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 | ChiCTR2000039201 | 2020-11-15 | 2020-10-21 | Pharmacology of levodopa/carbidopa versus levodopa/benserazide in patients with parkinson's disease | Pharmacology of levodopa/carbidopa versus levodopa/benserazide in patients with parkinson's disease | Parkinson's disease | A:phase I: levodopa/carbidopa; phase II: levodopa/benserazide ;B:phase I: levodopa/benserazide; phase II: levodopa/carbidopa; | The Affiliated Brain Hospital of Nanjing Medical University (Nanjing Brain Hospital) | NULL | Recruiting | 30 | 85 | Both | A:10;B:10; | Phase 4 | China |
| 2 | NCT02769793 (ClinicalTrials.gov) | June 2015 | 9/5/2016 | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in Parkinson's Disease Patients With Delayed ON: a Multicenter Randomized Open-label Cross-over Trial | Parkinson Disease | Drug: Levodopa dispersible;Drug: Levodopa | Seoul National University Hospital | SMG-SNU Boramae Medical Center;Samsung Medical Center | Completed | 31 Years | 80 Years | All | 40 | Phase 4 | Korea, Republic of |
| 3 | 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 |
| 4 | 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 |
| 5 | 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 |
| 6 | 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 |
| 7 | 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 |
| 8 | EUCTR2006-001793-24-PT (EUCTR) | 07/11/2006 | 31/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Trade Name: COMTAN® Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 9 | NCT03103399 (ClinicalTrials.gov) | September 26, 2006 | 28/3/2017 | Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon | A Multicentre, Double-blind, Randomised, Active- and Placebo-controlled Trial to Investigate the Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With Wearingoff Phenomenon Treated With Levodopa/Carbidopa or Levodopa/Benserazide | Parkinson Disease | Drug: Comtan®;Drug: Nebicapone;Drug: Levodopa/DDCI;Drug: Placebo | Bial - Portela C S.A. | NULL | Completed | 30 Years | 80 Years | All | 254 | Phase 2 | NULL |
| 10 | EUCTR2006-001793-24-AT (EUCTR) | 31/07/2006 | 24/07/2006 | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | A MULTICENTRE, DOUBLE-BLIND, RANDOMIZED, ACTIVE- AND PLACEBO-CONTROLLED TRIAL TO INVESTIGATE THE EFFICACY AND TOLERABILITY OF NEBICAPONE IN PARKINSON’S DISEASE PATIENTS WITH WEARING-OFF” PHENOMENON TREATED WITH LEVODOPA/CARBIDOPA OR LEVODOPA/BENSERAZIDE - not available | Patients with idiopathic Parkinson’s disease (PD) and with end-of-dose deterioration (wearing-off) phenomenon although currently treated with levodopa/DDCI. MedDRA version: 7;Level: LLT;Classification code 10061536 | Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Entacapone INN or Proposed INN: Entacapone Product Name: Nebicapone Product Code: BIA 3-202 Product Name: Nebicapone Product Code: BIA 3-202 | BIAL - Portela & Cª, SA | NULL | Not Recruiting | Female: yes Male: yes | 250 | Portugal;Austria | |||
| 11 | NCT03097211 (ClinicalTrials.gov) | July 17, 2006 | 27/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Nebicapone 150 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Nebicapone | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 38 | Phase 1 | Portugal |
| 12 | NCT03094156 (ClinicalTrials.gov) | April 26, 2006 | 23/3/2017 | Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Placebo-controlled, Rising Multiple Dose Study in Healthy Volunteers to Investigate the Effect of BIA 6-512 at Steady-state on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 200/50 mg or With a Single-dose of Levodopa/Benserazide 200/50 mg Plus a Single-dose of Entacapone 200 mg | Parkinson Disease | Drug: Placebo;Drug: BIA 6-512;Drug: Madopar® 250;Drug: Comtan® | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 39 | Phase 1 | Portugal |
| 13 | 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 |
| 14 | NCT03091543 (ClinicalTrials.gov) | May 4, 2004 | 21/3/2017 | Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics | A Double-blind, Randomised, Crossover, Placebo-controlled Study in Healthy Volunteers to Investigate the Tolerability, Safety and Pharmacokinetics of Four Single-doses of BIA 6-512 (Trans-resveratrol) and Their Effect on the Levodopa Pharmacokinetics When Administered in Combination With a Single-dose of Levodopa/Benserazide 100/25 mg | Parkinson Disease | Drug: Madopar® HBS 125;Drug: Placebo;Drug: BIA 6-512 25 mg dose;Drug: BIA 6-512 50 mg dose;Drug: BIA 6-512 100 mg dose;Drug: BIA 6-512 200 mg dose | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | All | 20 | Phase 1 | Portugal |
| 15 | NCT02763852 (ClinicalTrials.gov) | April 2001 | 4/5/2016 | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg) | Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Benserazide (100/25 mg): a Double-blind, Randomised, Crossover, Placebo Controlled Study in Healthy Volunteers | Parkinson's Disease | Drug: BIA 3-202;Drug: Placebo;Drug: Madopar® 125 | Bial - Portela C S.A. | NULL | Completed | 18 Years | 45 Years | Both | 18 | Phase 1 | Portugal |