6. パーキンソン病 Parkinson disease Clinical trials / Disease details
臨床試験数 : 2,307 / 薬物数 : 2,007 - (DrugBank : 349) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05307770 (ClinicalTrials.gov) | May 1, 2022 | 23/3/2022 | Extended-Release Melatonin in Patients With Rapid Eye Movement Sleep Behavior Disorder | Randomized, Double-Blind, Cross-Over Study Comparing the Efficacy of Immediate and Extended-Release Melatonin as a Supplement Affecting the Sleep Cycle in Patients With Parkinson Disease and Rapid Eye Movement Sleep Behavior Disorder | Rapid Eye Movement Sleep Behavior Disorder;Parkinson Disease | Dietary Supplement: Immediate Release Melatonin;Dietary Supplement: Extended Release Melatonin | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 50 | N/A | United States |
| 2 | NCT04952194 (ClinicalTrials.gov) | January 1, 2022 | 3/6/2021 | Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease | Clinical Study of Stalevo in the Treatment of Early Parkinson's Disease | Parkinson Disease | Drug: Stalevo;Drug: Carbidopa and Levodopa Controlled Release Tablets | Second Affiliated Hospital, School of Medicine, Zhejiang University | NULL | Recruiting | 30 Years | 70 Years | All | 180 | Phase 4 | China |
| 3 | NCT05128175 (ClinicalTrials.gov) | October 29, 2021 | 27/10/2021 | Comparative Bioavailability Study of Carbidopa/Levodopa Extended-Release Tablets Under Fasting and Fed Conditions | An 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 Conditions | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 18 Years | 45 Years | All | 15 | Phase 1 | India |
| 4 | NCT05036473 (ClinicalTrials.gov) | October 12, 2021 | 10/8/2021 | A Study of the Efficacy and Safety of Carbidopa-Levodopa Extended-Release Tablets in Patients With Parkinson's Disease | A 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 Disease | Parkinson Disease | Drug: WD-1603 Carbidopa-Levodopa Extended-Release Tablets;Drug: Placebo | Shanghai WD Pharmaceutical Co., Ltd. | NULL | Recruiting | 30 Years | 75 Years | All | 40 | Phase 2 | China |
| 5 | NCT04387773 (ClinicalTrials.gov) | November 5, 2020 | 11/5/2020 | Effect of GOCOVRI (Amantadine, Extended Release Capsules) on Gait in Parkinson's Disease | Effect of GOCOVRI on Quantity and Quality of Gait in Parkinson's Disease | Parkinson Disease | Drug: GOCOVRI | Oregon Health and Science University | Adamas Pharmaceuticals, Inc. | Completed | 50 Years | 80 Years | All | 8 | Phase 4 | United States |
| 6 | NCT04591535 (ClinicalTrials.gov) | September 28, 2020 | 11/9/2020 | PK Study of WD-1603 in Healthy Subjects | An 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 Conditions | Parkinson Disease | Drug: WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
| 7 | ChiCTR2000035564 | 2020-08-17 | 2020-08-13 | Pharmacokinetics and Bioequivalence study of Pramipexole Extended-Release Tablets in Healthy Chinese Volunteers | Pharmacokinetics and Bioequivalence study of Pramipexole Extended-Release Tablets in Healthy Chinese Volunteers | Parkinson’s disease | fasting 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 University | NULL | Recruiting | 18 | 65 | Both | fasting administration group-TR:28;fasting administration group-RT:28;high-fat postprandial administration group-TR:28;high-fat postprandial administration group-RT:28; | Phase 1 | China |
| 8 | NCT04513340 (ClinicalTrials.gov) | August 13, 2020 | 12/8/2020 | WD-1603 PK Study Under Fasting and Fed Conditions in Healthy Subjects | AN 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 CONDITIONS | Parkinson Disease | Drug: WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS | Hong Kong WD Pharmaceutical Co., Limited | NULL | Recruiting | 18 Years | 45 Years | All | 8 | Phase 1 | India |
| 9 | NCT04275492 (ClinicalTrials.gov) | July 24, 2020 | 18/11/2019 | Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets | Study on Bioequivalence of Pramipexole Dihydrochloride Sustained Release Tablets | Parkinson's Disease | Drug: 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 University | Hongguan biological pharmaceutical co. | Recruiting | 18 Years | 45 Years | All | 60 | N/A | China |
| 10 | NCT04384666 (ClinicalTrials.gov) | June 2, 2020 | 8/5/2020 | A 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 Volunteers | A 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 Volunteers | Parkinson Disease | Drug: LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection);Other: Neupro 4 mg / 24 Hr. Transdermal Patch | Luye Pharma Group Ltd. | NULL | Completed | 18 Years | 45 Years | All | 56 | Phase 1 | United States |
| 11 | NCT04571164 (ClinicalTrials.gov) | May 11, 2020 | 21/9/2020 | A Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | A Multi-centre,Randomized,Double-blind,Placebo Parallel Controlled Study to Evaluate the Effectiveness and Safety of LY03003 in Patients With Early Primary PD | Parkinson Disease | Drug: LY03003(Rotigotine,extended-release microspheres);Drug: Placebo,extended-release microspheres | Luye Pharma Group Ltd. | Parexel | Recruiting | 30 Years | N/A | All | 294 | Phase 3 | China |
| 12 | EUCTR2018-002233-37-PL (EUCTR) | 23/04/2020 | 24/01/2020 | Evaluate 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, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Canada;Spain;Poland;Germany;United Kingdom;Italy | ||
| 13 | NCT04232969 (ClinicalTrials.gov) | January 20, 2020 | 10/1/2020 | Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease | A Randomised, Double Blind, Parallel Group, Placebo Controlled, Phase 3 Trial of Exenatide Once Weekly Over 2 Years as a Potential Disease Modifying Treatment for Parkinson's Disease | Parkinson's Disease | Drug: Exenatide extended release 2mg (Bydureon) | University College, London | NULL | Active, not recruiting | 25 Years | 80 Years | All | 194 | Phase 3 | United Kingdom |
| 14 | EUCTR2019-000732-26-SE (EUCTR) | 23/10/2019 | 07/05/2019 | Exenatide Treatment in Parkinson's Disease | Effect 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 Services | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Sweden | ||
| 15 | EUCTR2018-002233-37-GB (EUCTR) | 11/10/2019 | 14/02/2019 | Evaluate 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, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;Italy;United Kingdom | ||
| 16 | EUCTR2018-002233-37-IT (EUCTR) | 03/05/2019 | 07/01/2021 | Evaluate 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, LLC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 510 | Phase 3 | France;United States;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 17 | EUCTR2018-002233-37-DE (EUCTR) | 17/04/2019 | 08/01/2019 | Evaluate 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, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czechia;Poland;Spain;Germany;United Kingdom;Italy | ||
| 18 | EUCTR2018-002233-37-CZ (EUCTR) | 18/03/2019 | 11/12/2018 | Evaluate 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, LLC | NULL | Not Recruiting | Female: yes Male: yes | 510 | Phase 3 | United States;France;Czech Republic;Poland;Spain;Germany;United Kingdom;Italy | ||
| 19 | NCT03670953 (ClinicalTrials.gov) | November 6, 2018 | 12/9/2018 | A Study to Evaluate the Safety and Efficacy of IPX203 in Parkinson's Disease Patients 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 (Disorder) | Drug: IR CD-LD;Drug: IPX203 ER CD-LD;Other: IPX203 placebo;Other: IR CD-LD placebo | Impax Laboratories, LLC | NULL | Completed | 40 Years | N/A | All | 631 | Phase 3 | United States;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom |
| 20 | EUCTR2018-001209-95-IT (EUCTR) | 05/07/2018 | 03/08/2021 | An 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 | An 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 LTD | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Spain;Italy | ||
| 21 | NCT03521635 (ClinicalTrials.gov) | July 3, 2018 | 11/4/2018 | The 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-Dopa | A 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 Disease | Drug: Pramipexole SR;Drug: Pramipexole IR | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 98 | Phase 4 | China |
| 22 | NCT03576638 (ClinicalTrials.gov) | July 2018 | 25/6/2018 | Study to Assess Pharmacokinetics of Accordion Pill Carbidopa-Levodopa Compared to Immediate Release Carbidopa-Levodopa in Parkinson's Disease Patients | An 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 Disease | Parkinson Disease | Drug: Accordion Pill Carbidopa/Levodopa;Drug: Sinemet CR 25Mg-100Mg Extended-Release Tablet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 12 | Phase 2 | NULL |
| 23 | EUCTR2017-001420-21-DE (EUCTR) | 18/06/2018 | 16/02/2018 | Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 24 | EUCTR2017-001420-21-ES (EUCTR) | 13/06/2018 | 15/03/2018 | Clinical Efficacy, Safety and Tolerability of P2B001 in Early Parkinson's Disease | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Phase 3 | United States;France;Canada;Spain;Germany | ||
| 25 | NCT04045678 (ClinicalTrials.gov) | October 10, 2017 | 30/7/2019 | A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's Disease | A 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 Injections | Parkinson Disease | Drug: LY03003 ( Rotigotine, extended-release microspheres);Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 30 | Phase 1 | China |
| 26 | NCT03250117 (ClinicalTrials.gov) | October 10, 2017 | 11/8/2017 | Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole | An 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-Dopa | Parkinson Disease | Drug: Ropinirole oral product;Drug: Ropinirole Implant | Titan Pharmaceuticals | NULL | Terminated | 30 Years | 80 Years | All | 3 | Phase 1/Phase 2 | United States |
| 27 | EUCTR2015-004344-19-DE (EUCTR) | 07/02/2017 | 27/09/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A 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 | ApoPharma | NULL | Not 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): no | France;Canada;Germany;United Kingdom | ||
| 28 | NCT02728843 (ClinicalTrials.gov) | October 12, 2016 | 31/3/2016 | Study of Parkinson's Early Stage With Deferiprone | A Dose-Ranging Study of the Efficacy, Safety, and Pharmacokinetics of Deferiprone Delayed Release Tablets in Patients With Parkinson's Disease | Parkinson's Disease | Drug: Deferiprone;Drug: Placebo | ApoPharma | NULL | Completed | 18 Years | 80 Years | All | 140 | Phase 2 | Canada;France;Germany;United Kingdom |
| 29 | NCT02601586 (ClinicalTrials.gov) | September 2016 | 17/8/2015 | Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease | Evaluation of the Analgesic Effects of Prolonged-release Oxycodone and of Levodopa, Versus Placebo, on Central Neuropathic Pain in Parkinson's Disease: OXYDOPA Trial | Parkinson Disease | Drug: PR Oxycodone;Drug: Levodopa;Drug: Oxycodone Placebo;Drug: Levodopa placebo | University Hospital, Toulouse | NULL | Completed | 40 Years | 75 Years | All | 67 | Phase 2/Phase 3 | France |
| 30 | NCT02789592 (ClinicalTrials.gov) | July 2016 | 31/5/2016 | Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease | A 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 Disease | REM Sleep Behavior Disorder;Parkinson Disease | Drug: Melatonin PR;Drug: Clonazepam;Drug: Melatonin PR placebo;Drug: Clonazepam placebo | Seoul National University Hospital | Kuhnil Pharmaceutical Co., Ltd. | Not yet recruiting | 30 Years | N/A | Both | 30 | Phase 2 | Korea, Republic of |
| 31 | EUCTR2015-004344-19-FR (EUCTR) | 29/06/2016 | 20/04/2016 | An international trial of deferiprone in patients with parkinson’s disease | A 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. | NULL | Not 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): no | United States;France;Canada;Germany;Italy;United Kingdom | ||
| 32 | EUCTR2015-003512-20-PL (EUCTR) | 22/06/2016 | 01/04/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 33 | EUCTR2015-003512-20-IT (EUCTR) | 08/06/2016 | 05/11/2020 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson¿s Disease | A 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 LTD | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | United States;Hungary;Slovakia;Spain;Poland;Ukraine;Russian Federation;Israel;Bulgaria;Germany;United Kingdom;Italy | ||
| 34 | EUCTR2015-003512-20-ES (EUCTR) | 18/05/2016 | 18/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson?s Disease | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 35 | EUCTR2015-003512-20-HU (EUCTR) | 09/05/2016 | 02/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 36 | EUCTR2015-003512-20-GB (EUCTR) | 28/04/2016 | 03/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A 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. | NULL | Not 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): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Russian Federation;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 37 | EUCTR2015-003512-20-SK (EUCTR) | 22/04/2016 | 04/03/2016 | Clinical Efficacy & Safety of AP CD/LD in Fluctuating Parkinson’s Disease | A 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. | NULL | Not 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): no | United States;Hungary;Slovakia;Poland;Spain;Ukraine;Israel;Bulgaria;Germany;Italy;United Kingdom | ||
| 38 | EUCTR2015-004344-19-GB (EUCTR) | 31/03/2016 | 16/02/2016 | An international trial of deferiprone in patients with Parkinson’s disease | A 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 | ApoPharma | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;Canada;Germany;United Kingdom | ||
| 39 | EUCTR2015-001523-24-FR (EUCTR) | 25/03/2016 | 20/04/2016 | Evaluation 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 | UHToulouse | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2;Phase 3 | France | ||
| 40 | NCT02605434 (ClinicalTrials.gov) | March 2016 | 5/11/2015 | A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients | Phase 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 Patients | Parkinson's Disease | Drug: Accordion Pill™ Carbidopa/Levodopa;Drug: Sinemet®;Drug: Placebo -AP-CD/LD;Drug: Placebo- Sinemet | Intec Pharma Ltd. | NULL | Unknown status | 30 Years | N/A | All | 420 | Phase 3 | United States;Bulgaria;Germany;Israel;Italy;Poland;Slovakia;Spain;Ukraine;United Kingdom;Hungary |
| 41 | EUCTR2015-002631-17-ES (EUCTR) | 19/11/2015 | 03/11/2015 | A study comparing immediate-release oral Levodopa and L-dopa/carbidopa intestinal gel over cognition and mood in non-demented Parkinson?s disease (PD) patients | An 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 Pau | NULL | Not 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): yes | Spain | ||
| 42 | EUCTR2014-003738-24-AT (EUCTR) | 26/06/2015 | 01/04/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-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. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | Germany;Spain;Austria;United States | ||
| 43 | EUCTR2014-003739-20-AT (EUCTR) | 19/06/2015 | 01/04/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Spain;Austria;Germany | ||
| 44 | EUCTR2014-003738-24-DE (EUCTR) | 23/04/2015 | 21/01/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-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. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | United States;Spain;Austria;Germany | ||
| 45 | EUCTR2014-003739-20-DE (EUCTR) | 23/04/2015 | 21/01/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-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. | NULL | Not 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): no | France;United States;Spain;Austria;Germany | ||
| 46 | JPRN-JapicCTI-152870 | 11/4/2015 | 14/04/2015 | A parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA | A phase III parallel group comparison study of HP-3000 in patients with Parkinson's disease using L-DOPA | Parkinson's disease | Intervention 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. | NULL | 20 | 79 | BOTH | Phase 3 | NULL | ||
| 47 | EUCTR2014-003739-20-FR (EUCTR) | 10/04/2015 | 19/06/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-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. | NULL | Not 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): no | United States;France;Spain;Austria;Germany | ||
| 48 | EUCTR2014-003738-24-ES (EUCTR) | 24/03/2015 | 16/02/2015 | A clinical trial to see if ADS-5102 is safe and effective in people with drug induced abnormal movements in Parkinson's disease | ADS-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. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | United States;Spain;Austria;Germany | ||
| 49 | EUCTR2014-003739-20-ES (EUCTR) | 24/03/2015 | 16/02/2015 | A clinical trial to see if ADS-5102 is safe in people with drug induced abnormal movements in Parkinson's disease | Open-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. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Spain;Austria;Germany | ||
| 50 | EUCTR2014-001132-10-FR (EUCTR) | 18/11/2014 | 18/06/2015 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson’s Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 162 | United States;France;Canada;Spain;Germany | |||
| 51 | EUCTR2014-000335-17-GB (EUCTR) | 28/10/2014 | 23/07/2014 | Rotigotine 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 Staffordshire | Keele University | Not Recruiting | Female: yes Male: yes | 0 | United Kingdom | |||
| 52 | EUCTR2014-001132-10-ES (EUCTR) | 23/10/2014 | 02/09/2014 | A 26 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 53 | EUCTR2014-001131-36-ES (EUCTR) | 23/10/2014 | 03/09/2014 | A 16 Week Clinical Study to Evaluate the Use of Long-Acting Amantadine to Treat Parkinson's Disease Patients with Abnormal Involuntary Movements caused by Levodopa | 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 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. | NULL | Not Recruiting | Female: yes Male: yes | 162 | Phase 3 | France;United States;Canada;Spain;Germany | ||
| 54 | NCT02274766 (ClinicalTrials.gov) | October 2014 | 22/10/2014 | Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia | ADS-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: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 77 | Phase 3 | United States;Austria;France;Germany;Spain |
| 55 | ChiCTR-TRC-14005143 | 2014-08-25 | 2014-08-14 | A traditional chinese medicine clinical intervention study of depressed Parkinson's disease - based on the Wenyang Jieyu method | A traditional chinese medicine clinical intervention study of depressed Parkinson's disease - based on the Wenyang Yieyu method | Depressed Parkinson's disease | Chinese Medicines:Formula granule;Western Medicine group:Venlafaxine hydrochloride sustained-release capsules ; | The Third Affiliated Hospital of Beijing University of Traditional Chinese Medicine | NULL | Recruiting | 55 | 75 | Both | Chinese Medicines:60;Western Medicine group:60; | 2 (Phase 2 study) | China |
| 56 | NCT02153645 (ClinicalTrials.gov) | August 18, 2014 | 30/5/2014 | Efficacy 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 Dyskinesias | Parkinson's Disease;Levodopa Induced Dyskinesias (LID) | Drug: 240mg Amantadine HCl ER tablets;Drug: Placebo tablets;Drug: 320mg Amantadine HCl ER tablets | Adamas Pharmaceuticals, Inc. | NULL | Terminated | 30 Years | 85 Years | All | 87 | Phase 3 | United States;Canada;France;Germany;Spain |
| 57 | NCT02153632 (ClinicalTrials.gov) | July 30, 2014 | 30/5/2014 | Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID | A 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;Levodopa Induced Dyskinesia (LID) | Drug: amantadine HCl ER;Drug: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Terminated | 30 Years | 85 Years | All | 135 | Phase 3 | United States;Canada;France;Germany;Spain |
| 58 | NCT02202551 (ClinicalTrials.gov) | July 2014 | 25/7/2014 | Open-Label Safety Study of ADS-5102 in PD Patients With LID | Open-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-5102 | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 223 | Phase 3 | United States;Austria;Canada;France;Germany;Spain |
| 59 | NCT02136914 (ClinicalTrials.gov) | May 2014 | 9/5/2014 | ADS-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 Disease | Drug: ADS-5102;Other: Placebo | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 126 | Phase 3 | United States;Canada |
| 60 | NCT04044547 (ClinicalTrials.gov) | November 22, 2013 | 30/7/2019 | A Study of LY03003 in Patients With Early-stage Parkinson's Disease | A 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 Injections | Parkinson Disease | Drug: Rotigotine, extended-release microspheres;Drug: Placebo, extended-release microspheres | Luye Pharma Group Ltd. | Beijing Bozhiyin T&S Co., Ltd. | Completed | 18 Years | 75 Years | All | 60 | Phase 1 | NULL |
| 61 | EUCTR2011-002827-17-SK (EUCTR) | 17/09/2013 | 04/03/2013 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Estonia;Slovakia;Russian Federation;Korea, Republic of | |||
| 62 | NCT01929317 (ClinicalTrials.gov) | August 28, 2013 | 22/8/2013 | A 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 Disease | Drug: Ropinirole CR 2mg tablet;Drug: Ropinirole CR 8mg tablet;Drug: Ropinirole CR matching Placebo tablet | GlaxoSmithKline | NULL | Terminated | 20 Years | N/A | All | 81 | Phase 3 | Japan |
| 63 | EUCTR2011-002828-41-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Taiwan;Estonia;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 64 | EUCTR2011-002827-17-EE (EUCTR) | 23/04/2013 | 08/02/2013 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 210 | United States;Estonia;Slovakia;Russian Federation;Korea, Republic of | |||
| 65 | EUCTR2011-002828-41-SK (EUCTR) | 27/03/2013 | 04/03/2013 | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 406 | United States;Estonia;Taiwan;Slovakia;Argentina;Chile;Russian Federation;Korea, Republic of | |||
| 66 | NCT01736176 (ClinicalTrials.gov) | March 2013 | 27/11/2012 | A 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 Disease | An 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 Disease | Advanced Parkinson's Disease | Drug: Levodopa-Carbidopa Intestinal Gel;Procedure: Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J);Drug: Levodopa-carbidopa Immediate Release (LC-IR) Tablets | AbbVie (prior sponsor, Abbott) | NULL | Completed | 30 Years | N/A | All | 39 | Phase 3 | United States |
| 67 | EUCTR2012-000801-64-GB (EUCTR) | 09/02/2013 | 26/11/2012 | A study of the effects of medication on memory in Parkinson's Disease | A 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 Staffordshire | Keele University | Not Recruiting | Female: yes Male: yes | 55 | Phase 4 | United Kingdom | ||
| 68 | EUCTR2011-004803-19-FI (EUCTR) | 16/08/2012 | 16/05/2012 | PET study in PD patients | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 69 | EUCTR2011-002074-23-AT (EUCTR) | 05/06/2012 | 07/05/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 70 | NCT01494532 (ClinicalTrials.gov) | April 2, 2012 | 1/12/2011 | A Fixed Dose Study of Ropinirole Prolonged Release as Adjunctive Treatment in Patients With Advanced 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 | Parkinson Disease | Drug: ropinirole/L-dopa;Drug: placebo/L-dopa | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 352 | Phase 4 | United States;Argentina;Chile;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 71 | NCT01491529 (ClinicalTrials.gov) | April 2012 | 12/12/2011 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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 | Dyskinesias;Parkinson Disease;Movement Disorders;Parkinsonian Disorders;Anti-Dyskinesia Agents | Drug: AFQ056;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 30 Years | 80 Years | All | 154 | Phase 2 | United States;Austria;Canada;France;Germany;Hungary;Italy;Slovakia;Spain;Switzerland;Turkey |
| 72 | EUCTR2011-002074-23-ES (EUCTR) | 30/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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. | NULL | Not Recruiting | Female: yes Male: yes | 92 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 73 | EUCTR2011-002074-23-SK (EUCTR) | 28/03/2012 | 30/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 74 | EUCTR2011-002074-23-HU (EUCTR) | 21/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 75 | EUCTR2011-002074-23-DE (EUCTR) | 20/03/2012 | 06/02/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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 AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | France;United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Italy;Switzerland | |||
| 76 | EUCTR2011-002074-23-IT (EUCTR) | 15/03/2012 | 02/03/2012 | Evaluation of the Efficacy and Safety of Modified Release AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias | 13-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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 92 | United States;Hungary;Slovakia;Canada;Spain;Turkey;Austria;Germany;Switzerland;Italy | |||
| 77 | EUCTR2011-002901-31-DE (EUCTR) | 08/03/2012 | 06/10/2011 | not applicable | A 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 78 | EUCTR2011-004803-19-SE (EUCTR) | 22/02/2012 | 16/12/2011 | PET study in PD patients | A 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Finland;Sweden | ||
| 79 | NCT01485172 (ClinicalTrials.gov) | January 31, 2012 | 1/12/2011 | A Fixed Dose, Dose Response Study for Ropinirole Prolonged Release 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 | Parkinson Disease | Drug: ropinirole monotherapy;Drug: placebo monotherapy | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 186 | Phase 4 | United States;Estonia;Korea, Republic of;Russian Federation;Slovakia;Poland |
| 80 | NCT01515410 (ClinicalTrials.gov) | January 2012 | 11/1/2012 | Study in Advanced Parkinson's Disease Patients With Predictable Motor Fluctuations | A 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 Fluctuations | Parkinson's Disease;Motor Fluctuations | Drug: DM-1992;Drug: Sinemet IR | Depomed | NULL | Completed | 30 Years | N/A | All | 34 | Phase 2 | United States |
| 81 | EUCTR2011-002901-31-HU (EUCTR) | 21/12/2011 | 13/10/2011 | not applicable | A 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Czech Republic;Hungary;Spain;Germany;United Kingdom | |||
| 82 | EUCTR2011-002901-31-CZ (EUCTR) | 12/12/2011 | 10/10/2011 | not applicable | A 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Hungary;Czech Republic;Spain;Germany;United Kingdom | |||
| 83 | EUCTR2011-002901-31-ES (EUCTR) | 30/11/2011 | 05/10/2011 | not applicable | A 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 84 | EUCTR2011-002901-31-GB (EUCTR) | 25/11/2011 | 21/09/2011 | A 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 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Hungary;Czech Republic;Spain;Germany;United Kingdom | ||
| 85 | NCT01457807 (ClinicalTrials.gov) | November 2011 | 10/10/2011 | To Assess the Effect of Administration of 2 Formulation of AZD3241 on Blood Concentration in Healthy Volunteers | A 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 Volunteers | Parkinson's Disease | Drug: AZD3241 ER formulation 1;Drug: Placebo;Drug: AZD3241 Alternative titration scheme with formulation 1 or 2 | AstraZeneca | NULL | Completed | 30 Years | 65 Years | Both | 24 | Phase 1 | United Kingdom |
| 86 | NCT01439100 (ClinicalTrials.gov) | October 2011 | 21/9/2011 | A Randomised Placebo Controlled Study of OXN PR for Severe Parkinson's Disease Associated Pain | Parkinson's Disease With Severe Pain | Drug: Oxycodone/Naloxone Prolonged Release tablets;Drug: Placebo | Mundipharma Research GmbH & Co KG | NULL | Completed | 25 Years | N/A | Both | 172 | Phase 3 | Czech Republic;Germany;Hungary;Poland;Romania;Spain;United Kingdom | |
| 87 | NCT02170376 (ClinicalTrials.gov) | September 2011 | 19/6/2014 | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics | The Effect of BIA 9-1067 at Steady-state on the Levodopa Pharmacokinetics When Administered With Immediate-release 100/25 mg Levodopa/Carbidopa in Healthy Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Entacapone;Drug: Placebo;Drug: Levodopa/carbidopa | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 80 | Phase 1 | France |
| 88 | NCT01411137 (ClinicalTrials.gov) | August 2011 | 4/8/2011 | Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study | An 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 PD | Parkinson's Disease | Drug: IPX066 | Impax Laboratories, LLC | Michael J. Fox Foundation for Parkinson's Research | Completed | 30 Years | N/A | All | 43 | Phase 3 | United States |
| 89 | NCT01397422 (ClinicalTrials.gov) | July 2011 | 18/7/2011 | Extended 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 Disease | Drug: ADS-5102 (extended release amantadine HCl) | Adamas Pharmaceuticals, Inc. | NULL | Completed | 30 Years | 85 Years | All | 83 | Phase 2/Phase 3 | United States |
| 90 | NCT01191944 (ClinicalTrials.gov) | August 2010 | 30/8/2010 | Pramipexole Extended Release Versus Pramipexole Immediate Release for 18 Weeks in Chinese Parkinson's Disease (PD) Patients | A 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 Levodopa | Parkinson Disease | Drug: pramipexole immediate release tablet;Drug: pramipexole extended release tablet | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 475 | Phase 3 | China |
| 91 | NCT01097421 (ClinicalTrials.gov) | March 2010 | 25/3/2010 | Influence of Pramipexole Extended Release on Medication Adherence in Parkinson´s Disease | Influence of Pramipexole Extended Release on Medication Adherence in Real Life Care of Parkinson's Disease | Parkinson Disease | Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 329 | N/A | Sweden |
| 92 | NCT01568047 (ClinicalTrials.gov) | February 2010 | 29/3/2012 | Multicentre Study in Four Parallel Groups of Parkinson's Disease (PD) Patients | Multicentre, 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 Disease | Drug: Placebo;Drug: BIA 9-1067;Drug: Levodopa/Carbidopa;Drug: Levodopa/Benzerazide | Bial - Portela C S.A. | NULL | Completed | 30 Years | N/A | All | 40 | Phase 2 | Romania;Ukraine |
| 93 | NCT02169414 (ClinicalTrials.gov) | February 2010 | 24/1/2012 | Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics | Effect 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 Subjects | Parkinson'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 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 74 | Phase 1 | France |
| 94 | NCT00660387 (ClinicalTrials.gov) | December 2009 | 15/4/2008 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A 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 Fluctuations | Advanced Parkinson's Disease | Drug: 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-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 35 | Phase 3 | United States;New Zealand |
| 95 | EUCTR2009-013004-31-IT (EUCTR) | 02/11/2009 | 02/11/2009 | Early 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 | Early 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 PARMA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 96 | NCT01371682 (ClinicalTrials.gov) | September 18, 2009 | 10/6/2010 | A Study Conducted in Healthy Subjects to Demonstrate Bioequivalence Between Ropinirole Prolonged Release Tablets Manufactured at Crawley and Aranda | An 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 Aranda | Parkinson Disease | Drug: Ropinirole XL | GlaxoSmithKline | NULL | Completed | 18 Years | 50 Years | All | 50 | Phase 1 | Belgium |
| 97 | NCT00986245 (ClinicalTrials.gov) | September 2009 | 24/9/2009 | Study to Compare the Effect of Ropinirole Prolonged Release Once-daily Versus Twice-daily | An Open-label, Multi-center, Crossover Study to Compare the Effect of Once-daily Ropinirole PR and Twice-daily Ropinirole PR in Patients With Parkinson Disease | Parkinson Disease | Drug: Ropinirole Prolonged release | Seoul National University Hospital | NULL | Completed | 30 Years | 80 Years | All | 82 | Phase 4 | Korea, Republic of |
| 98 | NCT00918177 (ClinicalTrials.gov) | July 2009 | 1/6/2009 | An Evaluation of the Pharmacokinetics and Pharmacodynamics of AP09004 in Patients With Parkinson's Disease | Dual Release Gastric Retentive AP09004, Vs. Active Control; a Pharmacokinetic/Pharmacodynamic, Comparative, Safety Evaluation in Parkinson's Patients | Parkinson's Disease | Drug: AP09004;Drug: Carbidopa/Levodopa, immediate release | Intec Pharma Ltd. | NULL | Completed | 18 Years | N/A | Both | 72 | Phase 2 | Israel |
| 99 | EUCTR2007-004234-16-AT (EUCTR) | 14/04/2009 | 10/03/2008 | Long-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 KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 100 | EUCTR2007-004235-37-AT (EUCTR) | 02/04/2009 | 10/03/2008 | 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 | 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 RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 101 | NCT01533077 (ClinicalTrials.gov) | March 2009 | 24/1/2012 | Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa | Pharmacokinetic Interaction Between BIA 9-1067 and Standard-release Levodopa/Carbidopa in Healthy Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Sinemet® 100/25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 18 | Phase 1 | Canada |
| 102 | NCT01533116 (ClinicalTrials.gov) | March 2009 | 24/1/2012 | Effect of BIA 9-1067 at Steady-state on the Pharmacokinetics of Levodopa/Carbidopa and Levodopa/Benserazide | Effect 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 Subjects | Parkinson Disease | Drug: BIA 9-1067;Drug: Placebo;Drug: levodopa/carbidopa;Drug: levodopa/benserazide | Bial - Portela C S.A. | NULL | Completed | 25 Years | 45 Years | All | 52 | Phase 1 | Canada |
| 103 | NCT00823836 (ClinicalTrials.gov) | March 2009 | 15/1/2009 | Clinical Evaluation of Ropinirole Prolonged Release/Extended Release (PR/XR) Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease | Clinical Evaluation of Ropinirole PR/XR Tablet for Adjunctive Therapy to L-dopa in Subjects With Advanced Parkinson's Disease | Parkinson Disease | Drug: ropinirole PR/XR;Drug: ropinirole IR | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 302 | Phase 3 | Japan |
| 104 | EUCTR2009-015833-66-IT (EUCTR) | 20/01/2009 | 18/04/2012 | Ropinirole 24h prolonged release and motor fluctuations: a study to control the wearing-off induced by dopamine agonists immediate release | Ropinirole 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 - PISANA | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 105 | NCT00357994 (ClinicalTrials.gov) | January 2009 | 27/7/2006 | Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects | A 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 Fluctuations | Advanced Parkinson's Disease | Drug: 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-tube | AbbVie (prior sponsor, Abbott) | Quintiles, Inc. | Completed | 30 Years | N/A | All | 36 | Phase 3 | United States;Germany |
| 106 | NCT02169466 (ClinicalTrials.gov) | January 2009 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide | Pharmacokinetic-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 Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Madopar® HBS | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 22 | Phase 1 | Portugal |
| 107 | EUCTR2007-004235-37-IT (EUCTR) | 02/10/2008 | 28/11/2007 | Long-term safety study of open-label pramipexole extended release (ER) in patients with advanced Parkinson?s disease (PD). - ND | Long-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. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 108 | NCT02169453 (ClinicalTrials.gov) | October 2008 | 20/1/2012 | Pharmacokinetic-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 | Pharmacokinetic-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 Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® CR 100/25 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 12 | Phase 1 | Canada |
| 109 | NCT02169479 (ClinicalTrials.gov) | September 2008 | 20/1/2012 | Pharmacokinetic-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 | Pharmacokinetic-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 Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Sinemet® 100/25 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Male | 16 | Phase 1 | Canada |
| 110 | NCT02169895 (ClinicalTrials.gov) | September 2008 | 20/1/2012 | Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Immediate-release Levodopa/Benserazide | Pharmacokinetic-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 Subjects | Parkinson's Disease (PD) | Drug: BIA 9-1067;Drug: Placebo;Drug: Prolopa® | Bial - Portela C S.A. | NULL | Completed | 25 Years | 45 Years | Male | 16 | Phase 1 | Canada |
| 111 | EUCTR2007-004235-37-GB (EUCTR) | 19/08/2008 | 26/11/2007 | 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 | 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 | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 112 | NCT00601978 (ClinicalTrials.gov) | August 2008 | 11/1/2008 | Carbidopa/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 Off | A 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 Off | Parkinson's Disease | Drug: carbidopa/levodopa;Drug: Carbidopa/Levodopa/Entacapone | Novartis Pharmaceuticals | NULL | Withdrawn | 45 Years | 75 Years | Both | 0 | Phase 4 | United States |
| 113 | EUCTR2007-003134-42-DE (EUCTR) | 19/06/2008 | 20/02/2008 | 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. | 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 20 | Germany | |||
| 114 | EUCTR2007-004235-37-PL (EUCTR) | 29/05/2008 | 16/04/2008 | 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 | 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Austria;Poland;Sweden | |||
| 115 | EUCTR2007-004235-37-SE (EUCTR) | 23/04/2008 | 25/03/2008 | 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 | 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 AB | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;Czech Republic;United Kingdom;Spain;Italy;Poland;Austria;Sweden | |||
| 116 | EUCTR2007-004234-16-FI (EUCTR) | 16/04/2008 | 12/02/2008 | Long-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 Ky | NULL | Not Recruiting | Female: yes Male: yes | 520 | Hungary;Finland;Czech Republic;Netherlands;France;Austria | |||
| 117 | NCT00651183 (ClinicalTrials.gov) | April 2008 | 31/3/2008 | Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment | Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment | Parkinson Disease | Drug: Pramipexole immediate release | Boehringer Ingelheim | NULL | Completed | 18 Years | N/A | All | 286 | Austria | |
| 118 | EUCTR2007-005033-11-DE (EUCTR) | 27/03/2008 | 04/01/2008 | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | A Comparison Of The Safety And Bioavailability Of Modified-Release Formulations Of Levodopa-Carbidopa In Subjects With Parkinson’s Disease | Patients with Parkinson's Disease | Product 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, Inc | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 119 | EUCTR2007-004235-37-HU (EUCTR) | 17/03/2008 | 17/01/2008 | 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 | 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Czech Republic;Hungary;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 120 | EUCTR2007-004234-16-HU (EUCTR) | 17/03/2008 | 17/01/2008 | Long-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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 121 | NCT00642356 (ClinicalTrials.gov) | March 2008 | 19/3/2008 | Carbidopa/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 Off | An 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 Off | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis | NULL | Terminated | 30 Years | 85 Years | All | 14 | Phase 4 | United States |
| 122 | EUCTR2007-004235-37-ES (EUCTR) | 24/01/2008 | 08/03/2010 | Long-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 | Long-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. | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Poland;Spain;Austria;Italy;United Kingdom;Sweden | ||
| 123 | EUCTR2007-004235-37-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | 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 | 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 390 | Hungary;United Kingdom;Czech Republic;Spain;Italy;Poland;Austria;Sweden | |||
| 124 | EUCTR2007-004234-16-CZ (EUCTR) | 21/01/2008 | 18/12/2007 | Long-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 KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 125 | EUCTR2007-004235-37-SK (EUCTR) | 14/01/2008 | 16/04/2008 | 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 | 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 RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 390 | Phase 3 | Hungary;Czech Republic;Slovakia;Spain;Poland;Austria;Italy;United Kingdom;Sweden | ||
| 126 | EUCTR2007-004234-16-SK (EUCTR) | 14/01/2008 | 18/04/2008 | Long-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 KG | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
| 127 | EUCTR2007-004234-16-FR (EUCTR) | 11/01/2008 | 19/11/2007 | Long-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 | NULL | Not Recruiting | Female: yes Male: yes | 520 | Phase 3 | France;Hungary;Czech Republic;Slovakia;Finland;Austria;Netherlands | ||
| 128 | NCT00601523 (ClinicalTrials.gov) | January 2008 | 15/1/2008 | Long-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 Disease | Drug: Placebo;Drug: Pramipexole | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 511 | Phase 3 | United States;Austria;Czech Republic;Finland;France;Germany;Hungary;India;Japan;Malaysia;Netherlands;Russian Federation;Slovakia;Taiwan;Ukraine;Argentina |
| 129 | NCT00577460 (ClinicalTrials.gov) | December 2007 | 19/12/2007 | Long-term Safety Study of Open-label Pramipexole ER in Patients With Advanced PD | Long-term Safety Study of Open-label Pramipexole Extended Release (ER) in Patients With Advanced Parkinson's Disease (PD) | Parkinson Disease | Drug: Pramipexole;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 391 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 130 | NCT00560508 (ClinicalTrials.gov) | November 2007 | 16/11/2007 | A 12-week Study of Pramipexole Extended Release (ER) in Patients With Parkinson's Disease (PD), Followed by a 52-week Long-term Treatment Period | A 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 ER | Parkinson Disease | Drug: Pramipexole Immediate Release;Drug: Pramipexole Extended Release | Boehringer Ingelheim | NULL | Completed | 1 Year | N/A | All | 112 | Phase 2/Phase 3 | Japan |
| 131 | NCT00558337 (ClinicalTrials.gov) | November 2007 | 12/11/2007 | Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Study of L-Dopa/Carbidopa To Treat Parkinson's Disease | An Efficacy, Safety, and Pharmacokinetics/Pharmacodynamic Relationship Study of L-Dopa/Carbidopa in a Novel Release Formulation in Parkinson's Disease Patients | Parkinson's Disease | Drug: levodopa-carbidopa | Osmotica Pharmaceutical Corp. | NULL | Completed | 30 Years | 80 Years | Both | 78 | Phase 2 | Argentina |
| 132 | EUCTR2007-004234-16-NL (EUCTR) | 29/10/2007 | 17/10/2007 | Long-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 bv | NULL | Not Recruiting | Female: yes Male: yes | 520 | Finland;Hungary;Czech Republic;Netherlands;France;Austria | |||
| 133 | NCT00558025 (ClinicalTrials.gov) | October 2007 | 12/11/2007 | Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease | A 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 IR | Parkinson Disease | Drug: Pramipexole Extended Release;Drug: Pramipexole Immediate Release | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 156 | Phase 3 | France;Germany;Netherlands |
| 134 | EUCTR2007-000073-39-CZ (EUCTR) | 18/06/2007 | 18/04/2007 | 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) | 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 KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 135 | EUCTR2007-000073-39-HU (EUCTR) | 14/06/2007 | 31/05/2007 | 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) | 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Finland;Hungary;Czech Republic;Austria | ||
| 136 | EUCTR2007-000073-39-SK (EUCTR) | 14/06/2007 | 09/04/2008 | 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) | 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Czech Republic;Slovakia;Finland;Austria;Germany | ||
| 137 | NCT00460954 (ClinicalTrials.gov) | June 2007 | 16/4/2007 | A Multiple-Dose Study of Sinemet® CR (Carbidopa/Levodopa) in Healthy Subjects | An Open Label, Multiple-Dose Study ot Determine the Plasma Levodopa Profiles of Sinemet® CR (Carbidopa/Levodopa) at 4 Daily Dose Levels in Healthy Subjects | Parkinson's Disease | Drug: Sinemet® controlled release (Carbidopa/levodopa) | Bristol-Myers Squibb | NULL | Completed | 50 Years | 75 Years | Both | 20 | N/A | Canada |
| 138 | EUCTR2007-000073-39-AT (EUCTR) | 30/05/2007 | 05/06/2007 | 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) | 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 mbH | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 139 | EUCTR2007-000073-39-DE (EUCTR) | 29/05/2007 | 26/02/2007 | 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) | 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. KG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Czech Republic;Finland;Austria;Germany | ||
| 140 | NCT00479401 (ClinicalTrials.gov) | May 2007 | 25/5/2007 | Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients | 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 Parkinsons Disease (PD). | Early Parkinson Disease (Early PD) | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 539 | Phase 3 | United States;Argentina;Austria;Czech Republic;Finland;Germany;Hungary;India;Japan;Malaysia;Russian Federation;Slovakia;Taiwan;Ukraine;Brazil |
| 141 | EUCTR2007-000073-39-FI (EUCTR) | 25/04/2007 | 06/03/2007 | 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) | 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 Ky | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 1 | Hungary;Finland;Czech Republic;Austria | ||
| 142 | NCT00434304 (ClinicalTrials.gov) | April 9, 2007 | 9/2/2007 | Clinical 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 Disease | Drug: Ropinirole prolonged release/extended release(PR/XR) | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 62 | Phase 2 | Japan |
| 143 | NCT00466167 (ClinicalTrials.gov) | April 2007 | 25/4/2007 | Pivotal Study in Advanced Parkinsons Disease Patients | A 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 Disease | Drug: Pramipexol Extended Release;Drug: Pramipexol Immediate Release;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 32 Years | N/A | All | 517 | Phase 3 | Austria;Czech Republic;Hungary;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Slovakia;Spain;Sweden;Ukraine;United Kingdom |
| 144 | NCT00460148 (ClinicalTrials.gov) | April 2007 | 11/4/2007 | Parkinson's Disease Patient Study On Absorption, Distribution, Metabolism And Excretion Of Ropinirole | 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 Disease | Drug: Ropinirole | GlaxoSmithKline | NULL | Completed | 30 Years | 85 Years | Both | 28 | Phase 2 | Germany;South Africa |
| 145 | EUCTR2006-006209-94-DE (EUCTR) | 15/03/2007 | 26/01/2007 | 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. | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 36 | Germany | |||
| 146 | NCT00465452 (ClinicalTrials.gov) | January 2007 | 24/4/2007 | Impact of Switching to Continuous Release Dopamine Agonists | The Impact of Switching to Continuous Release Dopamine Agonists on Non-Motor Side Effects | Parkinson Disease | Drug: Continuous Release Dopamine Agonists | University of Toledo Health Science Campus | NULL | Completed | 55 Years | N/A | Both | 15 | Phase 3 | United States |
| 147 | EUCTR2005-005423-34-HU (EUCTR) | 04/09/2006 | 05/07/2006 | 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. | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
| 148 | NCT00331149 (ClinicalTrials.gov) | June 20, 2006 | 26/5/2006 | A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's | A 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 Disease | Drug: Ropinirole prolonged release;Drug: ropinirole immediate release | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 343 | Phase 3 | Bulgaria;Canada;Czechia;France;Germany;Hungary;Italy;Poland;Romania;Russian Federation;South Africa;Spain;Ukraine;United Kingdom;Czech Republic |
| 149 | EUCTR2005-005423-34-DE (EUCTR) | 19/06/2006 | 02/03/2006 | 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. | 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 | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
| 150 | EUCTR2005-005423-34-ES (EUCTR) | 19/05/2006 | 29/03/2006 | 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. | 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 | 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 | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 516 | Phase 3 | Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 151 | EUCTR2005-005423-34-GB (EUCTR) | 11/05/2006 | 17/03/2006 | 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. | 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 | 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 | GlaxoSmithKline Research & Development Ltd | NULL | Not 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): no | Hungary;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 152 | EUCTR2005-005423-34-IT (EUCTR) | 08/05/2006 | 03/10/2006 | 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. - ND | 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. - 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 D | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Czech Republic;Germany;Spain;Italy | |||
| 153 | EUCTR2005-005423-34-CZ (EUCTR) | 20/04/2006 | 03/03/2006 | 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. | 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 | 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 516 | Hungary;United Kingdom;Germany;Czech Republic;Spain;Italy | |||
| 154 | EUCTR2005-001032-72-PT (EUCTR) | 23/03/2006 | 11/11/2005 | 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 Parkinson's disease patients requiring levodopa. - First Step | 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 Parkinson's disease patients requiring levodopa. - First Step | Parkinson disease | Trade 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 155 | EUCTR2005-001032-72-CZ (EUCTR) | 16/02/2006 | 12/01/2006 | 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 Parkinson's disease patients requiring levodopa. - First Step | 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 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | ||||
| 156 | NCT00275275 (ClinicalTrials.gov) | January 2006 | 9/1/2006 | Pramipexole 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 Disease | Drug: Requip PR;Drug: Mirapex | Rajesh Pahwa, MD | GlaxoSmithKline | Completed | 18 Years | N/A | All | 61 | Phase 3 | United States |
| 157 | EUCTR2005-001032-72-IT (EUCTR) | 25/11/2005 | 26/03/2007 | 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. | 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 FARMA | NULL | Not Recruiting | Female: yes Male: yes | 424 | Portugal;Czech Republic;Italy | |||
| 158 | NCT00253084 (ClinicalTrials.gov) | November 2005 | 11/11/2005 | Comparison of IPX054 and Immediate-Release Carbidopa-Levodopa in Patients With Parkinson's Disease | A Randomized, Double-Blind, Cross-Over Study to Compare IPX054 to Carbidopa-Levodopa Immediate-Release Tablets in Subjects With Parkinson's Disease | Parkinson's Disease | Drug: IPX054 200 mg;Drug: CD-LD IR;Drug: IPX054 Placebo;Drug: CD-LD IR Placebo | Impax Laboratories, LLC | NULL | Completed | 30 Years | N/A | All | 12 | Phase 2 | United States |
| 159 | NCT02778594 (ClinicalTrials.gov) | September 2005 | 18/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide | Pharmacokinetic-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 Volunteers | Parkinson's Disease (PD) | Drug: BIA 3-202;Drug: Placebo;Drug: levodopa 100 mg / benserazide 25 mg | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 17 | Phase 1 | Portugal |
| 160 | NCT02774564 (ClinicalTrials.gov) | September 2005 | 13/5/2016 | Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Carbidopa | Pharmacokinetic-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 Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Sinemet® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 16 | Phase 1 | Portugal |
| 161 | NCT00134966 (ClinicalTrials.gov) | August 2005 | 23/8/2005 | A Study to Evaluate Fixed Dose Carbidopa/Levodopa/Entacapone Versus Immediate Release Carbidopa/Levodopa | A 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 Levodopa | Parkinson's Disease | Drug: capsules containing: carbidopa (25 mg), levodopa (100 mg), entacapone (200 mg) | Novartis | NULL | Completed | 30 Years | 80 Years | All | 493 | Phase 3 | United States;Canada;Czechia;Israel;Italy;Poland;Portugal;Turkey;Czech Republic |
| 162 | NCT00144300 (ClinicalTrials.gov) | January 2005 | 2/9/2005 | Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients | A Two Year Open Label, Randomized, Parallel Group, Blinded Assessment Ophthalmologic Safety Study of Pramipexole IR Versus Ropinirole in Early Parkinson's Disease Patients | Parkinson Disease | Drug: Mirapex;Drug: Requip | Boehringer Ingelheim | NULL | Completed | 30 Years | N/A | All | 246 | Phase 4 | United States |
| 163 | NCT00099268 (ClinicalTrials.gov) | September 2004 | 10/12/2004 | Efficacy and Safety of Carbidopa/Levodopa/Entacapone in Patients With Parkinson's Disease Requiring Initiation of Levodopa Therapy | A 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 Therapy | Parkinson's Disease | Drug: Carbidopa/levodopa/entacapone;Drug: Immediate release carbidopa/levodopa | Novartis Pharmaceuticals | Orion Corporation, Orion Pharma | Completed | 30 Years | 70 Years | All | 747 | Phase 3 | United States;Austria;Belgium;Canada;Finland;France;Germany;Greece;Italy;Spain;Sweden;Switzerland;Turkey;United Kingdom |
| 164 | NCT00174239 (ClinicalTrials.gov) | July 2004 | 9/9/2005 | Study 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 Disease | Drug: cabergoline;Drug: controlled-release levodopa / carbidopa | Pfizer | NULL | Terminated | 18 Years | 80 Years | Both | 220 | Phase 4 | Australia;Italy;Spain;United Kingdom |
| 165 | NCT00632736 (ClinicalTrials.gov) | February 2004 | 4/3/2008 | An Open-label Continuation Study Evaluating the Long-term Safety of Extended Release Ropinirole XL (Formerly CR) in Parkinson''s Disease | An Open-Label Extension Study With REQUIP (Ropinirole) CR for Subjects From Studies 101468/165, 101468/168 and 101468/169 | Parkinson Disease;Parkinson's Disease | Drug: Ropinirole XL (formerly CR) | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 419 | Phase 3 | United States;Belgium;Czech Republic;France;Hungary;Italy;Poland;Spain;United Kingdom;Germany;Philippines |
| 166 | NCT00363727 (ClinicalTrials.gov) | December 2003 | 7/8/2006 | Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's | A 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;Dyskinesias | Drug: ropinirole controlled-release (REQUIP CR) for RLS | GlaxoSmithKline | NULL | Completed | 30 Years | 70 Years | All | 209 | Phase 3 | United States |
| 167 | NCT00650104 (ClinicalTrials.gov) | May 2002 | 27/3/2008 | Long-term Extension Study Evaluating Extended Release Ropinirole XL (Formerly Referred to as Ropinirole CR) in Patients Who Already Completed Either Study 167 or 164 | 101648/196: 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 164 | Parkinson Disease | Drug: Ropinirole XL (formerly CR) | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 76 | Phase 3 | United States;Belgium;France;Netherlands;Norway |