6. パーキンソン病 Parkinson disease Clinical trials / Disease details
臨床試験数 : 2,298 / 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
| 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 | 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 | ||
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | NCT00914602 (ClinicalTrials.gov) | May 2009 | 3/6/2009 | An Exploratory Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects | An Exploratory Pharmacokinetic, Pharmacodynamic and Safety Study of XP21279 (With Lodosyn®) and Sinemet® in Parkinson's Disease Subjects With Motor Fluctuations | Parkinson's Disease | Drug: Sinemet 25-100 Oral Tablet;Drug: XP21279;Drug: Carbidopa Pill | XenoPort, Inc. | NULL | Completed | 30 Years | 75 Years | All | 14 | Phase 1/Phase 2 | United States |