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 | 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 | |||
| 2 | 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 | |||
| 3 | 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 | |||
| 4 | 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 | ||
| 5 | NCT01536574 (ClinicalTrials.gov) | September 2, 2010 | 19/1/2012 | Open-Label Extension Study With REQUIP PR for Subjects From Study ROP111528 | An Open Label Extension Study With REQUIP PR for Subjects From Study ROP111528 | Parkinson Disease | Drug: Requip PR | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 295 | Phase 3 | China |
| 6 | NCT01154166 (ClinicalTrials.gov) | February 15, 2010 | 29/6/2010 | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel Group Study of Six Months Treatment With Ropinirole PR as Adjunctive Therapy in Patients With Parkinson's Disease Who Are Not Optimally Controlled on L-Dopa | Parkinson Disease | Drug: ReQuip PR;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 30 Years | N/A | All | 347 | Phase 3 | China |
| 7 | 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 |
| 8 | EUCTR2009-012529-12-FR (EUCTR) | 10/06/2009 | 18/05/2009 | A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP | A randomised, REQUIP® IR-controlled, n-of-1, multiple crossover, pilot trial of the effect of REQUIP®CR on abnormal daytime somnolence in patients with Parkinson’s Disease - REQUIP | parkinson's disease MedDRA version: 9.1;Level: LLT;Classification code 10013113;Term: Disease Parkinson's | Trade Name: REQUIP-LP Product Name: ropinirole Trade Name: REQUIP Product Name: ropinirole | CHU de Toulouse | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 10 | France | |||
| 9 | 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 | ||||
| 10 | NCT00485069 (ClinicalTrials.gov) | June 2007 | 11/6/2007 | REQUIP (Ropinirole Hydrochloride) IR Long-Term Phase 4 Study | Post-Marketing Clinical Study of REQUIP (Ropinirole Hydrochloride) Tablets in Patients With Parkinson's Disease- Evaluation of Long-Term Efficacy and Safety - | Parkinson Disease;Parkinson's Disease | Drug: ROP;Drug: ROP+L-Dopa | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 123 | Phase 4 | Japan |
| 11 | 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 | |||
| 12 | NCT00399477 (ClinicalTrials.gov) | October 2006 | 10/11/2006 | A Non-Blinded Study Demonstrating the Effectiveness and Safety of Azilect Alone or in Combination Therapy in Parkinson's Disease | Open-label, Multicenter, Effectiveness and Safety Study of Once Daily AZILECT® as Mono- or Adjunct Therapy in Patients With Idiopathic Parkinson's Disease (PD) | Parkinson's Disease | Drug: rasagiline mesylate;Drug: Rasagiline mesylate plus Mirapex;Drug: Rasagiline mesylate with Levodopa;Drug: Rasagiline mesylate with Requip | Teva Neuroscience, Inc. | NULL | Completed | 30 Years | N/A | Both | 200 | Phase 4 | United States |
| 13 | 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 |
| 14 | 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 | |||
| 15 | 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 |
| 16 | NCT00260793 (ClinicalTrials.gov) | November 2005 | 1/12/2005 | Open Label High Dose Ropinirole (Requip) Study for Patients With Parkinson's Disease | Open Label Prospective Study of High Dose Ropinirole for Motor Fluctuations and Dyskinesias in Advanced Parkinson's Disease | Parkinson's Disease | Drug: Ropinirole Hydrochloride | Agarwal, Pinky, M.D. | Colorado Neurology;GlaxoSmithKline | Recruiting | 25 Years | N/A | Both | 20 | Phase 3 | United States |
| 17 | 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 |
| 18 | EUCTR2004-002609-66-IT (EUCTR) | 21/12/2004 | 03/03/2006 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson s disease | Idiopathic Parkinson Disease in early stage MedDRA version: 6.1;Level: PT;Classification code 10061536 | Product Name: rotigotine Product Code: SPM 926 Trade Name: REQUIP 21 CPR 0,25 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 0,5 MG INN or Proposed INN: Ropinirole Product Name: rotigotine Product Code: SPM 962 Product Name: rotigotine Product Code: SPM 962 Trade Name: REQUIP 21 CPR 1 MG INN or Proposed INN: Ropinirole Trade Name: REQUIP 21 CPR 2 MG INN or Proposed INN: Ropinirole | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 19 | EUCTR2004-002609-66-DE (EUCTR) | 06/12/2004 | 22/04/2005 | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | A phase 3, randomized, open-label, two-arm, parallel-group, multicenter, multinational trial to compare the efficacy of rotigotine transdermal patch to that of ropinirole on early morning motor impairment and sleep disorders in subjects with early-stage, idiopathic Parkinson's disease | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Product Name: Rotigotine Product Code: SPM962 INN or Proposed INN: Rotigotine Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole Trade Name: Requip Product Name: Requip INN or Proposed INN: Ropinirole | Schwarz Biosciences GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Germany;Italy | ||
| 20 | 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 |
| 21 | 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 |