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"
537 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04468919
(ClinicalTrials.gov)
July 1, 20218/7/2020Optimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitOptimizing BCI-FIT: Brain Computer Interface - Functional Implementation ToolkitAmyotrophic Lateral Sclerosis;Brainstem Stroke;Muscular Dystrophies;Parkinson's Disease and Parkinsonism;Multiple System Atrophy;Brain Tumor Adult;Spinal Cord Injuries;Locked-in SyndromeBehavioral: BCI-FIT multi-modal access;Behavioral: BCI-FIT adaptive signal modeling;Behavioral: BCI-FIT active querying;Behavioral: BCI-FIT language modelingOregon Health and Science UniversityNULLNot yet recruiting18 Years75 YearsAll60N/AUnited States
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
3EUCTR2019-004235-23-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
4EUCTR2019-002952-17-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
5NCT04435431
(ClinicalTrials.gov)
October 29, 202015/6/2020A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced DyskinesiaA Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Mesdopetam;Drug: PlaceboIntegrative Research Laboratories ABNULLRecruiting30 Years79 YearsAll140Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-003796-17-GB
(EUCTR)
22/10/202001/09/2020A study to look at the effect of CST-103 or CST-139 on blood flow in the brain and on memory.An Open-Label Brain Imaging and Cognition Study to Determine Changes in Cerebral Perfusion and Cognition After Oral Administration of CST-103 or CST-139 Patients with Mild Cognitive Impairment or Parkinson’s Disease
MedDRA version: 21.1;Level: LLT;Classification code 10009846;Term: Cognitive impairment;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Spiropent
Product Name: Clenbuterol HCl
Product Code: CST-103
INN or Proposed INN: CLENBUTEROL HYDROCHLORIDE
Trade Name: Berachin
Product Name: Tulobuterol
Product Code: CST-139
INN or Proposed INN: Tolubuterol Hydrochloride
Other descriptive name: TULOBUTEROL HYDROCHLORIDE
CuraSen Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2United Kingdom
7NCT04593511
(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
8NCT04338997
(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
9NCT04591535
(ClinicalTrials.gov)
September 28, 202011/9/2020PK Study of WD-1603 in Healthy SubjectsAn Open Label, Balanced, Randomised, Four-treatment, Four-period, Four-sequence, Single Oral Dose, Crossover PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fed ConditionsParkinson DiseaseDrug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
10NCT04553978
(ClinicalTrials.gov)
September 18, 202013/9/2020A Single Oral Dose, Crossover Comparative PK Study of WD-1603 in Healthy Subjects Under Fasting ConditionsAn Open Label, Balanced, Randomised, 2-treatment, 2-period, 2-sequence, Single Oral Dose, Corssover Comparative PK Study of WD-1603 in Normal, Healthy, Adult Human Subjects Under Fasting ConditionsParkinson DiseaseDrug: WD-1603Hong Kong WD Pharmaceutical Co., LimitedNULLNot yet recruiting18 Years45 YearsAll8Phase 1NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2019-004235-23-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
12NCT04476017
(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
13EUCTR2019-004235-23-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
14NCT04513340
(ClinicalTrials.gov)
August 13, 202012/8/2020WD-1603 PK Study Under Fasting and Fed Conditions in Healthy SubjectsAN OPEN LABEL, BALANCED, RANDOMISED, FOUR-TREATMENT, FOUR-PERIOD, FOUR-SEQUENCE, SINGLE INTRA-ORAL AND ORAL DOSE, CROSSOVER PHARMACOKINETICS STUDY OF WD-1603 EXTENDED-RELEASE CARBIDOPA/LEVODOPA TABLETS 25/100MG IN NORMAL, HEALTHY, ADULT HUMAN SUBJECTS UNDER FASTING AND FED CONDITIONSParkinson DiseaseDrug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETSHong Kong WD Pharmaceutical Co., LimitedNULLRecruiting18 Years45 YearsAll8Phase 1India
15NCT04483479
(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
16NCT04630860
(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
17NCT04384666
(ClinicalTrials.gov)
June 2, 20208/5/2020A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersA Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersParkinson DiseaseDrug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal PatchLuye Pharma Group Ltd.NULLCompleted18 Years45 YearsAll56Phase 1United States
18NCT04379050
(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
19EUCTR2018-002144-85-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
20EUCTR2018-002233-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04167540
(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
22NCT04291859
(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
23NCT04292223
(ClinicalTrials.gov)
February 10, 202028/2/2020Open-Label Study With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisA 16-Week Open-Label Study of the Effects of Treatment With Pimavanserin on Activities of Daily Living in Subjects With Parkinson's Disease PsychosisParkinson Disease PsychosisDrug: PimavanserinACADIA Pharmaceuticals Inc.NULLRecruiting40 YearsN/AAll53Phase 4United States
24EUCTR2018-002234-21-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
25NCT04295642
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT04127578
(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
27NCT04301492
(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
28NCT03815916
(ClinicalTrials.gov)
December 19, 201918/1/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Parkinson's DiseaseA Phase 2, Pilot Open Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Parkinson's DiseaseParkinson's DiseaseDrug: Gold NanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterRecruiting30 Years80 YearsAll30Phase 2United States
29NCT04175132
(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
30EUCTR2018-002233-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04575259
(ClinicalTrials.gov)
October 10, 201929/9/2020OLE Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001Open Label Extension Study for Patients With Parkinson's Disease With Dementia Enrolled in Study ANAVEX2-73-PDD-001Parkinson Disease DementiaDrug: ANAVEX2-73Anavex Life Sciences Corp.Anavex Australia Pty Ltd.;Anavex Germany GmbHRecruiting50 Years85 YearsAll120Phase 2Australia;Spain
32EUCTR2018-002234-21-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
33EUCTR2018-002144-85-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
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Spain;Denmark;Australia;Netherlands;United Kingdom;Japan
34EUCTR2018-002234-21-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
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
35EUCTR2018-002144-85-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
36JPRN-UMIN000037421
2019/08/0101/08/2019A study on improvement of cognitive function by istradefylline for parkinson diseaseAn open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - A study on improvement of cognitive function by istradefylline for parkinson disease Parkinson diseasePrescription istradefylline 20 mg for 1 month. If there are no side effects, We increase to 40 mg and prescribe for 2 months.
The assessments will be made in all patients participating the study, patients with MMSE scores of 26 or more, patients with MMSE score of less than 26.
Ichinomiya Nishi HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
37JPRN-UMIN000037422
2019/08/0101/08/2019An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson diseaseAn open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease - An open-labeled single arm study on improvement of cognitive function by istradefylline for parkinson disease Parkinson diseasePrescription istradefylline 20 mg for 1 month, and if there are no side effects, increase to 40 mg and prescribe for 2 months.Ichinomiya Nishi HospitalNULLRecruiting40years-old85years-oldMale and Female25Not selectedJapan
38EUCTR2018-002144-85-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
39EUCTR2018-002144-85-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
40EUCTR2018-002144-85-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-002234-21-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
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Estonia;Spain;Ukraine;Lithuania;United Kingdom;Italy;France;Czech Republic;Poland;Romania;Germany;Latvia
42NCT03938922
(ClinicalTrials.gov)
June 13, 201918/4/2019A Study to Evaluate ENT-01 for the Treatment of Parkinson's Disease DementiaA Multicenter, Open Label Study to Evaluate Tolerability and Efficacy of Orally Administered ENT-01 for the Treatment of Parkinson's Disease Dementia.Parkinson Disease;DementiaDrug: Active Investigational Treatment ENT-01Enterin Inc.NULLActive, not recruiting30 Years90 YearsAll40Phase 1United States
43NCT04389762
(ClinicalTrials.gov)
June 4, 201930/4/2020PS128 May Improve Off Duration on Parkinson's DiseaseLactobacillus Plantarum PS128 May Improve Off Duration in Parkinson's Disease: a Pilot StudyParkinson DiseaseDietary Supplement: daily ingestion of Lactobacillus plantarum PS128Professor Lu Neurological ClinicNULLCompleted40 Years80 YearsAll60N/ATaiwan
44NCT04293159
(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
45NCT03781167
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46JPRN-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
47EUCTR2018-002233-37-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
48NCT03877510
(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
49NCT03887884
(ClinicalTrials.gov)
March 5, 20191/3/2019Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder)Randomized, Multi-center, Open-label, Crossover Pharmacokinetic Study of CVT-301 (Levodopa Inhalation Powder) and an Oral Dose of Carbidopa/Levodopa CD/LD Under Fed Conditions in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: CVT-301;Drug: SinemetAcorda TherapeuticsNULLCompleted30 Years85 YearsAll23Phase 1United States
50NCT03820037
(ClinicalTrials.gov)
March 201925/1/2019Relative Bioavailability and Bioequivalence of OpicaponeA Phase I, Open-Label, Randomised, Three-Period, Three-Sequence, Partial Replicate Crossover Study to Investigate the Relative Bioavailability and Bioequivalence of Opicapone Obtained From Two Different Sources, Under Fasting Conditions After Single-dose Administration in Healthy SubjectsParkinson DiseaseDrug: Ongentys;Drug: BIA 9-1067 (test)Bial - Portela C S.A.NULLNot yet recruiting18 Years55 YearsAll45Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03968744
(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
52EUCTR2017-003458-18-SE
(EUCTR)
23/01/201910/12/2018A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaA randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia Parkinson's disease dyskinesia
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Integrative Research Laboratories AB (IRLAB)NULLNot Recruiting Female: yes
Male: yes
74 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSweden
53NCT03826134
(ClinicalTrials.gov)
January 17, 201930/1/2019A Positron Emission Tomography (PET) Study to Examine the Brain Binding Properties of a Novel Radioactive Compound [11C]-PXT012253 in Healthy SubjectsInterventional, Phase I, Open-label, First in Human, Single-center Positron Emission Tomography (PET) Study Investigating Test-retest Properties of [11C]-PXT012253 as a Radiotracer in Healthy SubjectsParkinson DiseaseDrug: [11C]PXT012253H. Lundbeck A/SNULLCompleted20 Years50 YearsAll7Early Phase 1Sweden
54NCT03391882
(ClinicalTrials.gov)
December 19, 20182/1/2018A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations (OFF Episodes)An Open-Label, Randomized, Crossover Trial Utilizing a Single-Blinded Rater to Evaluate APL-130277 Compared to Subcutaneous Apomorphine in Levodopa Responsive Subjects With Parkinson's Disease Complicated by Motor FluctuationsMotor OFF Episodes Associated With Parkinson's DiseaseDrug: APL-130277;Drug: subcutaneous apomorphineSunovionNULLRecruiting18 YearsN/AAll106Phase 3Austria;France;Germany;Italy;Spain;United Kingdom
55NCT03944447
(ClinicalTrials.gov)
December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, MedicalOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT03639064
(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
57NCT03733561
(ClinicalTrials.gov)
November 9, 20186/11/2018A Study to Assess Pharmacokinetic Profiles of LY03003 and NeuproA Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetic Profiles of Rotigotine After a Single Dose of LY03003 (28 mg) Versus After a Week of Daily NEUPRO® Transdermal Patch (4 mg Every 24 Hours) in Healthy VolunteersParkinson DiseaseDrug: LY03003;Drug: Neupro 4Mg/24Hr Transdermal PatchLuye Pharma Group Ltd.NULLRecruiting18 Years45 YearsAll40Phase 1United States
58NCT03670953
(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
59NCT03648905
(ClinicalTrials.gov)
September 6, 201824/8/2018Clinical Laboratory Evaluation of Chronic Autonomic FailureClinical Laboratory Evaluation of Chronic Autonomic FailureParkinson's Disease;Multiple System Atrophy;Autonomic FailureDrug: 18F-Dopa;Drug: 11C-methylreboxetine;Drug: 13N-Ammonia;Drug: 18F-Dopamne;Drug: Desipramine (DMI)National Institute of Neurological Disorders and Stroke (NINDS)NULLRecruiting18 YearsN/AAll140Phase 1United States
60NCT03621046
(ClinicalTrials.gov)
August 20, 20186/6/2018Use of Low-dose Zolpidem in Parkinson's DiseaseA Placebo Controlled Double Blind Randomised Controlled Proof of Concept Study of Zolpidem for the Treatment of Motor and Cognitive Deficits in Late-stage Parkinson'sParkinson DiseaseDrug: Zolpidem;Other: PlaceboAston UniversityUniversity Hospital Birmingham NHS Foundation TrustCompleted40 Years80 YearsAll28Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03773796
(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
62NCT03521635
(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
63NCT03566589
(ClinicalTrials.gov)
July 2, 201812/6/2018Effects of PS128 on Parkinsonian SymptomsEffects of Lactobacillus Plantarum PS128 on the Parkinsonian Symptoms in Parkinson's Disease: a Pilot StudyParkinson DiseaseDietary Supplement: Lactobacillus plantarum PS128Professor Lu Neurological ClinicNULLCompleted40 Years80 YearsAll30N/ATaiwan
64NCT03576638
(ClinicalTrials.gov)
July 201825/6/2018Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease PatientsAn Open Label Phase 2 Study to Assess the Pharmacokinetics of the Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseParkinson DiseaseDrug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release TabletIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll12Phase 2NULL
65EUCTR2017-004006-18-NL
(EUCTR)
07/06/201815/11/2017The effect of inhaled levodopa on the recovery from off periods in patients with Parkinson's diseaseTherapeutic effects of an inhaled levodopa dry powder formulation on the recovery from off periods in patients with Parkinson's disease - Effectiveness of inhaled levodopa in Parkinson's disease Parkinson's disease is a progressive neurodegenerative disorder characterized by a lack of dopamine production due to the loss of dopamine producing cells in the substantia nigra. This lack of dopamine causes disruption of motor circuits in the brain resulting in motor function impairments like tremor, rigidity and bradykinesia.
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Levodopa powder for inhalation
Product Code: Levodopa Cyclops
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Trade Name: Madopar 125 mg, orodispersible tablet
Pharmaceutical Technology and Biopharmacy, University of GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
8Phase 2Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2017-002780-17-ES
(EUCTR)
21/05/201812/02/2018Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the blood levels of Levodopa Administered as ND0612 via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Duodopa.A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension Parkinson’s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ND0612
Product Code: ND0612
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET Plus
Product Name: SINEMET
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
Trade Name: Duodopa LD/CD 20/5 mg/mL
Product Name: Duodopa LD/CD 20/5 mg/mL
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: carbidopa
Other descriptive name: CARBIDOPA
NeuroDerm Ltd.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3France;United States;Spain;Austria;Netherlands;Italy
67NCT03589066
(ClinicalTrials.gov)
May 15, 20188/6/2018Pharmacokinetic Study of LY03003 in Patients With Parkinson's DiseaseAn Open-label, Randomized, Parallel-group Trial to Evaluate the Pharmacokinetics of Two Formulations of LY03003 After a Single Intramuscular Injection Administered to Patients With Parkinson's DiseaseParkinson DiseaseDrug: LY03003Luye Pharma Group Ltd.NULLCompleted18 YearsN/AAll24Phase 1United States
68EUCTR2017-002780-17-FR
(EUCTR)
26/04/201827/02/2018-A Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson’s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension Parkinson’s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
NeuroDerm Ltd.NULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Austria;Netherlands;Italy
69NCT03374917
(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
70EUCTR2017-004253-16-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
48 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noAustria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03368170
(ClinicalTrials.gov)
April 12, 20185/12/2017Efficacy and Tolerability of IRL790 in Parkinson's Disease DyskinesiaA Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease DyskinesiaParkinson DiseaseDrug: Mesdopetam (IRL790)Integrative Research Laboratories ABThe Clinical Trial CompanyCompleted18 Years79 YearsAll75Phase 2Sweden;United Kingdom
72EUCTR2017-002780-17-IT
(EUCTR)
10/04/201804/11/2020study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered as subcutaneous infusionA Pivotal, Open-Label, Randomized, Crossover, Four Sequences Study in Male and Female Patients with Advanced Parkinson¿s Disease to Assess the Relative Bioavailability of Levodopa Administered as ND0612 Subcutaneous Infusion via a Pump System plus Additional Oral Administered Levodopa/Carbidopa versus Levodopa Administered as Carbidopa-Levodopa Enteral Suspension - study in patients with Parkinson's disease to evaluate the bioavailability of levodopa administered Parkinson¿s Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET Plus
Product Name: SINEMET
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Trade Name: Duodopa LD/CD 20/5 mg/mL
Product Name: Duodopa LD/CD 20/5 mg/mL
INN or Proposed INN: LEVODOPA
Other descriptive name: levodopa
INN or Proposed INN: CARBIDOPA
Other descriptive name: carbidopa
Product Name: ND0612
Product Code: ND0612
INN or Proposed INN: CARBIDOPA
Other descriptive name: carbidopa
INN or Proposed INN: LEVODOPA
Other descriptive name: levodopa
NEURODERM LTD.NULLNot RecruitingFemale: yes
Male: yes
50Phase 3United States;France;Spain;Austria;Netherlands;Italy
73EUCTR2016-003456-70-DE
(EUCTR)
04/04/201803/04/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 22.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomor
Sunovion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;United Kingdom;Italy
74EUCTR2017-004297-34-GB
(EUCTR)
31/03/201822/06/2018Use of low-dose zolpidem in Parkinson's.A placebo controlled double blind randomised controlled proof of concept study of zolpidem for the treatment of motor and cognitive deficits in late-stage Parkinson’s - Zolpidem for treatment of motor and cognitive deficits in Parkinson's Parkinson's Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Stilnoct
Product Name: Stilnoct
Product Code: 207-3120
INN or Proposed INN: Zolpidem Tartrate
Aston UniversityNULLNot RecruitingFemale: yes
Male: yes
28Phase 2United Kingdom
75NCT03482882
(ClinicalTrials.gov)
March 9, 201823/3/2018Safety and Efficacy of Pimavanserin in Adults With Parkinson's Disease and DepressionAn Open-label, 8-Week Study of Safety and Efficacy of Pimavanserin Treatment in Adults With Parkinson's Disease and DepressionTreatment of Depression in Adults With Parkinson's Disease (PD)Drug: PimavanserinACADIA Pharmaceuticals Inc.NULLCompleted50 YearsN/AAll47Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT04265027
(ClinicalTrials.gov)
February 20, 20187/2/2020Bioavailability and Bioequivalence Between Two Active Pharmaceutical Ingredient (API) Sources of Opicapone (OPC)An Open Label, Randomised, Two Period, Crossover Study to Assess Bioavailability, Bioequivalence and S COMT Activity Between Two Active Pharmaceutical Ingredient Sources of Opicapone at Two Different Dosage Strengths (50 mg and 25 mg) After Single and Multiple Dose Administrations Under Fasting Conditions in Healthy Volunteers.Parkinson DiseaseDrug: 50 mg BIA 9 1067;Drug: 25 mg BIA9 1067;Drug: 50 mg Ongentys;Drug: 25 mg OngentysBial - Portela C S.A.NULLCompleted18 Years55 YearsAll72Phase 1United Kingdom
77NCT03419806
(ClinicalTrials.gov)
February 16, 201810/1/2018Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal Duodopa in Patients With Parkinson's DiseaseLevodopa Pharmacokinetics in Patients With Parkinson's Disease and Symptom Fluctuation: A Phase I, Open-label, Randomized, Multicentre, Crossover Study Comparing Intravenous and Subcutaneous Infudopa With Intestinal DuodopaParkinson DiseaseDrug: Infudopa i.v.;Drug: Infudopa s.c.;Drug: LCIG (Duodopa)Vastra Gotaland RegionThe Swedish Research Council;Dizlin Medical Design AB;Göteborg UniversityCompleted30 YearsN/AAll25Phase 1Sweden
78NCT03496870
(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
79EUCTR2016-003456-70-ES
(EUCTR)
06/02/201807/12/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
85Phase 3Spain;Austria;United Kingdom
80EUCTR2016-000637-43-ES
(EUCTR)
06/02/201807/12/2017Safety, tolerability and efficacy study to examine APL-130277 in patients with Parkinson’s Disease.An Open-Label, Phase 3 Study Examining the Long-Term Safety, Tolerability and Efficacy of APL-130277 in Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF” Episodes). Levodopa Responsive Patients with Parkinson’s Disease complicated by Motor Fluctuations (OFF” Episodes)
MedDRA version: 20.0;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
450Phase 3France;United States;Canada;Spain;Austria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2016-000637-43-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
82EUCTR2016-001403-23-HU
(EUCTR)
23/01/201822/01/201812-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;Hungary;Slovakia;European Union;Greece;Finland;Spain
83EUCTR2016-003456-70-AT
(EUCTR)
04/01/201816/11/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-Blinded Rater to evaluate APL-130277 compared to s.c. Apomorphine in Levodopa Responsive Subjects with Parkinson’s Disease Complicated by Motor Fluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
106 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Austria;Germany;Italy;United Kingdom
84EUCTR2017-000087-15-DE
(EUCTR)
21/12/201717/05/2017A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants with Early Parkinson’s Disease with a 6 -Year all-Participants-on Treatment Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
85EUCTR2017-003458-18-GB
(EUCTR)
19/12/201727/09/2017A clinical trial to study the effects of IRL790 in Parkinson's disease dyskinesiaA randomised, double-blind, placebo-controlled, phase IIA study evaluating the efficacy and tolerability of IRL790 in Parkinson's disease dyskinesia Parkinson's disease dyskinesia
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Integrative Research Laboratories AB (IRLAB)NULLNot Recruiting Female: yes
Male: yes
74 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03250117
(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
87EUCTR2017-001673-17-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
88EUCTR2017-000128-81-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
89EUCTR2016-003961-25-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
90NCT03272230
(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
91EUCTR2017-000128-81-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
92EUCTR2017-000087-15-AT
(EUCTR)
17/08/201718/05/2017A Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab(PRX002) in Participants with Early Parkinson's Disease with A 6-Year all-Participants-on-Treatment Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
93EUCTR2014-004865-26-GR
(EUCTR)
01/08/201725/04/201726-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88Phase 3United States;European Union;Canada;Greece;Spain;Australia;Germany;Italy;Sweden
94EUCTR2017-000087-15-FR
(EUCTR)
27/07/201730/10/2017A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2United States;France;Spain;Austria;Germany
95EUCTR2017-000087-15-ES
(EUCTR)
26/07/201708/06/2017A Study to Evaluate the Efficacy of Intravenous RO7046015 (PRX002) in Participants with Early Parkinson’s Disease with A 52-Week Blinded Extension (Pasadena)A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 52-WEEK PHASE II STUDY TO EVALUATE THE EFFICACY OF INTRAVENOUS RO7046015 (PRX002) IN PARTICIPANTS WITH EARLY PARKINSON’S DISEASE WITH A 52 WEEK BLINDED EXTENSION (PASADENA) Parkinson’s disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: aSyn Mab
Product Code: RO7046015
INN or Proposed INN: N/A
Other descriptive name: PRX002, ELT2, anti-alpha-synuclein monoclonal antibody
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 2France;United States;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96NCT03178786
(ClinicalTrials.gov)
July 18, 20175/6/2017Visual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's DiseaseVisual Spatial Exploration and Art Therapy Intervention in Patients Diagnosed With Parkinson's DiseaseParkinson DiseaseBehavioral: PAT sessionsNYU Langone HealthNULLRecruiting40 Years75 YearsAll40N/AUnited States
97EUCTR2015-005814-31-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
98NCT03185481
(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
99EUCTR2016-003961-25-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
100NCT03100149
(ClinicalTrials.gov)
June 27, 201729/3/2017A Study to Evaluate the Efficacy of Prasinezumab (RO7046015/PRX002) in Participants With Early Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, 52-Week Phase II Study to Evaluate the Efficacy of Intravenous RO7046015/Prasinezumab (PRX002) in Participants With Early Parkinson's Disease With a 6-Year All-Participants-on-Treatment ExtensionParkinson's DiseaseDrug: RO7046015;Drug: PlaceboHoffmann-La RocheProthena Biosciences LimitedActive, not recruiting40 Years80 YearsAll316Phase 2United States;Austria;France;Germany;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2015-005814-31-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
102NCT03116295
(ClinicalTrials.gov)
June 20, 201712/4/2017Bioavailability and Bioequivalence Study of Two Different Sources of OpicaponeA Comparative, Randomized, Open-label, Fasted, Single-dose, 2-way Crossover Bioavailability and Bioequivalence Study of Two Different Sources of Opicapone in Healthy SubjectsParkinson DiseaseDrug: Opicapone (OPC)Bial - Portela C S.A.NULLCompleted18 Years55 YearsAll56Phase 1Germany
103EUCTR2015-005814-31-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
104EUCTR2016-003961-25-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
105EUCTR2016-003961-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2017-000135-14-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
107EUCTR2015-005814-31-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
108NCT03065192
(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
109NCT03119636
(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
110NCT03128450
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03051607
(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
112EUCTR2016-003961-25-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
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Czech Republic;Hungary;European Union;Canada;Spain;Australia;Germany;Italy;United Kingdom
113EUCTR2016-001403-23-GR
(EUCTR)
31/03/201714/10/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;European Union;Greece;Finland;Spain
114EUCTR2016-003456-70-GB
(EUCTR)
22/03/201726/01/2017A clinical trial to compare APL-130277 sublingual film to Subcutaneous Apomorphine in Parkinson’s Disease patientsAn Open-Label, Randomized, Crossover Trial utilizing a Single-BlindedRater to evaluate APL-130277 compared to s.c. Apomorphine in LevodopaResponsive Subjects with Parkinson's Disease Complicated by MotorFluctuations Levodopa Responsive Patients with Parkinson’s Disease Complicated by Motor Fluctuations (OFF episodes)
MedDRA version: 21.1;Level: LLT;Classification code 10034006;Term: Parkinson's disease aggravated;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Trade Name: APO-go
Product Name: s.c. apomorphine
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorphine hydrochloride
Other descriptive name: APOMORPHINE HYDROCHLORIDE
Product Name: Apomorphine hydrochloride
Product Code: APL-130277
INN or Proposed INN: Apomorp
Sunovion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
106Phase 3France;Spain;Austria;Germany;Italy;United Kingdom
115EUCTR2015-003513-24-SK
(EUCTR)
14/03/201704/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited 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
116EUCTR2015-005814-31-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
210 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Belgium;Spain;Poland;Austria;Israel;Germany;Italy
117EUCTR2016-001403-23-FI
(EUCTR)
22/02/201731/08/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;European Union;Greece;Finland;Spain
118NCT02799381
(ClinicalTrials.gov)
February 9, 201710/6/2016A Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease (DYSCOVER)An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects With Advanced Parkinson's Disease DYSCOVER (DYSkinesia COmparative Interventional Trial on Duodopa VERsus Oral Medication)Parkinson's Disease (PD)Drug: Optimized antiparkinsonian treatment;Drug: Levodopa-Carbidopa Intestinal Gel (LCIG);Device: CADD-Legacy ambulatory infusion pump;Device: Percutaneous endoscopic gastrostomy tube;Device: Jejunal extension tubeAbbVieNULLCompleted30 YearsN/AAll63Phase 3United States;Finland;Greece;Hungary;Italy;Slovakia;Spain
119EUCTR2015-005814-31-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
170 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Ukraine;Austria;Russian Federation;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Germany
120EUCTR2015-004344-19-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
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Canada;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
121NCT03119194
(ClinicalTrials.gov)
January 27, 201713/4/2017Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-BIA 9-1067 in Healthy Male SubjectsParkinson DiseaseDrug: [14C]-BIA 9-1067Bial - Portela C S.A.NULLCompleted30 Years65 YearsMale7Phase 1United Kingdom
122NCT02969369
(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
123NCT02934919
(ClinicalTrials.gov)
December 201614/10/2016Evaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label StudyEvaluation of Nalmefene in Impulse Control Disorders in Parkinson's Disease: A Prospective Open Label StudyImpulse Control Disorders;Parkinson DiseaseDrug: NalmefeneUniversity Hospital, Clermont-FerrandNULLNot yet recruiting18 Years80 YearsBoth30Phase 2France
124NCT02941822
(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
125EUCTR2016-001403-23-SK
(EUCTR)
29/11/201607/09/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's disease An Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 20.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;European Union;Slovakia;Greece;Finland;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT03007888
(ClinicalTrials.gov)
November 14, 20166/12/2016A Study to Assess the PK and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseA Randomized, Multiple Dose Study to Assess the Pharmacokinetics and Pharmacodynamics of IPX203 in Subjects With Advanced Parkinson's DiseaseAdvanced Parkinson's DiseaseDrug: IR CD-LD;Drug: ER CD-LDImpax Laboratories, LLCNULLCompleted40 Years100 YearsAll28Phase 2United States
127EUCTR2016-001403-23-ES
(EUCTR)
14/11/201615/11/201612-Week study comparing Levodopa-Carbidopa Intestinal Gel / Levodopa Carbidopa Enteral Suspension to Optimized Medical Treatment on dyskinesia in subjects with advanced Parkinson's diseaseAn Open-label, Randomized 12 Week Study Comparing Efficacy of Levodopa-Carbidopa Intestinal Gel/Carbidopa-Levodopa Enteral Suspension and Optimized Medical Treatment on Dyskinesia in Subjects with Advanced Parkinson's Disease - DYSCOVER (DYSkinesia COmparative interventional trial on Duodopa VERsus oral medication) - DYSCOVER Study Dyskinesia in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3United States;European Union;Spain
128NCT03531060
(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
129NCT02871427
(ClinicalTrials.gov)
October 20, 201615/8/2016Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior DisorderAn Open-label Study of Nelotanserin in Patients With Lewy Body Dementia Who Have Frequent Visual Hallucinations or REM Sleep Behavior DisorderLewy Body Dementia;Dementia With Lewy Bodies;Parkinson's Disease Dementia;Visual Hallucinations;REM Sleep Behavior DisorderDrug: NelotanserinAxovant Sciences Ltd.NULLTerminated50 YearsN/AAll80Phase 2United States
130EUCTR2015-002571-24-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
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02935842
(ClinicalTrials.gov)
October 1, 201618/8/2016Evaluation of Intensive Language TherapyEffectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded TrialParkinson's DiseaseOther: Specific SL-therapy;Other: Rhythmic Balance-Movement Training (rBMT)University Hospital, Basel, SwitzerlandNULLCompleted45 Years80 YearsAll38N/ASwitzerland
132JPRN-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
133EUCTR2015-003513-24-DE
(EUCTR)
08/09/201615/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
134EUCTR2015-005814-31-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
135EUCTR2014-001014-25-ES
(EUCTR)
20/07/201615/07/2016Brain amyloid beta burden as per florbetaben PETBrain Amyloid-Beta burden as per florbetaben (Neuraceq) pet and cognitive outcomes after deep brain stimulation in Parkinsin's disease Parkinson's Disease
MedDRA version: 19.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Neuraceq
Product Name: Neuraceq
INN or Proposed INN: FLORBETABEN (18F)
Fundació Clínic per la Recerca BiomèdicaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT02615873
(ClinicalTrials.gov)
July 201623/11/2015A Study of AP-CD/LD in Fluctuating Parkinson's Disease Patients Who Completed IN 11 004An Open-Label,Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects Who Completed Study IN 11 004Parkinson's DiseaseDrug: Accordion Pill™ Carbidopa/LevodopaIntec Pharma Ltd.NULLUnknown status30 Years100 YearsAll460Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom
137NCT02452723
(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
138EUCTR2015-004344-19-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
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Canada;Germany;Italy;United Kingdom
139EUCTR2015-003513-24-BG
(EUCTR)
27/06/201626/04/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
140EUCTR2015-003513-24-IT
(EUCTR)
23/06/201605/11/2020OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 - OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004 Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [NA]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [NA]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
266Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141JPRN-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
142EUCTR2015-003513-24-HU
(EUCTR)
24/05/201602/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
143EUCTR2015-003513-24-ES
(EUCTR)
18/05/201618/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004 Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
460 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
144EUCTR2016-000637-43-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
145EUCTR2015-003887-34-PL
(EUCTR)
06/05/201626/02/2016A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease Moderate to severe Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT02728947
(ClinicalTrials.gov)
May 201631/3/2016Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's DiseaseA Single Group and Open-label Study to Evaluate Pharmacokinetic Profile of Neupro Patch Administrated at 2 mg, 4 mg, 6 mg and 8 mg/Day Weekly in Patients With Early-stage Parkinson's DiseaseParkinson's DiseaseDrug: ROTIGOTINELuye Pharma Group Ltd.NULLCompleted18 Years99 YearsBoth28Phase 1United States
147NCT02726386
(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
148EUCTR2015-003513-24-GB
(EUCTR)
28/04/201604/03/2016OPEN-LABEL EXTENSION and FOLLOW-UP of STUDY IN 11 004An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of AP-CD/LD in Fluctuating Parkinson's Disease Subjects who Completed Study IN 11 004
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
266 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
149EUCTR2015-003887-34-DE
(EUCTR)
12/04/201623/12/2015A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease Moderate to severe Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
150EUCTR2014-005630-60-AT
(EUCTR)
12/04/201604/12/2015A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study with an Open-Label Phase to Determine theEfficacy and Safety of Tozadenant as Adjunctive Therapy inLevodopa-Treated Patients with Parkinson’s DiseaseExperiencing End-of-Dose Wearing-Off” (TOZ-PD) - TOZ-PD Parkinson’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tozadenant
Product Code: SYN115
INN or Proposed INN: Tozadenant
Other descriptive name: TOZADENANT
Biotie Therapies Inc.(a wholly owned subsidiary of Acorda Therapeutics Inc.)NULLNot RecruitingFemale: yes
Male: yes
450Phase 3United States;Czech Republic;European Union;Canada;Spain;Austria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT03034538
(ClinicalTrials.gov)
April 8, 201625/1/2017An Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's DiseaseAn Open-Label Tolerability and Exploratory Efficacy Study of Zonisamide for Dyskinesias in Parkinson's DiseaseParkinson Disease;Parkinsonism;DyskinesiasDrug: ZonegranThe Cooper Health SystemNULLRecruiting18 YearsN/AAll20Phase 4United States
152EUCTR2015-004344-19-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
153EUCTR2015-003887-34-CZ
(EUCTR)
02/03/201630/12/2015A Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline inSubjects with Moderate to Severe Parkinson’s Disease Moderate to severe Parkinson's disease
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Product Name: KW-6002 (istradefylline)
Product Code: KW-6002
INN or Proposed INN: Istradefylline
Other descriptive name: ISTRADEFYLLINE
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;United States;Czech Republic;Canada;Poland;Israel;Germany
154JPRN-UMIN000021236
2016/03/0101/03/2016Investigation in effect of aroma therapy using magnetoencepharography Normal volunteer, Epilepsy patients, Parkinson disease patientsaroma 1
Trans-nasal administration of lavender essence
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
aroma 2
Trans-nasal administration of grapefruit essence
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
fragrant
Trans-nasal administration of fragrant
Subject hold a cup with 0.05ml essence in front of the nose for 2 minutes
After the administration, MEG signals will be recorded for 4 minutes
Also, the subjects were evaluated their moods and awareness.
Osaka University Graduate School of Medicine Department of NeurosurgeryNULLComplete: follow-up continuing20years-old80years-oldMale and Female10Phase 1Japan
155JPRN-JapicCTI-153112
22/1/201625/12/2015ONO-2370 Phase 2 study(ONO-2370-02)ONO-2370 a Phase 2 Double-Blind, Randomised, Placebo-Controlled, Parallel-Group study, and an Open-Label, Uncontrolled, Multicenter, Long-term, Extension study(ONO-2370-02) Parkinson's diseaseIntervention name : ONO-2370
INN of the intervention : Opicapone
Dosage And administration of the intervention : ONO-2370 once-daily
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Once-daily placebo equivalent to active control
ONO PHARMACEUTICAL CO.,LTD.NULLcomplete3083BOTH399Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156NCT02579473
(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
157NCT02649608
(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
158EUCTR2014-005630-60-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
159NCT02610231
(ClinicalTrials.gov)
December 201513/11/2015Long Term Study of Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseA Phase 3, Long-term, Open-label Study of Istradefylline in Subjects With Moderate to Severe Parkinson's DiseaseIdiopathic Parkinson's DiseaseDrug: Istradefylline 20 mg or 40 mgKyowa Hakko Kirin Pharma, Inc.Kyowa Kirin Co., Ltd.Completed30 YearsN/AAll239Phase 3United States;Canada;Czechia;Germany;Israel;Italy;Poland;Serbia;Czech Republic
160EUCTR2015-002631-17-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
18 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161JPRN-jRCTs041180070
04/11/201507/03/2019Trerief Impact in PD PET StudyRandomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - TIPPS Parkinson's disease
Parkinson's disease;D010300
[1] Zonisamide treatment group
Zonisamide (25 mg) once daily in addition to levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) one or two tablets per day in case of developing wearing off phenomenon, 2) change of dose and/or administration of levodopa/DCI, and 3) addition of other anti-parkinsonian drugs due to exacerbation of symptoms.
[2] Zonisamide non-treatment group
Only levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Ouchi YasuomiNULLNot RecruitingNot applicable< 80age oldBoth20N/AJapan
162NCT02914366
(ClinicalTrials.gov)
November 20158/9/2016Ambroxol as a Treatment for Parkinson's Disease DementiaAmbroxol as a Novel Disease Modifying Treatment for Parkinson's Disease DementiaParkinson's Disease DementiaDrug: Ambroxol;Other: PlaceboLawson Health Research InstituteWeston Brain Institute;University of Western Ontario, Canada;London Health Sciences CentreRecruiting50 YearsN/AAll75Phase 2Canada
163NCT02271503
(ClinicalTrials.gov)
November 201513/10/2014A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's DiseaseA Study to Assess the Pharmacokinetics and Pharmacodynamics of a Single Dose of IPX203 in Patients With Advanced Parkinson's DiseaseParkinson's DiseaseDrug: CD-LD IR;Drug: IPX203 180 mg;Drug: IPX203 270 mg;Drug: Rytary 195 mg;Drug: Rytary 145 mgImpax Laboratories, LLCNULLCompleted40 YearsN/AAll26Phase 2United States
164EUCTR2014-005630-60-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
165JPRN-UMIN000019524
2015/10/0128/10/2015Randomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) imagesRandomized, multicenter, open-label, comparative study on neuroprotective effects of zonisamide (Trerief), anti-parkinsonian drug, in patients with early Parkinson's disease: Evaluation by functional PET (positron emission tomography) images - Trerief Impact in PD PET Study (TIPPS) Parkinson's DiseaseZonisamide treatment group:

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

Only Levodopa/DCI with fixed dosage and administration.
Note that after one-year fixed protocol period, the followings are allowed; 1) change of dose and/or administration of levodopa/DCI and 2) addition of other anti-parkinsonian drugs except for zonisamide due to exacerbation of symptoms.
Hamamatsu University School of MedicineNULLComplete: follow-up completeNot applicable80years-oldMale and Female20Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2014-005630-60-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
167EUCTR2014-004865-26-IT
(EUCTR)
21/09/201529/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 18.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
88European Union;Canada;Spain;Australia;Germany;Italy;Sweden
168NCT02549092
(ClinicalTrials.gov)
September 9, 201511/9/2015A Study to Examine the Effect of Levodopa-Carbidopa Intestinal Gel (LCIG) Therapy Relative to That of Optimized Medical Treatment (OMT) on Non-motor Symptoms (NMS) Associated With Advanced Parkinson's Disease (PD)An Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) THerapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects With Advanced Parkinson's Disease - INSIGHTS StudyAdvanced Parkinson's DiseaseDrug: ABT-SLV187AbbVieNULLActive, not recruiting30 Years99 YearsAll89Phase 3United States;Australia;Canada;Germany;Greece;Italy;Korea, Republic of;Spain;Sweden
169NCT02542696
(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
170EUCTR2014-004865-26-DE
(EUCTR)
27/08/201522/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3European Union;Canada;Spain;Australia;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2014-004865-26-SE
(EUCTR)
05/08/201525/05/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease – INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease
MedDRA version: 19.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA MONOHYDRATE
AbbVie Deutschland GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
88Phase 3United States;European Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
172NCT02337751
(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
173EUCTR2014-000657-36-NL
(EUCTR)
22/06/201503/06/2015Trial to investigate the efficacy of treatments in apomorphine-induced skin reactionsOpen-label crossover trial to investigate the efficacy of treatments in apomorphine-induced skin reactions - Treatment of apomorphine-induced skin reactions: a pilot study Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]University Medical Center GroningenNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noNetherlands
174EUCTR2014-003739-20-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
175EUCTR2014-004865-26-ES
(EUCTR)
19/06/201515/06/201526-Week Study Comparing Levodopa-Carbidopa Intestinal Gel to Optimized Medical Treatment on Non-Motor Symptoms in Subjects with Advanced Parkinson's DiseaseAn Open-label, Randomized 26-Week Study Comparing Levodopa-Carbidopa INteStInal Gel (LCIG) Therapy to Optimized Medical Treatment (OMT) on Non-Motor Symptoms (NMS) in Subjects with Advanced Parkinson's Disease ? INSIGHTS Study - INSIGHTS Study Non-motor symptoms in advanced Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]AbbVie Deutschland GmbH & Co. KGNULLNot Recruiting Female: yes
Male: yes
88 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEuropean Union;Greece;Canada;Spain;Australia;Germany;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT02769793
(ClinicalTrials.gov)
June 20159/5/2016Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ONEfficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over TrialParkinson DiseaseDrug: Levodopa dispersible;Drug: LevodopaSeoul National University HospitalSMG-SNU Boramae Medical Center;Samsung Medical CenterUnknown status31 Years80 YearsAll40Phase 4Korea, Republic of
177NCT02230930
(ClinicalTrials.gov)
June 201529/8/2014Treatment of Apomorphine-induced Skin Reactions: a Pilot StudyOpen-label Crossover Trial to Investigate the Efficacy of Treatments in Apomorphine-induced Skin ReactionsParkinson's Disease;Apomorphine-induced Skin ReactionsDrug: Apomorphine 0.25% (2.5mg/ml);Device: Massage with a spiky ball;Drug: Hydrocortisone cream 1%;Drug: Subcutaneous hydrocortisone 10mgUniversity Medical Center GroningenNULLRecruiting30 YearsN/AAll20Phase 2Netherlands
178NCT02604914
(ClinicalTrials.gov)
May 20153/11/2015A Sequential Two-Part, Open-Label Study in Healthy Male and Female Subjects1) To Identify the Concentration of CD That Provides Optimal Bioavailability of a Concomitant Fixed Concentration of LD Infused SC Continuously; 2) To Compare the Bioavailability of the Optimal LD/CD Solution to That of LD/CD Intestinal GelParkinson's DiseaseDrug: ND0612;Drug: LCIGNeuroDerm Ltd.Quotient ClinicalCompleted30 Years65 YearsAll36Phase 1United Kingdom
179NCT02448914
(ClinicalTrials.gov)
May 201512/5/2015A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD PatientsA Single Centre, Two-period, Open Label, Randomised, Cross-over Study to Assess Plasma Levodopa, Carbidopa and Entacapone Concentrations After Continuous Infusion of TRIGEL or Duodopa in Patients With Advanced Parkinson´s DiseaseParkinson's DiseaseDrug: TRIGEL;Drug: DuodopaLobSor Pharmaceuticals ABTFS Trial Form SupportCompleted30 YearsN/AAll11Phase 1Sweden
180EUCTR2014-003739-20-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
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United 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
181EUCTR2014-002697-37-GB
(EUCTR)
15/04/201519/03/2015Study of Melatonin for treatment of Nocturia in PDSingle-centre open label exploratory phase IIb pilot study of exogenous oral Melatonin for the treatment of Nocturia in adults with Parkinson’s disease - Study of Melatonin for treatment of Nocturia in PD Parkinson's DiseaseNocturia
MedDRA version: 17.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.1;Level: LLT;Classification code 10034007;Term: Parkinson's disease NOS;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Circadin®
Product Name: Melatonin
Product Code: AS2
INN or Proposed INN: Melatonin
University College LondonNULLNot RecruitingFemale: yes
Male: yes
20Phase 2United Kingdom
182EUCTR2014-003739-20-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
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Spain;Austria;Germany
183NCT02359448
(ClinicalTrials.gov)
April 20154/2/2015Melatonin for Nocturia in Parkinson's DiseaseSingle-centre Open Label Exploratory Phase IIb Pilot Study of Exogenous Oral Melatonin for the Treatment of Nocturia in Adults With Parkinson's DiseaseParkinson's Disease;NocturiaDrug: MelatoninUniversity College, LondonNULLNot yet recruiting18 YearsN/ABoth20Phase 2United Kingdom
184EUCTR2014-003739-20-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
185NCT02337764
(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
186NCT02339064
(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
187JPRN-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
188ChiCTR-DDD-17010794
2014-11-082017-03-05The study on early diagnosis of Parkinson 's disease by transcranial ultrasonographythe study on early diagnosis of Parkinson 's disease by transcranial ultrasonography Parkinson's DiseaseGold Standard:Diagnosis of Parkinson disease needs to meet 3 or more: unilateral onset;resting tremor;progressive course; long term asymmetry, the most obvious symptoms is the onset side; a good response to levodopa (70% ~ 100%); levodopa induced chorea; a reaction of levodopa lasts 5 years or more; clinical course last;Index test:Laboratory apparatus
As shown in Figure 1, The ultrasound equipment, Philips IE33-BOMJH1 color Doppler ultrasonography, Model IE-ELite, with 2-4MHz phased array probe (S5-1 probe) was used for TCS to examine SN in our study.
Transcranial ultrasound study
Ultrasonography through temporal window, alon;
Department of Neurology, Fujian Institute of Geriatrics, Fujian Medical University Union HospitalNULLCompleted3684BothTarget condition:135;Difficult condition:0China
189NCT02281474
(ClinicalTrials.gov)
November 201427/10/2014Nilotinib in Cognitively Impaired Parkinson Disease Patients 001Open Label Dose Escalation of Nilotinib in Cognitively Impaired Parkinson Disease Patients With Elevated Cerebrospinal Fluid and Blood a-SynucleinParkinson's Disease;Parkinson's Disease Dementia;Diffuse Lewy Body DiseaseDrug: NilotinibGeorgetown UniversityNULLCompleted40 Years90 YearsBoth12Phase 1United States
190NCT02224664
(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
191NCT02225548
(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
192NCT02230267
(ClinicalTrials.gov)
August 201427/8/2014High-intensity Exercise and Fall Prevention Boot Camp for Parkinson's DiseaseHigh-intensity Exercise and Fall Prevention Boot Camp for Parkinson's DiseaseParkinson's DiseaseOther: High intensity exercise and balance training;Other: Usual care arm exerciseUniversity of Nevada, Las VegasNULLCompleted45 Years85 YearsBoth27Phase 2United States
193NCT02236065
(ClinicalTrials.gov)
August 20148/9/2014Combination Therapy of Cord Blood and G-CSF for Patients With Brain Injury or Neurodegenerative DisordersA Pilot Study of Combination Therapy of Allogeneic Umbilical Cord Blood and Granulocyte-colony Stimulating Factor for Patients With Brain Injury or Neurodegenerative DisordersBrain Injury;Cerebral Palsy;Amyotrophic Lateral Sclerosis;Parkinson's DiseaseProcedure: Umbilical cord blood therapy;Biological: FilgrastimMinYoung Kim, M.D.NULLCompleted19 Years75 YearsAll10N/AKorea, Republic of
194NCT02438215
(ClinicalTrials.gov)
August 20147/8/2014Study of IRX4204 for Treatment of Early Parkinson's DiseaseAn Open-Label, Single Site Study Using [123I]ß-CIT Single Photon Emission Tomography (SPECT) to Evaluate Dopamine Transporter Binding Following Treatment With IRX4204 in Early Parkinson's Disease SubjectsParkinson's DiseaseDrug: IRX4204Io TherapeuticsNULLCompleted18 YearsN/ABoth15Phase 1United States
195NCT02202551
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT02157714
(ClinicalTrials.gov)
June 20144/6/2014Multiple Ascending Dose Study of PRX002 in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of PRX002 Administered By Intravenous Infusion in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: PRX002;Other: PlaceboProthena Biosciences LimitedHoffmann-La RocheCompleted40 Years80 YearsBoth64Phase 1United States
197NCT02082249
(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
198NCT02095171
(ClinicalTrials.gov)
March 201414/3/2014Single Ascending Dose Study of PRX002 in Healthy SubjectsA Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of PRX002 Administered by Intravenous Infusion in Healthy SubjectsParkinson's DiseaseDrug: PRX002;Other: PlaceboProthena Biosciences LimitedHoffmann-La RocheCompleted21 Years65 YearsBoth40Phase 1United States
199NCT02111330
(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
200NCT01883505
(ClinicalTrials.gov)
December 20139/6/2013A Phase 2a Study Followed to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients Receiving ND0612A Phase 2a Multicentre Randomized Double Blind Placebo Controlled Study Followed by an Open Label Period, to Evaluate the Safety, Tolerability and Levodopa Pharmacokinetics in Levodopa-treated Parkinson's Disease Patients With Motor Fluctuations, Administered With Repeated Continuous Subcutaneous ND0612Parkinson's DiseaseDrug: Levodopa and carbidopa;Drug: PlaceboNeuroDerm Ltd.NULLCompleted30 YearsN/ABoth30Phase 2Israel
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201NCT02103465
(ClinicalTrials.gov)
December 201326/3/2014Possible Use of Rotigotine in Subjects 70 Years and Older With Late Onset of DiseaseLate Onset Parkinson's Disease in Subjects 70 Years and Older: Possible Use of RotigotineParkinson's DiseaseDrug: Rotigotine;Drug: PlaceboAzienda Ospedaliera Cardinale G. PanicoNULLTerminated70 YearsN/ABoth80Phase 2Italy
202NCT01973543
(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
203NCT01960842
(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
204NCT01931488
(ClinicalTrials.gov)
August 201314/8/2013124I-MIBG Tracer Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors.The Feasibility of Novel 124I-MIBG Tracer in Evaluation of Myocardial Sympathetic Denervation and Assessment of Neuroendocrine Tumors. Comparison With 123I-MIBG.Parkinson Disease;Neuroendocrine TumorsOther: MIBG label with I123 or I124;Device: SPECT imagingTel-Aviv Sourasky Medical CenterNULLRecruiting18 YearsN/ABoth40Phase 2Israel
205NCT01765257
(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
206NCT02263235
(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
207EUCTR2013-000827-15-IT
(EUCTR)
11/05/201315/03/2013LATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINELATE ONSET PARKINSON’S DISEASE IN SUBJECTS 70 YEARS AND OLDER: POSSIBLE USE OF ROTIGOTINE - PARROT Parkinson disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Rotigotine
Product Name: neurpro
Product Code: SPM962
Unità Malattie Neurodegenerative, Ospedale Cardinale Giovanni Panico, TricaseNULLNot RecruitingFemale: yes
Male: yes
Italy
208EUCTR2011-002828-41-EE
(EUCTR)
23/04/201308/02/2013A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease.A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. Advanced Parkinson's disease.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: REQUIP-MODUTAB, 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB, 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB, 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
406United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
209NCT01829867
(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
210EUCTR2011-002828-41-SK
(EUCTR)
27/03/201304/03/2013A study to test the effectiveness of varying doses of ropinirole PR while taking L-dopa in patients with late stage Parkinson's disease.A fixed dose, dose-response study of ropinirole prolonged release (PR) as adjunctive treatment to L-dopa in patients with advanced Parkinson's disease. Advanced Parkinson's disease.
MedDRA version: 16.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Requip Modutab, 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Requip Modutab, 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Requip Modutab, 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
406United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT01736176
(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
212NCT01770145
(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
213NCT01723904
(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
214NCT01796483
(ClinicalTrials.gov)
October 201213/2/2013EEG and Pharmacological Exploration of Executive Dysfunctions Induced by STN-DBS in PDExploration électroencéphalographie et Pharmacologique Des Dysfonctionnements exécutifs Induits Par la Stimulation cérébrale Profonde du Noyau Sous-thalamique Dans la Maladie de ParkinsonParkinson DiseaseDevice: Clonidine (Catapressan);Device: Placebo 90 minutes before EEGHospices Civils de LyonNULLCompleted40 Years70 YearsAll37N/AFrance
215NCT01691924
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2011-004378-27-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
217NCT01711866
(ClinicalTrials.gov)
September 201218/10/2012A Phase 4, Open-label Study to Assess the Feasibility and Efficacy on Motor and Non-motor Symptoms of Switching From Pramipexole or Ropinirole to Rotigotine Transdermal Patch in Subjects With Advanced Idiopathic Parkinson's DiseaseAn Open-Label, Multicenter, Multinational Study to Assess the Feasibility of Switching Therapy From Pramipexole or Ropinirole to the Rotigotine Transdermal System and Its Effect on Motor and Non-Motor Symptoms in Subjects With Advanced Idiopathic Parkinson's Disease Phase 4Advanced Idiopathic Parkinson's DiseaseDrug: RotigotineUCB BIOSCIENCES GmbHOtsuka Pharmaceutical Co., Ltd.Completed30 Years80 YearsAll87Phase 4United States;Korea, Republic of;Malaysia;Singapore;Taiwan
218NCT00947037
(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
219NCT02764892
(ClinicalTrials.gov)
August 201225/9/2015A Study in Healthy Male Volunteers to Investigate a New Drug for the Treatment of Parkinson's DiseaseAn Open Label Study of V81444 Using Positron Emission Tomography to Assess Occupancy of Brain Adenosine A2A Receptors & Functional & Perfusion MRI to Explore Effects on Regional Brain Activity & Perfusion in Healthy Male VolunteersParkinson's DiseaseDrug: V81444Vernalis (R&D) LtdNULLCompleted25 Years55 YearsMale6Phase 1NULL
220EUCTR2011-004378-27-DE
(EUCTR)
15/05/201224/02/2012Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced DyskinesiasAn open-label treatment study to evaluate the safety, tolerability and efficacy of AFQ056 in Parkinson’s patients with L-dopa induced dyskinesias L-dopa induced dyskinesias in patients with Parkinson’s disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
65France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221EUCTR2011-004378-27-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
222JPRN-UMIN000007896
2012/05/0107/05/2012Levodopa challenge test for Parkinson's disease and other parkinsonian syndromes Parkinson's disease and other parkinsonian syndromesThe patients are given domperidone 30 mg/day for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day lactose powder is given to the patients and levodopa (250 mg)/carbidopa (25 mg) is given on the fifth day in a double-blind manner. On fourth and fifth day, motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
The patients are given domperidone 30 mg/day (standard dose in Japan) for 3 days. When a patient is already on any anti-parkinson drugs, these drugs were withdrawn from the night before of the evaluation day. On the fourth day levodopa (250 mg)/carbidopa (25 mg) is given to the patients and lactose powder is given on the fifth day in a double-blind manner. Motor symptoms of the patients are examined using the Unified Parkinson's Disease Rating Scale motor scores by a clinician who is blind to the test drug.
Kansai Medical UniversityNULLRecruitingNot applicableNot applicableMale and Female100Not selectedJapan
223NCT01652313
(ClinicalTrials.gov)
May 201223/7/2012Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and WomenA Single Centre, Open-label, Multiple-dose Interventional Study Investigating the Pharmacokinetic Properties of Rasagiline (Lu 00-773) in Healthy Young Chinese Men and WomenParkinson's DiseaseDrug: RasagilineH. Lundbeck A/SNULLCompleted18 Years45 YearsBoth12Phase 1China
224NCT01550484
(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
225EUCTR2011-004378-27-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
226EUCTR2011-004378-27-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
227NCT01491932
(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
228NCT01519882
(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
229NCT01565395
(ClinicalTrials.gov)
March 201226/3/2012Incobotulinum Toxin A for Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Randomized Double Blind Placebo Controlled Cross-Over Study of Incobotulinum Toxin A (Xeomin®) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS)Parkinson Disease;Amyotrophic Lateral SclerosisDrug: Incobotulinum Toxin A;Drug: placeboBeth Israel Deaconess Medical CenterMerz PharmaceuticalsWithdrawn20 Years80 YearsAll0Phase 2United States
230NCT01673724
(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
231NCT01525641
(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
232NCT01515410
(ClinicalTrials.gov)
January 201211/1/2012Study in Advanced Parkinson's Disease Patients With Predictable Motor FluctuationsA Phase 2, Randomized, Open-Label, Crossover Study to Compare DM-1992, a Novel Gastric-Retentive Extended-Release Formulation of Levodopa/Carbidopa, to an Immediate-Release Carbidopa Tablet in Patients With Advanced Parkinson's Disease With Motor FluctuationsParkinson's Disease;Motor FluctuationsDrug: DM-1992;Drug: Sinemet IRDepomedNULLCompleted30 YearsN/AAll34Phase 2United States
233EUCTR2011-000056-42-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
234JPRN-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
235NCT01479127
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
236EUCTR2011-000612-26-IT
(EUCTR)
19/09/201105/03/2012Open-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARKOpen-label study on the use of Finasteride in prolonged treatment (4 years) of tics in Tourette's disease and Parkinson's disease in the pounding - FINTOURPARK Syndrome Gilles de la Tourette's disease Parkinosn Pounding
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: PROSCAR*30CPR RIV 5MG
INN or Proposed INN: Finasteride
AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
237NCT01515774
(ClinicalTrials.gov)
September 201110/1/2012Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)An Open-label, Randomized, Multi-center, Crossover Study to Observe the Effect of Once-daily Mirapex ER® and Twice-daily Mirapex ER® in Patients With Parkinson DiseaseParkinson's DiseaseDrug: Mirapex ERSeoul National University HospitalNULLRecruiting30 Years80 YearsBoth200Phase 4Korea, Republic of
238NCT01411137
(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
239EUCTR2008-005492-94-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
240NCT01856439
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241EUCTR2008-005492-94-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
242EUCTR2008-005492-94-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
243EUCTR2008-005492-94-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
244NCT01264861
(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
245NCT02169427
(ClinicalTrials.gov)
March 201124/1/2012An Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and MetabolitesAn Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labelled BIA 9-1067 and Metabolites Following a Single Dose Oral AdministrationParkinson's Disease (PD)Drug: OPCBial - Portela C S.A.NULLCompleted18 Years55 YearsMale6Phase 1Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2008-001329-33-GB
(EUCTR)
24/02/201115/03/2010Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
AbbVie IncNULLNot Recruiting Female: yes
Male: yes
275 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;New Zealand;United Kingdom
247EUCTR2010-022363-35-DE
(EUCTR)
18/02/201119/10/2010Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial.Impact of Levodopa vs. Rotigotine on stress hormones and NGF in patients with Parkinson's Disease: A randomised, placebo-controlled double-blind trial. Parkinson's disease
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Madopar LT
Product Name: Levodopa / Benserazid
Product Code: LD / BE
INN or Proposed INN: LEVODOPA
Other descriptive name: -
INN or Proposed INN: BENSERAZIDE HYDROCHLORIDE
Other descriptive name: -
Trade Name: Neupro
Product Name: Rotigotin
Product Code: RO
INN or Proposed INN: ROTIGOTINE
Other descriptive name: -
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Germany
248NCT02880033
(ClinicalTrials.gov)
February 20113/8/2016Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating LymphocytesModulation of Oxidative Stress and Apoptosis of Energy Metabolism by Deferiprone From the Circulating Lymphocytes of Patients With Parkinson's Disease or Amyotrophic Lateral SclerosisParkinson's Disease;Amyotrophic Lateral Sclerosis;Oxidative Stress;Iron OverloadDrug: deferiprone;Drug: placeboUniversity Hospital, LilleNULLCompleted18 Years80 YearsAll90N/AFrance
249NCT01244269
(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
250EUCTR2010-020109-34-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251EUCTR2010-019418-25-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
252NCT01173731
(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
253EUCTR2010-019418-25-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
254EUCTR2009-017238-39-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
255EUCTR2009-017238-39-FR
(EUCTR)
15/09/201009/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Germany;France;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2010-019418-25-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
257NCT01536574
(ClinicalTrials.gov)
September 2, 201019/1/2012Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528Parkinson DiseaseDrug: Requip PRGlaxoSmithKlineNULLCompleted30 YearsN/AAll295Phase 3China
258EUCTR2009-017238-39-BE
(EUCTR)
27/08/201014/07/2010A Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s DiseaseA Study to Compare IPX066 and Carbidopa/Levodopa/Entacapone (CLE) in Advanced Parkinson’s Disease Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 12.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Trade Name: Nacom 100
INN or Proposed INN: CARBIDOPA
Impax Laboratories, Inc., acting through its Impax Pharmaceuticals Division (Impax)NULLNot RecruitingFemale: yes
Male: yes
56Phase 3France;Belgium;Germany;Italy
259EUCTR2009-017253-35-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
260NCT01190735
(ClinicalTrials.gov)
August 201026/8/2010Caffeine for Motor Manifestations of Parkinson's DiseaseCaffeine for Motor Manifestations of Parkinson's Disease: An Open-Label Dose-Response Study.Parkinson's DiseaseDrug: Caffeine alkaloidRon PostumaCanadian Institutes of Health Research (CIHR)Completed18 YearsN/ABoth28Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2009-017182-38-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
262EUCTR2010-018650-12-FR
(EUCTR)
13/07/201006/05/2010Evaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOXEvaluation du système noradrénergique dans l’altération de la perception douloureuse chez le patient Parkinsonien - DOULOX maladie de Parkinson
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: CYMBALTA
Product Name: duloxetine
Trade Name: APOKINON
Product Name: apomorphine
Trade Name: MODOPAR
Product Name: levodopa
Trade Name: MOTILIUM
Product Name: dompéridone
CHU de ToulouseNULLNot RecruitingFemale: yes
Male: yes
Phase 3France
263EUCTR2009-017182-38-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
264EUCTR2009-017182-38-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
265EUCTR2009-017182-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266NCT01174810
(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
267EUCTR2009-017238-39-IT
(EUCTR)
21/06/201013/07/2010A Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - NDA Study to Compare IPX066 and Carbidopa / Levodopa / Entacapone (CLE) in Advanced Parkinson’s Disease - ND Idiopathic Parkinson’s Disease (paralysis agitans)
MedDRA version: 9.1;Level: LLT;Classification code 10061536
Product Name: IPX066
Product Code: IPX066-95
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-145
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-195
INN or Proposed INN: CARBIDOPA LEVODOPA
Product Name: IPX066
Product Code: IPX066-245
INN or Proposed INN: CARBIDOPA LEVODOPA
Trade Name: NACOM 100
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: COMTAN
INN or Proposed INN: Entacapone
IMPAX LABORATORIES, INC.NULLNot RecruitingFemale: yes
Male: yes
56Germany;France;Italy
268EUCTR2009-017182-38-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
269EUCTR2010-018904-94-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
270EUCTR2010-019396-29-IT
(EUCTR)
18/05/201005/03/2012Levodopa and Pramipexole dministration modalities in patients affected by parkinson desease.Levodopa Administration Modalities and Pramipexole in Parkinson's Disease (LAMP-PD study) A multicenter, randomized, four parallel groups, active-controlled, open-label study to evaluate the risk of dyskinesia in early PD. - LAMP-PD Patients with idiopathic Parkinson's Disease.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: COMTAN
INN or Proposed INN: Entacapone
INN or Proposed INN: Levodopa and decarboxylase inhibitor
Trade Name: STALEVO*100CPR 50/12,5/200MG
INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor
Trade Name: STALEVO*100CPR 100/25/200MG
INN or Proposed INN: Levodopa, decarboxylase inhibitor and COMT inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
INN or Proposed INN: Levodopa and decarboxylase inhibitor
AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO-VITTORIO EMANUELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271EUCTR2009-017182-38-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
272NCT01130493
(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
273NCT01532115
(ClinicalTrials.gov)
May 201023/1/2012Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and WomenA Randomized, Double-blind, Placebo-controlled and Open-label Active-controlled, 4-period Crossover Trial to Evaluate the Effect of BIA 9-1067 on Cardiac Repolarization in Healthy Adult Men and WomenParkinson DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: moxifloxacinBial - Portela C S.A.NULLCompleted18 Years55 YearsBoth64Phase 1France
274EUCTR2009-018137-37-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
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
275NCT01096186
(ClinicalTrials.gov)
March 201025/3/2010An Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseAn Open Label Extension Study of the Safety and Clinical Utility of IPX066 in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX066 95 mg;Drug: IPX066 145 mg;Drug: IPX066 195 mg;Drug: IPX066 245 mgImpax Laboratories, LLCNULLCompleted30 YearsN/AAll617Phase 3United States;Canada;Estonia;Germany;Latvia;Lithuania;Poland;Romania;Spain;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276NCT01066442
(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
277NCT02101190
(ClinicalTrials.gov)
March 201020/1/2012Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic ImpairmentOpen-label, Single-dose, Multi-center Study, Investigating the Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic ImpairmentParkinson's DiseaseDrug: BIA 9-1067Bial - Portela C S.A.NULLCompleted18 Years65 YearsAll16Phase 1France;Russian Federation
278EUCTR2009-014688-37-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
279EUCTR2008-005492-94-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
280EUCTR2008-001329-33-CZ
(EUCTR)
18/01/201003/12/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
INN or Proposed INN: levodopa
Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: carbidopa monohydrate
Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid
AbbVie IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
275Portugal;Czech Republic;Thailand;Poland;Australia;Russian Federation;Israel;United Kingdom;Italy;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281EUCTR2008-005492-94-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
282EUCTR2009-017416-33-DE
(EUCTR)
18/01/201021/12/2009Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol.Standardized clinical trial on the application of Levodopa (LD) / Carbidopa (CD) to patients with Parkinson disease vs LD / CD and Entacapon (EN) vs LD / CD and Tolcapon (TO) concerning the parameters motor function, pharmacokinetics of LD, plasma level of homocystein and serum level of cortisol. Male and female patients with Parkinson´s disease meeting UKPDS criteria
MedDRA version: 12.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Trade Name: Tasmar
Product Name: Tolcapon
Product Code: TO
INN or Proposed INN: TOLCAPONE
Trade Name: Comtess
Product Name: Entacapon
Product Code: EN
INN or Proposed INN: ENTACAPONE
Trade Name: Isicom
Product Name: Levodopa/Carbidopa
Product Code: LD/CD
INN or Proposed INN: LEVODOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Clinical research lab for neurodegeneration, Dept. of Neurology, St. Josef-Hospital, Ruhr-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
283EUCTR2009-014688-37-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
284EUCTR2009-011541-24-NL
(EUCTR)
30/12/200929/05/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
285EUCTR2009-014688-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2008-005492-94-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
1285 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Estonia;Slovakia;Finland;Spain;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Bulgaria;Germany;Netherlands
287EUCTR2009-014688-37-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
288NCT01036139
(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
289NCT01032486
(ClinicalTrials.gov)
December 200911/12/2009Study for Rasagiline Effect on Sleep Trial(REST)in Parkinson's DiseaseAn Open-Label, Multi-Center, Single Arm Study to Evaluate the Effects of Azilect® on Sleep Disturbances in Parkinson's Disease SubjectsParkinson's DiseaseDrug: Rasagiline mesylateTeva Pharmaceutical IndustriesNULLCompletedN/AN/ABoth120Canada
290EUCTR2009-013886-24-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
246Germany;Czech Republic;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2008-005492-94-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
292EUCTR2008-005492-94-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
293EUCTR2009-013885-14-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
246France;Spain
294NCT00660673
(ClinicalTrials.gov)
November 13, 200915/4/2008Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced PDOpen-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous StudiesAdvanced Parkinson's DiseaseDrug: Levodopa-carbidopa intestinal gel;Device: CADD-Legacy® 1400 ambulatory infusion pumpAbbVie (prior sponsor, Abbott)Quintiles, Inc.Active, not recruiting30 Years99 YearsAll262Phase 3United States;Australia;Canada;Czechia;Israel;New Zealand;Poland;Portugal;Russian Federation;Thailand;United Kingdom;Czech Republic
295EUCTR2009-013885-14-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
296EUCTR2008-005492-94-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
297EUCTR2008-005492-94-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
298EUCTR2009-011541-24-GB
(EUCTR)
09/10/200929/05/2009A trial to follow-up subjects with Parkinson's disease who participated to the ADAGIO study in order to study the long-term effects of the drug rasagilineAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 13.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Argentina;Romania;Germany;Netherlands
299EUCTR2008-005492-94-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
300EUCTR2008-001329-33-PT
(EUCTR)
02/10/200919/08/2009Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's DiseaseOpen-Label Continuation Treatment Study With Levodopa – Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies. Treatment with Levodopa – Carbidopa Intestinal Gel in subjects with advanced Parkinson's disease and severe motor-fluctuations who have exhibited a persistent and positive effect to treatment in previous studies
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Duodopa, 20 mg/ml + 5 mg/ml, intestinal gel
INN or Proposed INN: levodopa
Other descriptive name: Ph. Eur.: (2S)-2-amino-3-(3,4-dihydroxyphenyl)propanoic acid
INN or Proposed INN: carbidopa monohydrate
Other descriptive name: Ph. Eur.: (2S)-3-(3,4-dihydroxyphenyl)-2hydrazino-2methylprop acid
AbbVie IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
275Portugal;Czech Republic;Thailand;Poland;Australia;Israel;Russian Federation;Italy;United Kingdom;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
301EUCTR2008-005492-94-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
302NCT01631825
(ClinicalTrials.gov)
October 200925/6/2012A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease PatientsAn Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopaParkinson's DiseaseDrug: SPM 962Otsuka Pharmaceutical Co., Ltd.NULLCompletedN/AN/AAll321Phase 3Japan
303EUCTR2006-005186-18-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
304EUCTR2009-011541-24-DE
(EUCTR)
22/09/200927/07/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
700Portugal;France;Hungary;Spain;Netherlands;Germany;Italy;United Kingdom
305NCT01371682
(ClinicalTrials.gov)
September 18, 200910/6/2010A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and ArandaAn Open Label Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets (Ropinirole XL, Marketed as REQUIP-MODUTAB™, REQUIP XL™ at 2 mg) Manufactured at Crawley and ArandaParkinson DiseaseDrug: Ropinirole XLGlaxoSmithKlineNULLCompleted18 Years50 YearsAll50Phase 1Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
306EUCTR2009-011541-24-PT
(EUCTR)
09/09/200929/07/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: AZILECT
INN or Proposed INN: Rasagiline
Other descriptive name: Rasagiline mesylate
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
700France;Portugal;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
307NCT00974974
(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
308NCT00986245
(ClinicalTrials.gov)
September 200924/9/2009Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-dailyAn Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson DiseaseParkinson DiseaseDrug: Ropinirole Prolonged releaseSeoul National University HospitalNULLCompleted30 Years80 YearsAll82Phase 4Korea, Republic of
309EUCTR2009-011541-24-ES
(EUCTR)
27/08/200926/06/2009 An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study. Estudio de seguimiento, multicéntrico, abierto diseñado para evaluar los efectos a largo plazo de Rasagilina en pacientes con enfermedad de Parkinson que participaron en el estudio ADAGIO - ADAGIO Follow-Up Parkinson's Disease Enfermedad de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
310EUCTR2009-011736-35-FR
(EUCTR)
27/07/200906/08/2009Etude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYSEtude pilote de phase II, N=1 en crossover répétés, en double aveugle, randomiséeversus placebo, multicentrique, évaluant l’efficacité de la SIMVAstatine sur lesDYSkinésies induites par la L-Dopa chez des patients atteints de maladie de Parkinson - SIMVADYS Maladie de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: LODALÈS®
Product Code: simvastatine
CHU de BordeauxNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
10Phase 2France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
311EUCTR2009-011541-24-FR
(EUCTR)
17/07/200919/06/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
312EUCTR2009-011541-24-HU
(EUCTR)
10/07/200905/06/2009An Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-UpAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects who Participated in the ADAGIO Study - ADAGIO Follow-Up Parkinson's Disease
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Teva Pharmaceutical Industries LtdNULLNot Recruiting Female: yes
Male: yes
700 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;France;Hungary;Spain;Germany;Netherlands;Italy;United Kingdom
313NCT00936676
(ClinicalTrials.gov)
July 20098/7/2009ADAGIO Follow Up Study: Evaluation of the Long-Term Effects of Rasagiline in Parkinson's Disease SubjectsAn Open-Label, Multi-Center, Follow-Up Study Designed to Evaluate the Long-Term Effects of Rasagiline in Parkinson's Disease Subjects Who Participated in the ADAGIO StudyParkinson's DiseaseDrug: rasagiline mesylateTeva Pharmaceutical IndustriesTeva Neuroscience, Inc.;H. Lundbeck A/SCompletedN/AN/ABoth684N/AUnited States;Argentina;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Portugal;Romania;Spain;United Kingdom
314EUCTR2008-004146-88-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
315EUCTR2009-010193-38-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
316EUCTR2009-010193-38-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
317NCT00360568
(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
318EUCTR2006-000578-53-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
319EUCTR2009-010193-38-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
320NCT01515891
(ClinicalTrials.gov)
May 200919/1/2012Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and MetabolitesAn Open-label Study in Healthy Male Subjects to Assess the Absorption, Distribution, Metabolism and Excretion of [14C]-Labeled BIA 9-1067 and Metabolites Following a Single-dose Oral AdministrationParkinson DiseaseDrug: BIA 9-1067Bial - Portela C S.A.NULLCompleted40 Years55 YearsMale4Phase 1Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
321EUCTR2008-005492-94-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
322EUCTR2008-008210-38-FR
(EUCTR)
16/04/200919/03/2009Effet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-IEffet d’un traitement anti-glutamatergique sur les troubles de la marche avec freezing et sur l’attention dans la maladie de Parkinson: freezing of gait and glutamate: FOGG-I” - FOGG-I Patients ayant une maladie de Parkinson Patients à un stade évolué de la maladie avec des troubles de la marche sévères
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
MedDRA version: 9.1;Level: PT;Term: Parkinson's disease
Trade Name: EBIXA®
Product Name: mémantine
Trade Name: L-Dopa/ MODOPAR
Product Name: L-Dopa
Chru de LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
28France
323EUCTR2007-004234-16-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
324EUCTR2007-004235-37-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
325NCT00880620
(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
326NCT00865579
(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
327EUCTR2007-003035-22-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
328EUCTR2006-005186-18-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
329EUCTR2007-003035-22-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
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
330EUCTR2007-003035-22-IT
(EUCTR)
07/01/200923/07/2008A Multi-Center, Open-Label Extension Study to Examine the Safety and Tolerability of ACP-103 in the Treatment of Psychosis in Parkinson's Disease - ACP-103-015 Psychosis in Parkinson?s Disease
MedDRA version: 9.1;Level: LLT;Classification code 10037241;Term: Psychosis NOS
Product Name: primavanserin tartrate
Product Code: ACP-103
INN or Proposed INN: primavanserin tartrate
ACADIA PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
486Portugal;United Kingdom;Belgium;France;Italy;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
331EUCTR2008-004906-15-FR
(EUCTR)
05/01/200916/03/2009EVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de ParkinsonEVALUATION DE LA CAPTATION D’UN RADIOLIGAND DES TRANSPORTEURS DE LA DOPAMINE CHEZ DES SUJETS ATTEINTS DE LA MALADIE DE PARKINSON ET PRESENTANT OU NON DES DOULEURS EN RAPPORT AVEC CETTE PATHOLOGIE - dénervation dopaminergique et douleur dans la maladie de Parkinson Maladie de Parkinson
MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's
Trade Name: DATSCANCHU ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
332EUCTR2004-000148-26-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
333EUCTR2006-005186-18-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
320 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Finland;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Poland;Australia;Netherlands;Germany;New Zealand
334EUCTR2007-006721-27-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
335EUCTR2007-003035-22-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
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Ukraine;Austria;Russian Federation;United Kingdom;Italy;India;France;European Union;Canada;Belgium;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
336NCT00869791
(ClinicalTrials.gov)
November 200824/3/2009A Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaA Study to Compare Pharmacokinetics and Pharmacodynamics of IPX066 to Standard Carbidopa-LevodopaParkinson's DiseaseDrug: IPX066;Drug: IR CD-LDImpax Laboratories, LLCNULLCompleted30 YearsN/AAll27Phase 2United States
337EUCTR2007-006721-27-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
338EUCTR2007-000350-31-IT
(EUCTR)
02/10/200811/02/2008A 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - NDA 76-week prospective, open-label, multicenter study to evaluate the long-term effect of Exelon capsule and transdermal patch on worsening of the underlying motor symptoms of PD in patients with mild to moderately severe dementia associated with Parkinson?s disease (PDD) - ND mild to moderately severe dementia associated with Parkinson?s disease (PDD)
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Exelon path transdermal
Product Code: ENA713B
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Trade Name: EXELON
INN or Proposed INN: Rivastigmine
Product Name: Exelon path transdermal
Product Code: ENA713B
INN or Proposed INN: Rivastigmine
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
550France;Spain;Italy
339EUCTR2007-004235-37-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
340EUCTR2006-005186-18-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
341EUCTR2007-003035-22-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
342NCT00755027
(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
343EUCTR2007-004235-37-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: