment in Adult Subjects With Parkinson's Disease Experiencing Troublesome DyskinesiasA Therapeutic Exploratory, Single Arm, Multicenter Trial to Evaluate the Efficacy and Safety of Levetiracetam up to 4000 mg/Day (500mg Oral Tablets) on Levodopa Induced Dyskinesias in Adults With Idiopathic Parkinson's DiseaseIdiopathic Parkinson DiseaseDrug: LevetiracetamUCB PharmaNULLCompleted30 YearsN/ABoth30Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1031NCT00095810
(ClinicalTrials.gov)
July 20039/11/2004Aripiprazole in Patients With Psychosis Associated With Parkinson's DiseaseAn Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's DiseaseParkinson's Disease;PsychosesDrug: aripiprazoleOtsuka Pharmaceutical Development & Commercialization, Inc.Otsuka America PharmaceuticalCompleted50 YearsN/ABoth50Phase 4United States
1032NCT00070941
(ClinicalTrials.gov)
July 20039/10/2003SAM-e for the Treatment of Depression in Patients With Parkinson's DiseaseSAM-e Treatment of Depression in Parkinson's Disease.Parkinson's Disease;DepressionDrug: SAM-e;Drug: oral escitalopram;Drug: placeboNew York University School of MedicineNational Center for Complementary and Integrative Health (NCCIH);Office of Dietary Supplements (ODS)Completed30 Years80 YearsAll29Phase 2;Phase 3United States
1033NCT00148486
(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
1034NCT00058838
(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
1035NCT00148512
(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
1036NCT01327859
(ClinicalTrials.gov)
March 200330/3/2011Safety, Tolerability, and Efficacy of Donepezil (Aricept) in Parkinson' s Disease (PD) Patients With DementiaA 52-week, Multicentre Open Label Extension Study of the Safety Tolerability and Efficacy of Donepezil (Aricept) in Parkinson's Disease (PD) Patients With DementiaParkinson's Disease;DementiaDrug: Prior Donepezil 5mg;Drug: Prior Donzepezil 10mg;Drug: Prior PlaceboEisai Inc.NULLCompleted40 YearsN/ABoth357Phase 3United Kingdom
1037NCT00056524
(ClinicalTrials.gov)
February 200315/3/2003Safety Study of AVP-923 in the Treatment of IEED (Involuntary Emotional Expression Disorder) Also Known as Pseudobulbar Affect (Episodes of Uncontrolled Crying and/or Laughter)An Open-Label Multicenter Study to Assess the Safety of AVP-923 in the Treatment of Patients With Pseudobulbar Affect.Alzheimer's Disease;Stroke;Parkinson's Disease;Traumatic Brain InjuryDrug: AVP-923Avanir PharmaceuticalsNULLCompleted18 Years80 YearsBoth600Phase 3United States
1038NCT00206687
(ClinicalTrials.gov)
January 200313/9/2005STEPS Trial - Spheramine Safety and Efficacy StudyStudy of the Safety, Tolerability and Efficacy of Spheramine Implanted Bilaterally Into the Postcommissural Putamen of Patients With Advanced Parkinson's DiseaseParkinson DiseaseBiological: Spheramine (BAY86-5280);Procedure: PlaceboBayerTitan PharmaceuticalsTerminated30 Years70 YearsBoth71Phase 2United States;Germany;Spain;Austria;France
1039NCT00599196
(ClinicalTrials.gov)
August 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP513 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's DiseaseEarly Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted30 YearsN/AAll381Phase 3Australia;Austria;Belgium;Croatia;Czech Republic;Finland;France;Germany;Hungary;Israel;Italy;Netherlands;New Zealand;Norway;Poland;South Africa;Spain;Sweden;Switzerland;United Kingdom
1040NCT00594386
(ClinicalTrials.gov)
August 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's DiseaseAn Open-Label Extension to the Double-Blind SP650 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Advanced-Stage Idiopathic Parkinson's Disease.Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll258Phase 3United States;Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1041NCT00955045
(ClinicalTrials.gov)
August 20024/8/2009A Long-Term, Safety Study With a Flexible Dose Range of KW-6002 in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyA Long-Term, Multicenter, Open-Label, Safety Study With a Flexible Dose Range of KW-6002 as Treatment for Parkinson's Disease in Patients With Motor Response Complications on Levodopa/Carbidopa TherapyParkinson's DiseaseDrug: istradefyllineKyowa Kirin Pharmaceutical Development, Inc.NULLCompleted30 YearsN/ABothPhase 2;Phase 3United States
1042NCT00165815
(ClinicalTrials.gov)
August 200213/9/2005The Efficacy, Tolerability and Safety of Donepezil (Aricept) in Parkinson's Disease Patients With DementiaDementia With Parkinson's DiseaseDrug: ARICEPTEisai LimitedNULLCompleted40 YearsN/ABothPhase 3Germany;Ireland
1043NCT00314288
(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
1044NCT00594165
(ClinicalTrials.gov)
June 200224/12/2007An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Early-Stage Parkinson's Disease.An Open-Label Extension to the Double-Blind SP512 Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Subjects With Early-Stage Idiopathic Parkinson's Disease.Early-Stage Parkinson's DiseaseDrug: RotigotineUCB PharmaNULLCompleted31 YearsN/AAll217Phase 3United States;Canada
1045NCT00203164
(ClinicalTrials.gov)
May 200213/9/2005Study to Evaluate the Safety and Tolerability of Rasagiline in Advanced Parkinson's Disease PatientsA Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa TherapyParkinson's DiseaseDrug: rasagiline mesylateTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth254Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1046NCT00040404
(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
1047NCT00407212
(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
1048NCT00036218
(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
1049NCT00203177
(ClinicalTrials.gov)
October 200113/9/2005Rasagiline in Advanced Parkinson's Disease Patients With Motor Fluctuations Treated With Levodopa/Carbidopa Therapy.A Bi-national, Multicenter, Double-Blind, Randomized Study to Evaluate the Safety and Tolerability of Rasagiline Mesylate in Advanced Parkinson's Disease (PD) Patients With Motor Fluctuations Treated With Chronic Levodopa/Carbidopa Therapy.Parkinson's DiseaseDrug: rasagiline mesylate;Drug: rasagiline mesylate 1.0 mgTeva Pharmaceutical IndustriesNULLCompleted30 YearsN/ABoth254Phase 3United States;Canada
1050NCT00200525
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1051NCT02763800
(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
1052NCT00036205
(ClinicalTrials.gov)
August 20008/5/2002Open Label Sumanirole Study of Safety, Tolerability, and Therapeutic Response In Patients With Parkinson's DiseaseOpen-Label, Long Term, Flexible Dose Study Of Safety, Tolerability, And Therapeutic Response In Patients With Parkinson's Disease.Parkinson DiseaseDrug: sumanirolePfizerNULLTerminated30 YearsN/ABoth984Phase 3United States;Argentina;Colombia;Puerto Rico
1053NCT00203034
(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
1054NCT02763787
(ClinicalTrials.gov)
April 20004/5/2016Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of BIA 3-202A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics (Including Food Interaction), and Pharmacodynamics of Single Doses of BIA 3-202 in Healthy Volunteers.Parkinson's DiseaseDrug: BIA 3-202;Drug: PlaceboBial - Portela C S.A.NULLCompleted18 Years35 YearsMale71Phase 1United Kingdom
1055NCT00761436
(ClinicalTrials.gov)
February 200026/9/2008Pilot Study of Safety and Efficacy of SpheramineStereotactic Intrastriatal Implantation of Spheramine in Advanced Parkinson's Disease Patients: A Pilot Study of Tolerability and Efficacy.Parkinson's DiseaseBiological: Spheramine (BAY86-5280)BayerTitan PharmaceuticalsTerminated40 Years70 YearsBoth6Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1056NCT00200512
(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
1057NCT00142545
(ClinicalTrials.gov)
July 199931/8/2005Long Term Safety and Efficacy of SC Apomorphine in Treatment of Off Episodes in Late-Stage Parkinson's DiseaseLong-Term Safety and Effectiveness of Subcutaneous Injections of Apomorphine in the Treatment of Off” Episodes in Patients With On-Off” or Wearing-Off” Effects Associated With Late-Stage Parkinson’s DiseaseParkinson DiseaseDrug: apomorphine HCl injectionMylan Bertek PharmaceuticalsNULLCompleted18 YearsN/ABoth800Phase 3United States
1058NCT02172573
(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
1059NCT02177357
(ClinicalTrials.gov)
November 199824/6/2014Pramipexole in Untreated and Levodopa-treated Parkinson's Disease PatientsPramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational StudyParkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted30 YearsN/ABoth150Phase 3NULL
1060NCT02233023
(ClinicalTrials.gov)
June 19984/9/2014Ophthalmologic Safety of Long Term Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's DiseaseMatched Pair, Assessor Blinded, Open Label Clinical Trial to Assess the Ophthalmologic Safety of Long Term Oral Treatment With Pramipexole Compared to Bromocriptine or Other Dopamine Agonists in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole;Drug: Bromocriptine and other dopamine agonistsBoehringer IngelheimNULLCompletedN/AN/ABoth705Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1061NCT00226460
(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
1062NCT00203060
(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
1063JPRN-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
1064EUCTR2011-002073-30-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
1065EUCTR2008-004447-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1066EUCTR2006-001755-36-DE
(EUCTR)
15/08/2006Efficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSEEfficacy and safety of Stalevo in subjects with early wearing-off identified using a screening tool WOQ-9; An open, non-randomised, multinational, multi-centre 6-week direct switch study in levodopa-treated Parkinson's disease patients - SENSE Parkinson’s disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Trade Name: Stalevo
Product Name: Stalevo
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
INN or Proposed INN: Entacapone
Orion Corporation Orion PharmaNULLNot RecruitingFemale: yes
Male: yes
100United Kingdom;Germany;Sweden
1067EUCTR2009-013552-72-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
1068EUCTR2010-022200-46-DE
(EUCTR)
13/04/2011Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®) in patients with Pakinson’s disease.Efficacy and safety of ODM-101 compared to a standard combination (Stalevo®); a randomised, double-blind, crossover, proof of concept study in patients with Parkinson’s disease and end-of-dose motor fluctuations. - PARPOC Parkinson's disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ODM-101
Product Code: 75
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 100
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
INN or Proposed INN: ENTACAPONE
Other descriptive name: na
Product Name: ODM-101
Product Code: 125
INN or Proposed INN: LEVODOPA
Other descriptive name: na
INN or Proposed INN: CARBIDOPA
Other descriptive name: na
Orion CorporationNULLNot RecruitingFemale: yes
Male: yes
100Finland;Lithuania;Latvia;Germany
1069EUCTR2008-005492-94-DE
(EUCTR)
11/08/2009Open-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease PatientsOpen-Label trial to Determine the Long-term Safety of Safinamide in Parkinson's Disease Patients Idiopathic Parkinson's Disease
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Product Name: Safinamide
Product Code: NW-1015
INN or Proposed INN: safinamide
Newron PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
1285United States;Portugal;Taiwan;Estonia;Slovakia;Spain;Thailand;Chile;Colombia;Italy;India;France;Malaysia;Peru;South Africa;Netherlands;Korea, Republic of;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand
1070EUCTR2016-000657-12-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