SPM 962
( DrugBank: - / KEGG DRUG: - )
1 disease
告示番号 | 疾患名(ページ内リンク) | 臨床試験数 |
---|---|---|
6 | パーキンソン病 | 24 |
6. パーキンソン病
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
Showing 1 to 10 of 24 trials
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 |
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1 | NCT01631825 (ClinicalTrials.gov) | October 200920091000 | 25/6/201220120625 | A Long-Term Extension Trial From of SPM 962 in Advanced Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa An Open-label Long-term Extension Trial From Phase III of SPM962 (243-08-002) in Advanced Parkinson' ... | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 321 | Phase 3 | Japan |
2 | NCT01628926 (ClinicalTrials.gov) | June 200920090600 | 24/6/201220120624 | A Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients | A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa A Double-Blind, 3-Arm, Parallel Group, Placebo- and Ropinirole-Controlled Study for SPM 962in Advanc ... | Parkinson's Disease | Drug: SPM 962;Drug: Ropinirole;Drug: Placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 420 | Phase 3 | Japan |
3 | JPRN-JapicCTI-090888 | 01/4/200920090401 | 00000000 | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962in Subjects ... | A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962 in Subjects with Parkinson's Disease Treated Concomitantly with L-dopa A Double-Blind, 3-Arm, Parallel Group, Placebo-and Ropinirole-Controlled Study of SPM 962in Subjects ... | Parkinson's Disease Treated Concomitantly with L-dopa | Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal application, 1 time per day. Initial dose:4.5mg/day, weekly increment of 4.5mg/day, maximal maintenance dose : 36.0mg/day. Placebo of ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day Control intervention name : Ropinirole Dosage And administration of the control intervention : placebo SPM 962: transdermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Ropinirole: oral application 3 times per day. Initial dose:0.75mg/day, weekly increment of 0.75mg/day (up to 3.0mg/day), then 1.5mg/day (up to 15.0mg/day), maximal maintenance dose 15.0 mg/day. Control intervention name : Placebo Dosage And administration of the control intervention : placebo SPM 962: transermal application, 1 time per day. Initial dose: 4.5mg placebo/day, weekly increment of 4.5mg placebo/day, maximal maintenance dose : 36.0mg placebo/day. Placebo ropinirole: oral application 3 times per day. Initial dose:0.75mg placebo/day, weekly increment of 0.75mg placebo/day (up to 3.0mg placebo/day), then 1.5mg placebo/day (up to 15.0mg placebo/day), maximal maintenance dose 15.0 mg placebo/day. Intervention name : SPM 962 Dosage And administration of the intervention : SPM 962: transdermal appl ... | Otsuka Pharmaceutical Co., Ltd. | NULL | 30 | 79 | BOTH | 400 | Phase 3 | NULL | |
4 | EUCTR2004-000148-26-AT (EUCTR) | 31/12/200820081231 | 26/11/200820081126 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term ... | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term ... | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: ... | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Czech Republic;Hungary;Finland;Spain;Austria;Italy;Sweden | ||
5 | EUCTR2004-000148-26-HU (EUCTR) | 26/07/200820080726 | 19/07/200420040719 | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term ... | A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term treatment of rotigotine patch in subjects with advanced stage, idiopathic Parkinson's disease who are not well controlled on levodopa - N/A A multi-centre, multinational, phase 3, open-label extension trial to assess the safety of long-term ... | Parkinson's Disease | Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: (6S)-6-{propyl-[2-[2-thienyl]ethyl]amino}-5,6,7,8-tetrahydro-1-naphtalenol Product Name: Rotigotine Product Code: SPM 962 INN or Proposed INN: Rotigotine Other descriptive name: ... | Schwarz BioSciences Inc. | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Finland;Hungary;Czech Republic;Spain;Italy;Sweden | ||
6 | NCT01628965 (ClinicalTrials.gov) | January 200820080100 | 25/6/201220120625 | A Long-Term Extension Trial From Phase II/III of SPM 962 in Early Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa An Open-label Long-term Extension Trial From Phase II/III of SPM962 (243-07-001) in Early Parkinson' ... | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 143 | Phase 2/Phase 3 | Japan |
7 | EUCTR2006-006907-35-IT (EUCTR) | 19/12/200720071219 | 20/04/200720070420 | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect ... | A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect of the 24 hour transdermal delivery of rotigotine on motor function, sleep quality, and nocturnal and non motor symptoms in subjects with idiopathic Parkinson disease. - SP915, Long term extension of RECOVER A multicenter, multinational, phase 3b, open label extension trial, to evaluate the long term effect ... | Patient with Idiopathic Parkinson Diesease MedDRA version: 9.1;Level: LLT;Classification code 10061536;Term: Parkinson's disease Patient with Idiopathic Parkinson Diesease MedDRA version: 9.1;Level: LLT;Classification code 100615 ... | Product Name: rotigotine INN or Proposed INN: rotigotine | SCHWARZ PHARMA | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | Hungary;Finland;United Kingdom;Germany;Spain;Italy;Austria | ||
8 | NCT00537485 (ClinicalTrials.gov) | September 200720070900 | 27/9/200720070927 | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients | A Placebo-controlled Study for SPM 962 in Early Parkinson's Disease Patients With Non-concomitant Treatment of L-dopa A Placebo-controlled Study for SPM 962in Early Parkinson's Disease Patients With Non-concomitant Tre ... | Early Parkinson's Disease | Drug: SPM 962;Drug: placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 180 | Phase 2/Phase 3 | Japan |
9 | NCT01631812 (ClinicalTrials.gov) | December 200620061200 | 25/6/201220120625 | A Long-Term Extension Trial From Late Phase II of SPM 962 in Advanced Parkinson's Disease Patients | An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa An Open-label Long-term Extension Trial From Late Phase II of SPM962 (243-05-001) in Advanced Parkin ... | Parkinson's Disease | Drug: SPM 962 | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | N/A | N/A | All | 130 | Phase 2 | Japan |
10 | NCT01628848 (ClinicalTrials.gov) | August 200620060800 | 24/6/201220120624 | A Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients | A Placebo-controlled Dose-finding Study for SPM 962 in Advanced Parkinson's Disease Patients With Concomitant Treatment of L-dopa A Placebo-controlled Dose-finding Study for SPM 962in Advanced Parkinson's Disease Patients With Con ... | Parkinson's Disease | Drug: SPM 962;Drug: Placebo | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 30 Years | 79 Years | All | 174 | Phase 2 | Japan |