6. パーキンソン病 Parkinson disease Clinical trials / Disease details


臨床試験数 : 2,298 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202

  
166 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04952194
(ClinicalTrials.gov)
January 1, 20223/6/2021Clinical Study of Stalevo in the Treatment of Early Parkinson's DiseaseClinical Study of Stalevo in the Treatment of Early Parkinson's DiseaseParkinson DiseaseDrug: Stalevo;Drug: Carbidopa and Levodopa Controlled Release TabletsSecond Affiliated Hospital, School of Medicine, Zhejiang UniversityNULLNot yet recruiting30 Years70 YearsAll180Phase 4NULL
2NCT05128175
(ClinicalTrials.gov)
October 29, 202127/10/2021Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed ConditionsAn Open-label, Balanced, Randomized, Five-treatment, Five-period, Five-sequence, Multiple Oral Dose, Crossover Comparative Bioavailability Study of Different Strengths of Carbidopa/Levodopa Extended-release Tablets With Carbidopa and Levodopa Tablets in Normal, Healthy Adult Human Subjects Under Fasting and Fed ConditionsParkinson DiseaseDrug: WD-1603 Carbidopa-Levodopa Extended-Release TabletsShanghai WD Pharmaceutical Co., Ltd.NULLRecruiting18 Years45 YearsAll15Phase 1India
3NCT05036473
(ClinicalTrials.gov)
October 12, 202110/8/2021A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's DiseaseA Phase II Randomized, Parallel, Double-blind, Placebo-controlled, Multi-center Clinical Trial of the Efficacy and Safety of WD-1603 Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's DiseaseParkinson DiseaseDrug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets;Drug: PlaceboShanghai WD Pharmaceutical Co., Ltd.NULLRecruiting30 Years75 YearsAll40Phase 2China
4NCT04387773
(ClinicalTrials.gov)
November 5, 202011/5/2020Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's DiseaseEffect of GOCOVRI on Quantity and Quality of Gait in Parkinson's DiseaseParkinson DiseaseDrug: GOCOVRIOregon Health and Science UniversityAdamas Pharmaceuticals, Inc.Recruiting50 Years80 YearsAll12Phase 4United States
5NCT04591535
(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
6ChiCTR2000035564
2020-08-172020-08-13Pharmacokinetics and Bioequivalence study of Pramipexole Extended-Release Tablets in Healthy Chinese VolunteersPharmacokinetics and Bioequivalence study of Pramipexole Extended-Release Tablets in Healthy Chinese Volunteers Parkinson’s diseasefasting administration group-TR:phase I: Pramipexole Extended-Release Tablets; phase II: Reference preparation;fasting administration group-RT:phase I: Reference preparation: pahse II: Test preparation;high-fat postprandial administration group-TR:phase I: Pramipexole Extended-Release Tablets; phase II: Reference preparation;high-fat postprandial administration group-RT:phase I: Pramipexole Extended-Release Tablets; phase II: Reference preparation;West China Hospital of Sichuan UniversityNULLRecruiting1865Bothfasting administration group-TR:28;fasting administration group-RT:28;high-fat postprandial administration group-TR:28;high-fat postprandial administration group-RT:28;Phase 1China
7NCT04513340
(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
8NCT04275492
(ClinicalTrials.gov)
July 24, 202018/11/2019Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release TabletsStudy on Bioequivalence of Pramipexole Dihydrochloride Sustained Release TabletsParkinson's DiseaseDrug: Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride);Drug: Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)First Affiliated Hospital of Zhejiang UniversityHongguan biological pharmaceutical co.Recruiting18 Years45 YearsAll60N/AChina
9NCT04384666
(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
10NCT04571164
(ClinicalTrials.gov)
May 11, 202021/9/2020A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDA Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PDParkinson DiseaseDrug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheresLuye Pharma Group Ltd.ParexelRecruiting30 YearsN/AAll294Phase 3China
11EUCTR2018-002233-37-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, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy
12NCT04232969
(ClinicalTrials.gov)
January 20, 202010/1/2020Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's DiseaseA Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's DiseaseParkinson's DiseaseDrug: Exenatide extended release 2mg (Bydureon)University College, LondonNULLRecruiting25 Years80 YearsAll200Phase 3United Kingdom
13EUCTR2019-000732-26-SE
(EUCTR)
23/10/201907/05/2019Exenatide Treatment in Parkinson's DiseaseEffect of Exenatide on disease progression in early Parkinson's disease. Parkinson's disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Bydureon 2 mg powder and solvent for prolonged-release suspension
Product Name: BYDUREON
INN or Proposed INN: EXENATIDE
Stockholm Health Care ServicesNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Sweden
14EUCTR2018-002233-37-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
15EUCTR2018-002233-37-IT
(EUCTR)
03/05/201907/01/2021Evaluate 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. - NA 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 3France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy
16EUCTR2018-002233-37-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, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy
17EUCTR2018-002233-37-CZ
(EUCTR)
18/03/201911/12/2018Evaluate 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, LLCNULLNot RecruitingFemale: yes
Male: yes
510Phase 3United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy
18NCT03670953
(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, LLCNULLCompleted40 YearsN/AAll631Phase 3United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom
19EUCTR2018-001209-95-IT
(EUCTR)
05/07/201803/08/2021An open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s diseaseAn open-label Phase 2 study to assess the pharmacokinetics of Accordion Pill¿ Carbidopa-Levodopa compared to immediate release carbidopa-levodopa in patients with Parkinson¿s disease - IN 18001 Parkinson's Disease (PD)
MedDRA version: 20.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Accordion Pill¿ Carbidopa/levodopa
Product Code: N.A.
INN or Proposed INN: LEVODOPA
Other descriptive name: LEVODOPA
INN or Proposed INN: CARBIDOPA
Other descriptive name: CARBIDOPA
Trade Name: SINEMET - 100 MG + 25 MG COMPRESSE 50 COMPRESSE DIVISIBILI
Product Name: Sinemet
Product Code: N.A.
INN or Proposed INN: LEVODOPA
Other descriptive name: Levodopa
INN or Proposed INN: CARBIDOPA
Other descriptive name: CARBIDOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Spain;Italy
20NCT03521635
(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
21NCT03576638
(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
22EUCTR2017-001420-21-DE
(EUCTR)
18/06/201816/02/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3France;United States;Canada;Spain;Germany
23EUCTR2017-001420-21-ES
(EUCTR)
13/06/201815/03/2018Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's DiseaseA Phase 3, Twelve-week, Multi-Center, Multinational, Randomized, Double-Blind, Double-Dummy, Parallel Group Study to Determine the Efficacy, Safety and Tolerability of P2B001 Once Daily Compared to its Individual Components in Subjects With Early Parkinson’s Disease and to a Calibration Arm of Pramipexole ER. Early Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: P2B001
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Product Name: Pramipexole dihydrochloride
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Product Name: Rasagiline
INN or Proposed INN: Rasagiline mesylate
Other descriptive name: RASAGILINE MESILATE
Trade Name: Pramipexole dihydrochloride extended-release tablets
Product Name: Pramipexole dihydrochloride extended-release tablets
INN or Proposed INN: PRAMIPEXOLE DIHYDROCHLORIDE
Other descriptive name: PRAMIPEXOLE DIHYDROCHLORIDE
Pharma Two B LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
525Phase 3United States;France;Canada;Spain;Germany
24NCT03250117
(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
25NCT04045678
(ClinicalTrials.gov)
October 10, 201730/7/2019A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll30Phase 1China
26EUCTR2015-004344-19-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]
Product Name: Deferiprone 600 mg delayed release tablet
INN or Proposed INN: DEFERIPRONE
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
27NCT02728843
(ClinicalTrials.gov)
October 12, 201631/3/2016Study of Parkinson's Early Stage With DeferiproneA Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's DiseaseParkinson's DiseaseDrug: Deferiprone;Drug: PlaceboApoPharmaNULLCompleted18 Years80 YearsAll140Phase 2Canada;France;Germany;United Kingdom
28NCT02601586
(ClinicalTrials.gov)
September 201617/8/2015Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's DiseaseEvaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA TrialParkinson DiseaseDrug: PR Oxycodone;Drug: Levodopa;Drug: Oxycodone Placebo;Drug: Levodopa placeboUniversity Hospital, ToulouseNULLCompleted40 Years75 YearsAll67Phase 2/Phase 3France
29NCT02789592
(ClinicalTrials.gov)
July 201631/5/2016Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson DiseaseA Randomized Double-Blind, Double-Dummy, Crossover Study to Evaluate the Efficacy and Safety of Prolonged-Release Melatonin and Clonazepam in Patients With Rapid Eye Movement (REM) Sleep Behavior Disorder in Parkinson DiseaseREM Sleep Behavior Disorder;Parkinson DiseaseDrug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placeboSeoul National University HospitalKuhnil Pharmaceutical Co., Ltd.Not yet recruiting30 YearsN/ABoth30Phase 2Korea, Republic of
30EUCTR2015-004344-19-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]
Product Name: Deferiprone 600 mg delayed release tablet
INN or Proposed INN: DEFERIPRONE
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
31EUCTR2015-003512-20-PL
(EUCTR)
22/06/201601/04/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom
32EUCTR2015-003512-20-IT
(EUCTR)
08/06/201605/11/2020Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill¿ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson¿s Disease Patients - Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852
MedDRA version: 20.0;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/400 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
Product Name: Accordion Pill ¿ Carbidopa/Levodopa 50/500 mg
Product Code: [na]
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: LEVODOPA
INTEC PHARMA LTDNULLNot RecruitingFemale: yes
Male: yes
420Phase 3United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy
33EUCTR2015-003512-20-ES
(EUCTR)
18/05/201618/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill? Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson?s Disease Patients Parkinson's Disease
MedDRA version: 18.1;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill? Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
34EUCTR2015-003512-20-HU
(EUCTR)
09/05/201602/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 19.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
Intec Pharma, Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom
35EUCTR2015-003512-20-GB
(EUCTR)
28/04/201603/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/500 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420 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
36EUCTR2015-003512-20-SK
(EUCTR)
22/04/201604/03/2016Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s DiseaseA Phase III, Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy and Safety of Gastric Retentive, Controlled Release Accordion Pill™ Carbidopa/Levodopa (AP-CD/LD) to Immediate Release CD/LD in Fluctuating Parkinson’s Disease Patients Parkinson's Disease
MedDRA version: 20.0;Level: HLT;Classification code 10034005;Term: Parkinson's disease and parkinsonism;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SINEMET 25-100
Product Name: Immediate Release carbidopa/levodopa 25/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Trade Name: SINEMET 10-100
Product Name: Immediate Release carbidopa/levodopa 10/100 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Product Name: Accordion Pill™ Carbidopa/Levodopa 50/400 mg
INN or Proposed INN: Carbidopa
Other descriptive name: CARBIDOPA
INN or Proposed INN: Levodopa
Other descriptive name: LEVODOPA
Intec Pharma, Ltd.NULLNot Recruiting Female: yes
Male: yes
420 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
37EUCTR2015-004344-19-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
38EUCTR2015-001523-24-FR
(EUCTR)
25/03/201620/04/2016Evaluation of the pain relief of prolonged-release oxycodone and of L-Dopa, versus placebo, in Parkinson's disease.Evaluation of the analgesic effects of prolonged-release oxycodone and of L-Dopa, versus placebo, on central neuropathic pain in Parkinson's disease : OXYDOPA trial - OXYDOPA Central neuropathic pain in Parkinson's disease
MedDRA version: 19.0;Level: LLT;Classification code 10054095;Term: Neuropathic pain;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: oxycontin LP 5mg
Product Name: Oxycontin LP 5mg
INN or Proposed INN: oxycodone
Other descriptive name: OXYCODONE HYDROCHLORIDE
Trade Name: oxycontin LP 10mg
Product Name: Oxycontin LP 10mg
INN or Proposed INN: oxycodone
Other descriptive name: OXYCODONE HYDROCHLORIDE
Trade Name: oxycontin LP 20mg
Product Name: Oxycontin LP 20mg
INN or Proposed INN: oxycodone
Other descriptive name: OXYCODONE HYDROCHLORIDE
Trade Name: Modopar 125
Product Name: Modopar 125
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
INN or Proposed INN: BENSERAZIDE
Trade Name: Modopar 62,5
Product Name: Modopar 62,5
INN or Proposed INN: levodopa
Other descriptive name: LEVODOPA
UHToulouseNULLNot RecruitingFemale: yes
Male: yes
75Phase 2;Phase 3France
39NCT02605434
(ClinicalTrials.gov)
March 20165/11/2015A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's PatientsPhase 3 Multicenter Randomized Double-Blind, Double-dummy, Active-Controlled Study Comparing Efficacy/Safety of Gastric-retentive, Controlled-release Accordion Pill Carbidopa/Levodopa to Immediate Release in Fluctuating Parkinson's PatientsParkinson's DiseaseDrug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- SinemetIntec Pharma Ltd.NULLUnknown status30 YearsN/AAll420Phase 3United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary
40EUCTR2015-002631-17-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]Trade Name: Duodopa
Product Name: Duodopa
Trade Name: Sinemet Plus
Product Name: Sinemet Plus
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
41EUCTR2014-003738-24-AT
(EUCTR)
26/06/201501/04/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 17.1;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3Germany;Spain;Austria;United States
42EUCTR2014-003739-20-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
43EUCTR2014-003738-24-DE
(EUCTR)
23/04/201521/01/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
44EUCTR2014-003739-20-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]
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 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
45JPRN-JapicCTI-152870
11/4/201514/04/2015A parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPAA phase III parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA Parkinson's diseaseIntervention name : HP-3000 (ropinirole hydrochloride patch)
Dosage And administration of the intervention : Transdermal, once daily
Control intervention name : HP-3000 placebo
Dosage And administration of the control intervention : Transdermal, once daily
Control intervention name : Ropinirole hydrochloride extended-release tablet
Dosage And administration of the control intervention : Oral, once daily
Control intervention name : Ropinirole hydrochloride extended-release tablet placebo
Dosage And administration of the control intervention : Oral, once daily
Hisamitsu Pharmaceutical Co.,Inc.NULL2079BOTHPhase 3NULL
46EUCTR2014-003739-20-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]
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 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
47EUCTR2014-003739-20-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
48EUCTR2014-003738-24-ES
(EUCTR)
24/03/201516/02/2015A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's diseaseADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients with Levodopa-Induced Dyskinesia - EASE LID 3 STUDY Treatment of levodopa-induced dyskinesia in subjects with Parkinson's disease
MedDRA version: 18.0;Level: PT;Classification code 10013916;Term: Dyskinesia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release Capsule
Product Code: ADS-5102
INN or Proposed INN: Amantadine hydrochloride (HCl)
Other descriptive name: AMANTADINE HYDROCHLORIDE
Adamas Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
72Phase 3United States;Spain;Austria;Germany
49EUCTR2014-001132-10-FR
(EUCTR)
18/11/201418/06/2015A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson’s Disease Patients with Abnormal Involuntary Movements caused by LevodopaA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias Parkinson’s Disease Subjects with Levodopa-Induced Dyskinesias
MedDRA version: 18.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
162United States;France;Canada;Spain;Germany
50EUCTR2014-000335-17-GB
(EUCTR)
28/10/201423/07/2014Rotigotine and memory in Parkinson's.The Effect of Rotigotine on Memory in Idiopathic Parkinson's Disease without Cognitive Impairment - Rotigotine and Memory in Parkinson's. Idiopathic Parkinson's Disease;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: rotigotine
INN or Proposed INN: Rotigotine
Product Name: levodopa CR (controlled release)
INN or Proposed INN: levodopa
Product Name: Rasagiline
INN or Proposed INN: Rasagiline
Product Name: Selegiline
INN or Proposed INN: selegiline
Research and Development University Hospital of North StaffordshireKeele UniversityNot RecruitingFemale: yes
Male: yes
0United Kingdom
51EUCTR2014-001132-10-ES
(EUCTR)
23/10/201402/09/2014A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by LevodopaA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Germany
52EUCTR2014-001131-36-ES
(EUCTR)
23/10/201403/09/2014A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by LevodopaA Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias Parkinson's Disease Subjects with Levodopa-Induced Dyskinesias
MedDRA version: 17.0;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Product Name: Amantadine HCl Extended Release
INN or Proposed INN: Amantadine hydrochloride
Other descriptive name: AMANTADINE HYDROCHLORIDE
Osmotica Pharmaceutical Corp.NULLNot RecruitingFemale: yes
Male: yes
162Phase 3France;United States;Canada;Spain;Germany
53NCT02274766
(ClinicalTrials.gov)
October 201422/10/2014Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced DyskinesiaADS-5102 (Amantadine HCl) Extended Release Efficacy and Safety Study in Parkinson's Disease Patients With Levodopa-Induced Dyskinesia (EASE LID 3 Study)Dyskinesia;Levodopa-Induced Dyskinesia (LID);Parkinson's Disease (PD)Drug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll77Phase 3United States;Austria;France;Germany;Spain
54ChiCTR-TRC-14005143
2014-08-252014-08-14A traditional chinese medicine clinical intervention study of depressed Parkinson's disease - based on the Wenyang Jieyu methodA traditional chinese medicine clinical intervention study of depressed Parkinson's disease - based on the Wenyang Yieyu method Depressed Parkinson's diseaseChinese Medicines:Formula granule;Western Medicine group:Venlafaxine hydrochloride sustained-release capsules ;The Third Affiliated Hospital of Beijing University of Traditional Chinese MedicineNULLRecruiting5575BothChinese Medicines:60;Western Medicine group:60;2 (Phase 2 study)China
55NCT02153645
(ClinicalTrials.gov)
August 18, 201430/5/2014Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.A Multicenter, Randomized, Placebo-controlled, Double-blind, 16 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesias (LID)Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tabletsAdamas Pharmaceuticals, Inc.NULLTerminated30 Years85 YearsAll87Phase 3United States;Canada;France;Germany;Spain
56NCT02153632
(ClinicalTrials.gov)
July 30, 201430/5/2014Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LIDA Multicenter, Randomized, Placebo-controlled, Double-blind, 26 Week Study to Evaluate the Efficacy and Safety of Amantadine HCl Extended Release Tablets in Parkinson's Disease Subjects With Levodopa-Induced DyskinesiasParkinson's Disease;Levodopa Induced Dyskinesia (LID)Drug: amantadine HCl ER;Drug: PlaceboAdamas Pharmaceuticals, Inc.NULLTerminated30 Years85 YearsAll135Phase 3United States;Canada;France;Germany;Spain
57NCT02202551
(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
58NCT02136914
(ClinicalTrials.gov)
May 20149/5/2014ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)Efficacy and Safety of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia in Parkinson's Disease Patients (EASE LID Study)Dyskinesia;Levodopa Induced Dyskinesia (LID);Parkinson's DiseaseDrug: ADS-5102;Other: PlaceboAdamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll126Phase 3United States;Canada
59NCT04044547
(ClinicalTrials.gov)
November 22, 201330/7/2019A Study of LY03003 in Patients With Early-stage Parkinson's DiseaseA Randomized, Double-blinded, Multiple Ascending Dose Study in Patients With Early-stage Parkinson's Disease to Evaluate the Pharmacokinetics and Safety of LY03003 Following Intramuscular InjectionsParkinson DiseaseDrug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheresLuye Pharma Group Ltd.Beijing Bozhiyin T&S Co., Ltd.Completed18 Years75 YearsAll60Phase 1NULL
60EUCTR2011-002827-17-SK
(EUCTR)
17/09/201304/03/2013A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. Early stage Parkinson's Disease.
MedDRA version: 15.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Local Trade Name, 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Local Trade Name, 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: Local Trade Name, 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
61NCT01929317
(ClinicalTrials.gov)
August 28, 201322/8/2013A Study to Evaluate the Efficacy of 18 to 24mg/Day Ropinirole Controlled Release (CR) Tablets in Early and Advanced Parkinson's Disease (PD) Patients.A Study ROP116991, Clinical Evaluation of 18 to 24mg/Day Ropinirole CR for Parkinson's Disease.Parkinson DiseaseDrug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tabletGlaxoSmithKlineNULLTerminated20 YearsN/AAll81Phase 3Japan
62EUCTR2011-002827-17-EE
(EUCTR)
23/04/201308/02/2013A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease.A fixed dose, dose response study for ropinirole prolonged release (PR) in patients with early stage Parkinson’s Disease. Early stage Parkinson's Disease.
MedDRA version: 14.1;Level: PT;Classification code 10061536;Term: Parkinson's disease;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: REQUIP-MODUTAB , 2mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB , 4mg
Product Name: ropinirole PR, 2mg
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
Trade Name: REQUIP-MODUTAB , 8mg
Product Name: ropinirole PR
Product Code: SK&F101468
INN or Proposed INN: ROPINIROLE
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
210United States;Estonia;Slovakia;Russian Federation;Korea, Republic of
63EUCTR2011-002828-41-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
64EUCTR2011-002828-41-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
65NCT01736176
(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
66EUCTR2012-000801-64-GB
(EUCTR)
09/02/201326/11/2012A study of the effects of medication on memory in Parkinson's DiseaseA Phase IV Acceptability and Feasibility Trial of the Effects of Medication on Memory in Idiopathic Nondementing Parkinson’s Disease. - Medication and Memory in Parkinson’s Disease (MeMory PaD) Idiopathic Parkinson's Disease
MedDRA version: 17.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mirapexin extended release various strengths
Product Name: Pramipexole dihydrochloride monohydrate extended release
Product Code: N/A
INN or Proposed INN: pramipexole dihydrochloride monohydrate
Other descriptive name: Mirapexin
Trade Name: Requip prolonged release
Product Name: Ropinirole hydrochloride prolonged release
INN or Proposed INN: Ropinirole (as hydrochloride)
Other descriptive name: Requip XL prolonged-release
University Hospital of North StaffordshireKeele UniversityNot RecruitingFemale: yes
Male: yes
55Phase 4United Kingdom
67EUCTR2011-004803-19-FI
(EUCTR)
16/08/201216/05/2012PET study in PD patientsA Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Product Name: AZD3241 Extended release tablets 100 mg
Product Code: AZD3241
Product Name: [11C]PBR28
Product Code: [11C]PBR28
Product Name: [18F]FE-PE2I
Product Code: [18F]FE-PE2I
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Finland;Sweden
68EUCTR2011-002074-23-AT
(EUCTR)
05/06/201207/05/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
69NCT01494532
(ClinicalTrials.gov)
April 2, 20121/12/2011A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced Parkinson's DiseaseA Fixed Dose, Dose-response Study of Ropinirole Prolonged Release (PR) as Adjunctive Treatment to L-dopa in Patients With Advanced Parkinson's DiseaseParkinson DiseaseDrug: ropinirole/L-dopa;Drug: placebo/L-dopaGlaxoSmithKlineNULLCompleted30 YearsN/AAll352Phase 4United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland
70NCT01491529
(ClinicalTrials.gov)
April 201212/12/2011Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of Modified Release AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's DiseaseDyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia AgentsDrug: AFQ056;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted30 Years80 YearsAll154Phase 2United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey
71EUCTR2011-002074-23-ES
(EUCTR)
30/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson?s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
92France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
72EUCTR2011-002074-23-SK
(EUCTR)
28/03/201230/03/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
92United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
73EUCTR2011-002074-23-HU
(EUCTR)
21/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
74EUCTR2011-002074-23-DE
(EUCTR)
20/03/201206/02/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe L-dopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Product Name: AFQ056
Product Code: AFQ056
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland
75EUCTR2011-002074-23-IT
(EUCTR)
15/03/201202/03/2012Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias13-week, double-blind, placebo-controlled, fixed-dose, multicenter study to evaluate the efficacy and safety of modified release AFQ056 in reducing moderate to severe Ldopa induced dyskinesias in patients with Parkinson’s disease L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1;Level: HLT;Classification code 10013929;Term: Dyskinesias and movement disorders NEC;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
Product Name: NA
Product Code: AFQ056
INN or Proposed INN: NA
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
92United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy
76EUCTR2011-002901-31-DE
(EUCTR)
08/03/201206/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
77EUCTR2011-004803-19-SE
(EUCTR)
22/02/201216/12/2011PET study in PD patientsA Phase IIA, Multi centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Effect of 8 Weeks Treatment with Oral AZD3241 on Microglia Activation, as Measured by Positron Emission Tomography (PET), in Patients with Parkinson’s Disease Parkinson's Disease; Microglia activation as measured by [11C]PBR28 binding to TSPO
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: AZD3241 Extended release tablets 25 mg
Product Code: AZD3241
Product Name: AZD3241 Extended release tablets 100 mg
Product Code: AZD3241
Product Name: [11C]PBR28
Product Code: [11C]PBR28
Product Name: [18F]FE-PE2I
Product Code: [18F]FE-PE2I
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Finland;Sweden
78NCT01485172
(ClinicalTrials.gov)
January 31, 20121/12/2011A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release in Patients With Early Stage Parkinson's DiseaseA Fixed Dose, Dose Response Study for Ropinirole Prolonged Release (PR) in Patients With Early Stage Parkinson's DiseaseParkinson DiseaseDrug: ropinirole monotherapy;Drug: placebo monotherapyGlaxoSmithKlineNULLCompleted30 YearsN/AAll186Phase 4United States;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland
79NCT01515410
(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
80EUCTR2011-002901-31-HU
(EUCTR)
21/12/201113/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Czech Republic;Hungary;Spain;Germany;United Kingdom
81EUCTR2011-002901-31-CZ
(EUCTR)
12/12/201110/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson’s disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson’s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Hungary;Czech Republic;Spain;Germany;United Kingdom
82EUCTR2011-002901-31-ES
(EUCTR)
30/11/201105/10/2011not applicableA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - A randomised placebo controlled study of OXN PR for severe Parkinson?s disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODO
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Hungary;Czech Republic;Spain;Germany;United Kingdom
83EUCTR2011-002901-31-GB
(EUCTR)
25/11/201121/09/2011A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated painA multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain - Efficacy of OXN PR in severe Parkinson's disease associated pain Subjects will have idiopathic Parkinson's disease and be suffering from severe PD associated pain.
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Targinact 5 mg/2.5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 5 mg /2.5 mg
Product Code: OXN 5 mg/2.5 mg PR
INN or Proposed INN: Oxycodone hydrochloride
Other descriptive name: Oxycodone hydrochloride
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 10 mg/5 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 10 mg /5 mg
Product Code: OXN 10 mg / 5 mg PR
INN or Proposed INN: Oxycodone Hydrochloride
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: Naloxone Hydrochloride Dihydrate
Other descriptive name: NALOXONE HYDROCHLORIDE DIHYDRATE
Trade Name: Targinact 20 mg/10 mg prolonged-release tablets
Product Name: oxycodone/naloxone prolonged release tablets 20 mg /10 mg
Product Code: OXN 20 mg / 10 mg PR
INN or Proposed INN: OXYCODONE HYDROCHLORIDE
Other descriptive name: OXYCODONE HYDROCHLORIDE
INN or Proposed INN: NAL
Mundipharma Research GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
210Phase 3Hungary;Czech Republic;Spain;Germany;United Kingdom
84NCT01457807
(ClinicalTrials.gov)
November 201110/10/2011To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy VolunteersA Phase I, Single-centre, Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Assess the Pharmacokinetics, Safety and Tolerability of Two Different Extended Release Formulations of Tablets of AZD3241 (300 mg) After Administration of Multiple Doses in Healthy Male and Female VolunteersParkinson's DiseaseDrug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2AstraZenecaNULLCompleted30 Years65 YearsBoth24Phase 1United Kingdom
85NCT01439100
(ClinicalTrials.gov)
October 201121/9/2011A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated PainParkinson's Disease With Severe PainDrug: Oxycodone/Naloxone Prolonged Release tablets;Drug: PlaceboMundipharma Research GmbH & Co KGNULLCompleted25 YearsN/ABoth172Phase 3Czech Republic;Germany;Hungary;Poland;Romania;Spain;United Kingdom
86NCT02170376
(ClinicalTrials.gov)
September 201119/6/2014The Effect of BIA 9-1067 at Steady-state on the Levodopa PharmacokineticsThe Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopaBial - Portela C S.A.NULLCompleted18 Years45 YearsAll80Phase 1France
87NCT01411137
(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
88NCT01397422
(ClinicalTrials.gov)
July 201118/7/2011Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)Dyskinesia;Levodopa Induced Dyskinesia;Parkinson's DiseaseDrug: ADS-5102 (extended release amantadine HCl)Adamas Pharmaceuticals, Inc.NULLCompleted30 Years85 YearsAll83Phase 2/Phase 3United States
89NCT01191944
(ClinicalTrials.gov)
August 201030/8/2010Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) PatientsA Double-blind, Double-dummy, Randomised, Parallel-group Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release Versus Pramipexole Immediate Release Administered Orally for 18 Weeks in Chinese Parkinson's Disease (PD) Patients Who Can be Concomitantly Treated With LevodopaParkinson DiseaseDrug: pramipexole immediate release tablet;Drug: pramipexole extended release tabletBoehringer IngelheimNULLCompleted30 YearsN/AAll475Phase 3China
90NCT01097421
(ClinicalTrials.gov)
March 201025/3/2010Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s DiseaseInfluence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's DiseaseParkinson DiseaseDrug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll329N/ASweden
91NCT02169414
(ClinicalTrials.gov)
February 201024/1/2012Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa PharmacokineticsEffect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics of a Single-dose of Immediate Release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy SubjectsParkinson's Disease (PD)Drug: BIA 9-1067 5 mg;Drug: BIA 9-1067 25 mg;Drug: levodopa/carbidopa 100/25;Drug: Placebo;Drug: levodopa/benserazide 100/25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll74Phase 1France
92NCT01568047
(ClinicalTrials.gov)
February 201029/3/2012Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) PatientsMulticentre, Double-blind, Randomised, Placebo-controlled Study in Four Parallel Groups of PD Patients Treated With Standard-release Levodopa/Carbidopa 100/25 mg (Sinemet®) or Levodopa/Benserazide 100/25 mg (Madopar®/Restex®) and With Motor Fluctuations (Wearing-off Phenomenon)Parkinson's DiseaseDrug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/BenzerazideBial - Portela C S.A.NULLCompleted30 YearsN/AAll40Phase 2Romania;Ukraine
93NCT00660387
(ClinicalTrials.gov)
December 200915/4/2008Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo Gel;Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll35Phase 3United States;New Zealand
94EUCTR2009-013004-31-IT
(EUCTR)
02/11/200902/11/2009Early combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons diseaseEarly combined prolonged release ropinirole and rasagiline therapy in newly diagnosed patients with Parkinsons disease. A prospective, randomized, parallel groups, long-term follow-up study including delayed-start design of rasagiline - Early combined ropinirole and rasagiline therapy in patients with Parkinsons disease Patients with Parkinson`s diesease
MedDRA version: 12.0;Level: LLT;Classification code 10061536;Term: Parkinson's disease
INN or Proposed INN: Rasagiline
INN or Proposed INN: Ropinirole
UNIVERSITA` DEGLI STUDI DI PARMANULLNot RecruitingFemale: yes
Male: yes
Italy
95NCT01371682
(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
96NCT00986245
(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
97NCT00918177
(ClinicalTrials.gov)
July 20091/6/2009An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's DiseaseDual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's PatientsParkinson's DiseaseDrug: AP09004;Drug: Carbidopa/Levodopa, immediate releaseIntec Pharma Ltd.NULLCompleted18 YearsN/ABoth72Phase 2Israel
98EUCTR2007-004234-16-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
99EUCTR2007-004235-37-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
100NCT01533116
(ClinicalTrials.gov)
March 200924/1/2012Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/BenserazideEffect of BIA 9-1067 at Steady-state on the Pharmacokinetics of a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa and 100/25 mg Levodopa/Benserazide in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazideBial - Portela C S.A.NULLCompleted25 Years45 YearsAll52Phase 1Canada
101NCT00823836
(ClinicalTrials.gov)
March 200915/1/2009Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's DiseaseClinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's DiseaseParkinson DiseaseDrug: ropinirole PR/XR;Drug: ropinirole IRGlaxoSmithKlineNULLCompleted20 YearsN/AAll302Phase 3Japan
102NCT01533077
(ClinicalTrials.gov)
March 200924/1/2012Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/CarbidopaPharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy SubjectsParkinson DiseaseDrug: BIA 9-1067;Drug: Sinemet® 100/25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsAll18Phase 1Canada
103EUCTR2009-015833-66-IT
(EUCTR)
20/01/200918/04/2012Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate releaseRopinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release Parkinson's Disease
MedDRA version: 14.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: REQUIP*28CPR 8MG R.P.
INN or Proposed INN: ROPINIROLE
Other descriptive name: NA
Trade Name: REQUIP*21CPR 5MG
INN or Proposed INN: ROPINIROLE
Other descriptive name: NA
Trade Name: MIRAPEXIN*30CPR 0,7MG
INN or Proposed INN: PRAMIPEXOLE
Other descriptive name: NA
CASA DI CURA PRIVATA S.RAFFAELE - PISANANULLNot RecruitingFemale: yes
Male: yes
Italy
104NCT02169466
(ClinicalTrials.gov)
January 200920/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/BenserazidePharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBSBial - Portela C S.A.NULLCompleted18 Years45 YearsMale22Phase 1Portugal
105NCT00357994
(ClinicalTrials.gov)
January 200927/7/2006Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's SubjectsA Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor FluctuationsAdvanced Parkinson's DiseaseDrug: Levodopa carbidopa intestinal gel (LCIG);Drug: Placebo gel;Drug: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets;Drug: Placebo (PBO) oral capsules;Device: CADD-Legacy® 1400 ambulatory infusion pump;Device: PEG tube;Device: J-tubeAbbVie (prior sponsor, Abbott)Quintiles, Inc.Completed30 YearsN/AAll36Phase 3United States;Germany
106EUCTR2007-004235-37-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
107NCT02169453
(ClinicalTrials.gov)
October 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/CarbidopaPharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25Bial - Portela C S.A.NULLCompleted18 Years45 YearsMale12Phase 1Canada
108NCT02169479
(ClinicalTrials.gov)
September 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/CarbidopaPharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25Bial - Portela C S.A.NULLCompleted18 Years45 YearsMale16Phase 1Canada
109NCT02169895
(ClinicalTrials.gov)
September 200820/1/2012Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/BenserazidePharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Benserazide: a Doubleblind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male SubjectsParkinson's Disease (PD)Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa®Bial - Portela C S.A.NULLCompleted25 Years45 YearsMale16Phase 1Canada
110EUCTR2007-004235-37-GB
(EUCTR)
19/08/200826/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
111NCT00601978
(ClinicalTrials.gov)
August 200811/1/2008Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease (PD) and End-of-dose Wearing OffA 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Carbidopa/Levodopa/Entacapone on Markers of Event-Related Potentials (ERPs) in Patients With Idiopathic Parkinson's Disease and End-of-Dose Wearing OffParkinson's DiseaseDrug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/EntacaponeNovartis PharmaceuticalsNULLWithdrawn45 Years75 YearsBoth0Phase 4United States
112EUCTR2007-003134-42-DE
(EUCTR)
19/06/200820/02/2008A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off.A 12-Week, Multi-center, Randomized, Prospective, Open-Label, Blinded Rater, Crossover Study of the Effects of Immediate-Release Carbidopa/Levodopa Versus Stalevo® on Markers of Event-Related Potentials (ERPs) in Patients with Idiopathic Parkinson’s Disease and End-of-Dose Wearing Off. Idiopathic Parkinson’s disease and end-of-dose wearing off.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Stalevo 100 mg/ 25 mg/ 200 mg Filmtabletten
Product Name: Stalevo
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
INN or Proposed INN: ENTACAPONE
Trade Name: Nacom 100
Product Name: Nacom
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA
Other descriptive name: CARBIDOPA MONOHYDRATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
20Germany
113EUCTR2007-004235-37-PL
(EUCTR)
29/05/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden
114EUCTR2007-004235-37-SE
(EUCTR)
23/04/200825/03/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim ABNULLNot RecruitingFemale: yes
Male: yes
390Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden
115EUCTR2007-004234-16-FI
(EUCTR)
16/04/200812/02/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
520Hungary;Finland;Czech Republic;Netherlands;France;Austria
116NCT00651183
(ClinicalTrials.gov)
April 200831/3/2008Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentNon-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole TreatmentParkinson DiseaseDrug: Pramipexole immediate releaseBoehringer IngelheimNULLCompleted18 YearsN/AAll286Austria
117EUCTR2007-005033-11-DE
(EUCTR)
27/03/200804/01/2008A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s DiseaseA Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease Patients with Parkinson's DiseaseProduct Name: Levodopa-Carbidopa Multilayer Extended Release Tablet
Product Code: Levodopa-Carbidopa XL tablet (M)
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
Trade Name: Sinemet® CR
Product Name: Sinemet CR
INN or Proposed INN: Levodopa
INN or Proposed INN: Carbidopa
CombinatoRx, IncNULLNot RecruitingFemale: yes
Male: yes
Germany
118EUCTR2007-004235-37-HU
(EUCTR)
17/03/200817/01/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Czech Republic;Hungary;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
119EUCTR2007-004234-16-HU
(EUCTR)
17/03/200817/01/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
120NCT00642356
(ClinicalTrials.gov)
March 200819/3/2008Carbidopa/Levodopa/Entacapone Versus Immediate Release (IR) Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffAn 8-week, Prospective, Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center Comparison Study of the Effects of Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa on Non-motor Symptoms in Patients With Idiopathic Parkinson's Disease and Demonstrating Non-motor Symptoms of Wearing OffParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartisNULLTerminated30 Years85 YearsAll14Phase 4United States
121EUCTR2007-004235-37-ES
(EUCTR)
24/01/200808/03/2010Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD).Estudio abierto de seguridad a largo plazo de pramipexol de liberación prolongada (ER) en pacientes con enfermedad de Parkinson avanzada - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim España, S.A.NULLNot RecruitingFemale: yes
Male: yes
390Phase 3Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden
122EUCTR2007-004234-16-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
123EUCTR2007-004235-37-CZ
(EUCTR)
21/01/200818/12/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
390Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden
124EUCTR2007-004234-16-SK
(EUCTR)
14/01/200818/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
520Phase 3France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
125EUCTR2007-004235-37-SK
(EUCTR)
14/01/200816/04/2008Long-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PDLong-term safety study of open-label pramipexole extended release(ER) in patients with advanced Parkinson’s disease (PD). - Open label extension in advanced PD Male or female patients, with idiopathic PD diagnosed for at least 2 years, 30 years of age or older at time of diagnosis, with a modified Hoehn and Yahr scale of 2 to 4 at on-time.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
390Phase 3Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden
126EUCTR2007-004234-16-FR
(EUCTR)
11/01/200819/11/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
BOEHRINGER INGELHEIMNULLNot RecruitingFemale: yes
Male: yes
520Phase 3France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands
127NCT00601523
(ClinicalTrials.gov)
January 200815/1/2008Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Early Parkinson´s Disease (PD).Parkinson DiseaseDrug: Placebo;Drug: PramipexoleBoehringer IngelheimNULLCompleted30 YearsN/AAll511Phase 3United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina
128NCT00577460
(ClinicalTrials.gov)
December 200719/12/2007Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PDLong-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD)Parkinson DiseaseDrug: Pramipexole;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll391Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
129NCT00558337
(ClinicalTrials.gov)
November 200712/11/2007Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's DiseaseAn Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease PatientsParkinson's DiseaseDrug: levodopa-carbidopaOsmotica Pharmaceutical Corp.NULLCompleted30 Years80 YearsBoth78Phase 2Argentina
130NCT00560508
(ClinicalTrials.gov)
November 200716/11/2007A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment PeriodA Double-blind, Double-dummy, Randomised, Parallel-group Study to Investigate the Safety, Tolerability, Trough Plasma Concentration, and Efficacy of Pramipexole ER Versus Pramipexole Immediate Release (IR) Administered Orally for 12 Weeks in Patients With Parkinson's Disease (PD) on L-dopa Therapy, Followed by a 52-week Open-label Long-term Treatment Period to Evaluate the Long-term Safety and Efficacy of Pramipexole ERParkinson DiseaseDrug: Pramipexole Immediate Release;Drug: Pramipexole Extended ReleaseBoehringer IngelheimNULLCompleted1 YearN/AAll112Phase 2/Phase 3Japan
131EUCTR2007-004234-16-NL
(EUCTR)
29/10/200717/10/2007Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD).Long-term safety study of open-label pramipexole extended release(ER) in patients with early Parkinson’s disease (PD). Male or female patients with early idiopathic Parkinson´s disease (PD) with Modified Hoehn and Yahr stage I-III.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
520Finland;Hungary;Czech Republic;Netherlands;France;Austria
132NCT00558025
(ClinicalTrials.gov)
October 200712/11/2007Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson DiseaseA Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IRParkinson DiseaseDrug: Pramipexole Extended Release;Drug: Pramipexole Immediate ReleaseBoehringer IngelheimNULLCompleted30 YearsN/AAll156Phase 3France;Germany;Netherlands
133EUCTR2007-000073-39-CZ
(EUCTR)
18/06/200718/04/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
134EUCTR2007-000073-39-HU
(EUCTR)
14/06/200731/05/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Finland;Hungary;Czech Republic;Austria
135EUCTR2007-000073-39-SK
(EUCTR)
14/06/200709/04/2008A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Czech Republic;Slovakia;Finland;Austria;Germany
136NCT00460954
(ClinicalTrials.gov)
June 200716/4/2007A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy SubjectsAn Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy SubjectsParkinson's DiseaseDrug: Sinemet® controlled release (Carbidopa/levodopa)Bristol-Myers SquibbNULLCompleted50 Years75 YearsBoth20N/ACanada
137EUCTR2007-000073-39-AT
(EUCTR)
30/05/200705/06/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma Ges mbHNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
138EUCTR2007-000073-39-DE
(EUCTR)
29/05/200726/02/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Czech Republic;Finland;Austria;Germany
139NCT00479401
(ClinicalTrials.gov)
May 200725/5/2007Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD PatientsA Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole ER Versus Placebo and Versus Pramipexole IR Administered Orally Over a 26-week Maintenance Phase in Patients With Early Parkinsons Disease (PD).Early Parkinson Disease (Early PD)Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: PlaceboBoehringer IngelheimNULLCompleted30 YearsN/AAll539Phase 3United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil
140EUCTR2007-000073-39-FI
(EUCTR)
25/04/200706/03/2007A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD)A double-blind, double-dummy, placebo-controlled, randomized, three parallel groups study comparing the Efficacy, Safety and Tolerability of Pramipexole ER versus placebo and versus Pramipexole IR administered orally over a 26-week maintenance phase in patients with early Parkinson's disease (PD) Male or female patients with idiopathic Parkinson’s disease (PD), diagnosed within 5 years, having Modified Hoehn and Yahr stage of 1 to 3.
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Product Name: Pramipexole ER
Product Code: SND 919 CL2 Y
INN or Proposed INN: Pramipexole
Other descriptive name: Prolonged release tablet
Boehringer Ingelheim Finland KyNULLNot RecruitingFemale: yes
Male: yes
500Phase 1Hungary;Finland;Czech Republic;Austria
141NCT00434304
(ClinicalTrials.gov)
April 9, 20079/2/2007Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease (PD)Clinical Evaluation of Ropinirole PR/XR Tablets in Monotherapy for Parkinson's Disease - an Open-Label, Uncontrolled Study -Parkinson DiseaseDrug: Ropinirole prolonged release/extended release(PR/XR)GlaxoSmithKlineNULLCompleted20 YearsN/AAll62Phase 2Japan
142NCT00466167
(ClinicalTrials.gov)
April 200725/4/2007Pivotal Study in Advanced Parkinsons Disease PatientsA Double-blind, Double-dummy, Placebo-controlled, Randomized, Three Parallel Groups Study Comparing the Efficacy, Safety and Tolerability of Pramipexole Extended Release (ER) Versus Placebo and Versus Pramipexole Immediate Release (IR) Administered Orally Over a 26-week Maintenance Phase in L-Dopa+ Treated Patients With Advanced Parkinsons Disease (PD).Parkinson DiseaseDrug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: PlaceboBoehringer IngelheimNULLCompleted32 YearsN/AAll517Phase 3Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom
143NCT00460148
(ClinicalTrials.gov)
April 200711/4/2007Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of RopiniroleAn Open Label, Repeat Dose, Dose Escalation Study Conducted in Parkinson's Disease Patients to Characterize the Pharmacokinetics and Effect of Food on Ropinirole Prolonged Release (PR/CR) 12mg Tablets.Parkinson DiseaseDrug: RopiniroleGlaxoSmithKlineNULLCompleted30 Years85 YearsBoth28Phase 2Germany;South Africa
144EUCTR2006-006209-94-DE
(EUCTR)
15/03/200726/01/2007An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets.An open label, repeat dose, dose escalation study conducted in Parkinson’s Disease patients to characterize the pharmacokinetics and effect of food on ropinirole prolonged release (PR/CR) 12mg tablets. Parkinson's disease
MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Trade Name: Requip-Modutab
Product Name: Requip-Modutab
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
Trade Name: Requip-Modutab
Product Name: Requip-Modutab
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
Trade Name: Requip-Modutab
Product Name: Requip-Modutab
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
Product Name: Ropinirole
Product Code: SK&F101468
INN or Proposed INN: Ropinirole
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
36Germany
145NCT00465452
(ClinicalTrials.gov)
January 200724/4/2007Impact of Switching to Continuous Release Dopamine AgonistsThe Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side EffectsParkinson DiseaseDrug: Continuous Release Dopamine AgonistsUniversity of Toledo Health Science CampusNULLCompleted55 YearsN/ABoth15Phase 3United States
146EUCTR2005-005423-34-HU
(EUCTR)
04/09/200605/07/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's disease
MedDRA version: 8.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
147NCT00331149
(ClinicalTrials.gov)
June 20, 200626/5/2006A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson'sA Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment With Ropinirole Immediate Release Tablets (REQUIP IR) or Ropinirole Prolonged Release Tablets (SK&F-101468) in Advanced Stage Parkinson's Disease Subjects Who Are Not Adequately Controlled on L-dopa.Parkinson DiseaseDrug: Ropinirole prolonged release;Drug: ropinirole immediate releaseGlaxoSmithKlineNULLCompleted30 YearsN/AAll343Phase 3Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic
148EUCTR2005-005423-34-DE
(EUCTR)
19/06/200602/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
149EUCTR2005-005423-34-ES
(EUCTR)
19/05/200629/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
GlaxoSmithKlineNULLNot RecruitingFemale: yes
Male: yes
516Phase 3Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom
150EUCTR2005-005423-34-GB
(EUCTR)
11/05/200617/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
GlaxoSmithKline Research & Development LtdNULLNot Recruiting Female: yes
Male: yes
516 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Czech Republic;Spain;Germany;Italy;United Kingdom
151EUCTR2005-005423-34-IT
(EUCTR)
08/05/200603/10/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - NDA Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release IR Tablets or Ropinirole Prolonged Release / Extended Release PR/XR Tablets in Advanced Stage Parkinson s Disease Subjects who are not Adequately Controlled on L-dopa. - ND Parkinson disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Product Name: ropinirole PR/XR tablets
Product Code: SKF-101468A
INN or Proposed INN: Ropinirole
Trade Name: REQUIP*21CPR 0,25MG
INN or Proposed INN: Ropinirole
Product Name: ropinirole PR/XR tablets
Product Code: SKF-101468A
INN or Proposed INN: Ropinirole
Product Name: ropinirole PR/XR tablets
Product Code: SKF-101468A
INN or Proposed INN: Ropinirole
Trade Name: REQUIP*21CPR 0,5MG
INN or Proposed INN: Ropinirole
Trade Name: REQUIP*21CPR 1MG
INN or Proposed INN: Ropinirole
GlaxoSmithKline R DNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy
152EUCTR2005-005423-34-CZ
(EUCTR)
20/04/200603/03/2006A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa.A Randomised, Double-Blind, Double-Dummy, Parallel Group Comparison of 24 Weeks of Treatment with Ropinirole Immediate Release (IR) Tablets or Ropinirole Prolonged Release / Extended Release (PR/XR) Tablets in Advanced Stage Parkinson’s Disease Subjects who are not Adequately Controlled on L-dopa. Parkinson's diseaseProduct Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole PR/XR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
INN or Proposed INN: Ropinirole
Other descriptive name: Ropinirole hydrochloride
Product Name: Ropinirole IR Tablets
GlaxoSmithKline Research & Development LtdNULLNot RecruitingFemale: yes
Male: yes
516Hungary;United Kingdom;Germany;Czech Republic;Spain;Italy
153EUCTR2005-001032-72-PT
(EUCTR)
23/03/200611/11/2005A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First StepA 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step Parkinson diseaseTrade Name: Stalevo
Product Code: ELC200
INN or Proposed INN: levodopa/carbidopa/entacapone
Trade Name: SINEMET
Product Name: sinemet
INN or Proposed INN: levodopa/carbidopa
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
154EUCTR2005-001032-72-CZ
(EUCTR)
16/02/200612/01/2006A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First StepA 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 (t.i.d.) vs. immediate release carbidopa/levodopa (t.i.d.) in Parkinson's disease patients requiring levodopa. - First Step Trade Name: Stalevo 100 mg/25 mg / 200 mg
Product Code: ELC200
Trade Name: SINEMET CR
Product Name: SINEMET CR
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
155NCT00275275
(ClinicalTrials.gov)
January 20069/1/2006Pramipexole Conversion to Ropinirole Controlled Release (CR)An Open Label Conversion Study of Pramipexole to Ropinirole Controlled Release (CR) in Patients With Parkinson's Disease.Parkinson DiseaseDrug: Requip PR;Drug: MirapexRajesh Pahwa, MDGlaxoSmithKlineCompleted18 YearsN/AAll61Phase 3United States
156EUCTR2005-001032-72-IT
(EUCTR)
25/11/200526/03/2007A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa.A 39-week randomized, double-blind, parallel group, multicenter study to evaluate the effect of fixed dose Stalevo 100 t.i.d. vs. immediate release carbidopa/levodopa t.i.d. in Parkinsons disease patients requiring levodopa. Parkinson s Disease
MedDRA version: 6.1;Level: PT;Classification code 10061536
Trade Name: Stalevo
INN or Proposed INN: ENTACAPONE INN
INN or Proposed INN: LEVODOPA INN
INN or Proposed INN: CARBIDOPA INN
Trade Name: Sinemet
INN or Proposed INN: LEVODOPA
INN or Proposed INN: CARBIDOPA ANIDRA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
424Portugal;Czech Republic;Italy
157NCT00253084
(ClinicalTrials.gov)
November 200511/11/2005Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's DiseaseA Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's DiseaseParkinson's DiseaseDrug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR PlaceboImpax Laboratories, LLCNULLCompleted30 YearsN/AAll12Phase 2United States
158NCT02778594
(ClinicalTrials.gov)
September 200518/5/2016Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/BenserazidePharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide (Madopar® HBS 125): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy VolunteersParkinson's Disease (PD)Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mgBial - Portela C S.A.NULLCompleted18 Years45 YearsBoth17Phase 1Portugal
159NCT02774564
(ClinicalTrials.gov)
September 200513/5/2016Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/CarbidopaPharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 3-202 and a Single Dose of Controlled-release 200/50 mg Levodopa/Carbidopa (Sinemet® cr 200/50): a Double-blind, Randomised, Four-way Crossover, Placebo-controlled Study in Healthy VolunteersParkinson's DiseaseDrug: BIA 3-202;Drug: Placebo;Drug: Sinemet®Bial - Portela C S.A.NULLCompleted18 Years45 YearsBoth16Phase 1Portugal
160NCT00134966
(ClinicalTrials.gov)
August 200523/8/2005A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/LevodopaA 39 Week Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Effect of Fixed Dose Carbidopa/Levodopa/Entacapone 100 mg t.i.d. vs. Immediate Release Carbidopa/Levodopa 25/100 mg (t.i.d.) in Parkinson's Disease Patients Requiring LevodopaParkinson's DiseaseDrug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg)NovartisNULLCompleted30 Years80 YearsAll493Phase 3United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic
161NCT00144300
(ClinicalTrials.gov)
January 20052/9/2005Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) PatientsA Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease PatientsParkinson DiseaseDrug: Mirapex;Drug: RequipBoehringer IngelheimNULLCompleted30 YearsN/AAll246Phase 4United States
162NCT00099268
(ClinicalTrials.gov)
September 200410/12/2004Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyA Long Term, Double-blind, Randomized, Parallel-group, Carbidopa/Levodopa Controlled, Multi-center Study to Evaluate the Effect of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa TherapyParkinson's DiseaseDrug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopaNovartis PharmaceuticalsOrion Corporation, Orion PharmaCompleted30 Years70 YearsAll747Phase 3United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom
163NCT00174239
(ClinicalTrials.gov)
July 20049/9/2005Study Of Cabaser and Sinemet CR For The Treatment Of Nighttime Symptoms Associated With Parkinson's Disease.A Double-Blind, Randomized, Comparative Study of Cabaser and Sinemet CR For The Treatment Of Nocturnal Disability In Levodopa -Treated Parkinson's Disease Patients.Parkinson DiseaseDrug: cabergoline;Drug: controlled-release levodopa / carbidopaPfizerNULLTerminated18 Years80 YearsBoth220Phase 4Australia;Italy;Spain;United Kingdom
164NCT00632736
(ClinicalTrials.gov)
February 20044/3/2008An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s DiseaseAn Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169Parkinson Disease;Parkinson's DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll419Phase 3United States;Belgium;Czech Republic;France;Hungary;Italy;Poland;Spain;United Kingdom;Germany;Philippines
165NCT00363727
(ClinicalTrials.gov)
December 20037/8/2006Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson'sA Two Year Phase IIIb Randomised, Multicenter, Double-blind, SINEMET Controlled, Parallel Group, Flexible Dose Study, to Assess the Effectiveness of Controlled Release Ropinirole add-on Therapy to L-dopa at Increasing the Time to Onset of Dyskinesia in Parkinson's Disease Subjects.Parkinson's Disease;Parkinson Disease;DyskinesiasDrug: ropinirole controlled-release (REQUIP CR) for RLSGlaxoSmithKlineNULLCompleted30 Years70 YearsAll209Phase 3United States
166NCT00650104
(ClinicalTrials.gov)
May 200227/3/2008Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164101648/196: A Long-Term, Open-Label Continuation Study of Once Daily Administration of Ropinirole CR Tablets to Patients With Parkinson's Disease Who Completed the Previous Ropinirole CR Studies 167 or 164Parkinson DiseaseDrug: Ropinirole XL (formerly CR)GlaxoSmithKlineNULLCompleted30 YearsN/AAll76Phase 3United States;Belgium;France;Netherlands;Norway