8. ハンチントン病 Huntington disease Clinical trials / Disease details
臨床試験数 : 229 / 薬物数 : 193 - (DrugBank : 60) / 標的遺伝子数 : 84 - 標的パスウェイ数 : 158
| 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 | EUCTR2009-018123-32-SE (EUCTR) | 30/09/2010 | 10/06/2010 | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | Huntington disease MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden | |||
| 2 | EUCTR2009-018123-32-NL (EUCTR) | 23/08/2010 | 14/04/2010 | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | Huntington disease MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden | |||
| 3 | EUCTR2009-018123-32-IT (EUCTR) | 28/07/2010 | 15/07/2010 | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease(Protocol DIM20EXT) - Horizon-Plus | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease(Protocol DIM20EXT) - Horizon-Plus | Huntington`s Corea MedDRA version: 9.1;Level: LLT;Classification code 10020469 | Product Name: Dimebon INN or Proposed INN: Dimebon dihydrochloride Product Name: Dimebon INN or Proposed INN: Dimebon dihydrochloride | MEDIVATION, INC. | NULL | Not Recruiting | Female: yes Male: yes | 350 | United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden | |||
| 4 | EUCTR2009-018123-32-DE (EUCTR) | 07/06/2010 | 02/03/2010 | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | Huntington disease MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 5 | EUCTR2009-018123-32-GB (EUCTR) | 14/05/2010 | 18/03/2010 | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | Huntington disease MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden | |||
| 6 | EUCTR2009-018123-32-DK (EUCTR) | 23/04/2010 | 16/03/2010 | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-Plus | Huntington disease MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden | |||
| 7 | NCT01085266 (ClinicalTrials.gov) | February 2010 | 10/3/2010 | An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease | HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease | Huntington Disease | Drug: Dimebon (latrepirdine) | Medivation, Inc. | Pfizer;Pfizer | Terminated | 30 Years | N/A | Both | 362 | Phase 3 | NULL |
| 8 | EUCTR2009-011800-44-NL (EUCTR) | 20/01/2010 | 28/09/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | Huntington disease MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden | ||
| 9 | EUCTR2009-011800-44-IT (EUCTR) | 22/12/2009 | 04/11/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease Version 2.0 08 May 2009 - DIM20 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease Version 2.0 08 May 2009 - DIM20 | Patients with Mild-to-Moderate Huntington Disease MedDRA version: 12.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Name: Dimebon INN or Proposed INN: Dimebon dihydrochloride | MEDIVATION, INC. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden | ||
| 10 | EUCTR2009-011800-44-SE (EUCTR) | 14/12/2009 | 23/09/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | Huntington disease MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden | ||
| 11 | EUCTR2009-011800-44-DE (EUCTR) | 07/10/2009 | 06/07/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | Huntington disease MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 12 | EUCTR2009-011800-44-GB (EUCTR) | 07/10/2009 | 05/06/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | Huntington disease MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden | ||
| 13 | NCT00990613 (ClinicalTrials.gov) | October 2009 | 6/10/2009 | A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The Skin | A Phase 1, Fixed Sequence, Cross-Over Study To Investigate The Single Dose Pharmacokinetics Of A Dimebon (Latrepirdine) Transdermal Solution Relative To The Immediate Release Formulation In Older Adults | Alzheimer's Disease;Huntington's Disease | Drug: Dimebon IR;Drug: Dimebon Transdermal | Pfizer | Medivation, Inc. | Completed | 50 Years | 85 Years | Both | 19 | Phase 1 | United States |
| 14 | NCT00975481 (ClinicalTrials.gov) | October 2009 | 10/9/2009 | A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users | A Randomized, Double-Blind, Placebo- And Active-Controlled Single-Dose, Crossover Study To Evaluate The Abuse Potential Of Single Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug Users | Alzheimer's Disease;Huntington's Disease | Drug: dimebon;Drug: placebo;Drug: alprazolam | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | All | 36 | Phase 1 | Canada |
| 15 | NCT00988624 (ClinicalTrials.gov) | October 2009 | 1/10/2009 | A Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine) | A Phase 1, Randomized, Open-Label, Single Dose Cross-Over Study In Healthy Volunteers To Estimate The Pharmacokinetics Of Four Modified-Release Formulations Of Dimebon (Latrepirdine) | Alzheimer's Disease;Huntington Disease | Drug: Dimebon IR Tablet;Drug: Dimebon MR1;Drug: Dimebon MR2;Drug: Dimebon MR3;Drug: Dimebon MR4 | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | Both | 20 | Phase 1 | United States |
| 16 | EUCTR2009-011800-44-DK (EUCTR) | 11/09/2009 | 04/08/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZON | Huntington disease MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride Product Name: Dimebon Product Code: Dimebon INN or Proposed INN: Dimebon dihydrochloride Other descriptive name: Dimebon dihydrochloride | Medivation, Inc | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden | ||
| 17 | NCT00931073 (ClinicalTrials.gov) | July 2009 | 1/7/2009 | A Phase I Study To Estimate The Effect Of Ketoconazole And Omeprazole On The Pharmacokinetics Of Dimebon In Healthy Subjects Who Are Normal Or Poor CYP2D6 Metabolizers | A Phase I, Open-Label, Three-Period, Fixed-Sequence Study To Estimate The Steady-State Effect Of Ketoconazole And Omeprazole On The Single-Dose Pharmacokinetics Of Dimebon [PF-01913539] In Healthy CYP2D6 EM And PM Subjects | Alzheimer's Disease;Huntington's Disease | Drug: Dimebon alone;Drug: Dimebon + Ketoconazole;Drug: Dimebon + Omeprazole | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | United States |
| 18 | NCT00920946 (ClinicalTrials.gov) | July 2009 | 12/6/2009 | A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease | Huntington Disease | Drug: Dimebon;Other: Placebo | Medivation, Inc. | Pfizer;Pfizer | Completed | 30 Years | N/A | Both | 403 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Sweden;United Kingdom |
| 19 | NCT00825084 (ClinicalTrials.gov) | February 2009 | 12/1/2009 | A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects | A Phase 1, Randomized, Subject- And Investigator-Blind, Sponsor-Open, Placebo-Controlled, Parallel-Cohort, Single-Dose Escalation, And Multiple-Dose Titration Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy Subjects | Alzheimer's Disease;Huntington's Disease | Drug: Dimebon | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | Both | 45 | Phase 1 | United States |
| 20 | NCT00827034 (ClinicalTrials.gov) | February 2009 | 20/1/2009 | A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects | A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF 01913539) On The Single-Dose Pharmacokinetics And Pharmacodynamics Of Warfarin In Healthy Subjects | Alzheimer's Disease;Huntington's Disease | Drug: Warfarin;Drug: Dimebon | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | All | 14 | Phase 1 | United States |
| 21 | NCT00831506 (ClinicalTrials.gov) | February 2009 | 27/1/2009 | Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin In Healthy Subjects | Alzheimer Disease;Huntington Disease | Drug: digoxin;Drug: dimebon | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | Both | 12 | Phase 1 | United States |
| 22 | NCT00824590 (ClinicalTrials.gov) | February 2009 | 12/1/2009 | A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function | A Phase 1, Non-Randomized, Open-Label, Single-Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF 01913539] In Subjects With Severely-Impaired And Normal Renal Function | Alzheimer's Disease;Huntington's Disease | Drug: Dimebon | Pfizer | Medivation, Inc. | Completed | 18 Years | 75 Years | Both | 20 | Phase 1 | United States |
| 23 | NCT00788047 (ClinicalTrials.gov) | November 2008 | 7/11/2008 | A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of Dextromethorphan | A Phase 1, Randomized, Open-Label, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon [PF-01913539] On The Single-Dose Pharmacokinetics Of The CYP2D6 Substrate Dextromethorphan In Healthy Subjects | Huntington Disease;Alzheimer Disease | Drug: Dextromethorphan;Drug: Dimebon + Dextromethorphan | Pfizer | Medivation, Inc. | Completed | 18 Years | 55 Years | Both | 14 | Phase 1 | United States |
| 24 | EUCTR2007-003293-25-GB (EUCTR) | 20/11/2007 | 26/07/2007 | A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMOND | A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMOND | Huntington's disease MedDRA version: 9.1;Level: LLT;Classification code 10020469;Term: Huntington's chorea | Product Name: Dimebon Product Code: Dimebon Other descriptive name: Dimebon Dihydrochloride | Medivation, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 25 | NCT00497159 (ClinicalTrials.gov) | July 2007 | 3/7/2007 | A Study of the Novel Drug Dimebon in Patients With Huntington's Disease | A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease | Huntington's Disease | Other: Placebo;Drug: Dimebon | Medivation, Inc. | Huntington Study Group | Completed | 29 Years | N/A | Both | 90 | Phase 2 | United States |
| 26 | NCT00387270 (ClinicalTrials.gov) | October 2006 | 10/10/2006 | Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease | A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease | Huntington's Disease | Drug: Dimebon | Medivation, Inc. | Huntington Study Group | Completed | 18 Years | N/A | Both | 9 | Phase 1/Phase 2 | United States |