Dimebon ( DrugBank: Dimebon )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
8ハンチントン病26

8. ハンチントン病


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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-018123-32-SE
(EUCTR)
30/09/201010/06/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-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, IncNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
2EUCTR2009-018123-32-NL
(EUCTR)
23/08/201014/04/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-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, IncNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
3EUCTR2009-018123-32-IT
(EUCTR)
28/07/201015/07/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease(Protocol DIM20EXT) - Horizon-PlusHORIZON-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.NULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
4EUCTR2009-018123-32-DE
(EUCTR)
07/06/201002/03/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-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, IncNULLNot RecruitingFemale: yes
Male: yes
350Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
5EUCTR2009-018123-32-GB
(EUCTR)
14/05/201018/03/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-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, IncNULLNot RecruitingFemale: yes
Male: yes
350Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
6EUCTR2009-018123-32-DK
(EUCTR)
23/04/201016/03/2010HORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects with Huntington Disease - HORIZON-PlusHORIZON-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, IncNULLNot RecruitingFemale: yes
Male: yes
350United Kingdom;Germany;Netherlands;Denmark;Italy;Sweden
7NCT01085266
(ClinicalTrials.gov)
February 201010/3/2010An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington DiseaseHORIZON-Plus: An Open-Label Extension of the HORIZON Protocol (DIM20) Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington DiseaseHuntington DiseaseDrug: Dimebon (latrepirdine)Medivation, Inc.Pfizer;PfizerTerminated30 YearsN/ABoth362Phase 3NULL
8EUCTR2009-011800-44-NL
(EUCTR)
20/01/201028/09/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA 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, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
9EUCTR2009-011800-44-IT
(EUCTR)
22/12/200904/11/2009A 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 - DIM20A 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.NULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
10EUCTR2009-011800-44-SE
(EUCTR)
14/12/200923/09/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA 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, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
11EUCTR2009-011800-44-GB
(EUCTR)
07/10/200905/06/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA 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, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
12EUCTR2009-011800-44-DE
(EUCTR)
07/10/200906/07/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA 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, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
13NCT00975481
(ClinicalTrials.gov)
October 200910/9/2009A Study To Evaluate The Abuse Potential Of Single Oral Doses Of Dimebon (Latrepirdine) In Healthy Recreational Polydrug UsersA 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 UsersAlzheimer's Disease;Huntington's DiseaseDrug: dimebon;Drug: placebo;Drug: alprazolamPfizerMedivation, Inc.Completed18 Years55 YearsAll36Phase 1Canada
14NCT00990613
(ClinicalTrials.gov)
October 20096/10/2009A Study Evaluating The Absorption Of Dimebon Into The Body From A Dimebon Solution Applied To The SkinA 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 AdultsAlzheimer's Disease;Huntington's DiseaseDrug: Dimebon IR;Drug: Dimebon TransdermalPfizerMedivation, Inc.Completed50 Years85 YearsBoth19Phase 1United States
15NCT00988624
(ClinicalTrials.gov)
October 20091/10/2009A 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 DiseaseDrug: Dimebon IR Tablet;Drug: Dimebon MR1;Drug: Dimebon MR2;Drug: Dimebon MR3;Drug: Dimebon MR4PfizerMedivation, Inc.Completed18 Years55 YearsBoth20Phase 1United States
16EUCTR2009-011800-44-DK
(EUCTR)
11/09/200904/08/2009A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients with Mild-to-Moderate Huntington Disease - HORIZONA 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, IncNULLNot RecruitingFemale: yes
Male: yes
350Phase 3Germany;United Kingdom;Netherlands;Denmark;Italy;Sweden
17NCT00920946
(ClinicalTrials.gov)
July 200912/6/2009A Safety and Efficacy Study of Dimebon in Patients With Huntington DiseaseA Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington DiseaseHuntington DiseaseDrug: Dimebon;Other: PlaceboMedivation, Inc.Pfizer;PfizerCompleted30 YearsN/ABoth403Phase 3United States;Australia;Canada;Denmark;Germany;Sweden;United Kingdom
18NCT00931073
(ClinicalTrials.gov)
July 20091/7/2009A 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 MetabolizersA 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 SubjectsAlzheimer's Disease;Huntington's DiseaseDrug: Dimebon alone;Drug: Dimebon + Ketoconazole;Drug: Dimebon + OmeprazolePfizerMedivation, Inc.Completed18 Years55 YearsBoth24Phase 1United States
19NCT00825084
(ClinicalTrials.gov)
February 200912/1/2009A Phase 1 Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Dimebon [PF-01913539] In Japanese And Western Healthy SubjectsA 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 SubjectsAlzheimer's Disease;Huntington's DiseaseDrug: DimebonPfizerMedivation, Inc.Completed18 Years55 YearsBoth45Phase 1United States
20NCT00824590
(ClinicalTrials.gov)
February 200912/1/2009A 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 FunctionA 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 FunctionAlzheimer's Disease;Huntington's DiseaseDrug: DimebonPfizerMedivation, Inc.Completed18 Years75 YearsBoth20Phase 1United States
21NCT00827034
(ClinicalTrials.gov)
February 200920/1/2009A 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 SubjectsA 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 SubjectsAlzheimer's Disease;Huntington's DiseaseDrug: Warfarin;Drug: DimebonPfizerMedivation, Inc.Completed18 Years55 YearsAll14Phase 1United States
22NCT00831506
(ClinicalTrials.gov)
February 200927/1/2009Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy SubjectsA 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 SubjectsAlzheimer Disease;Huntington DiseaseDrug: digoxin;Drug: dimebonPfizerMedivation, Inc.Completed18 Years55 YearsBoth12Phase 1United States
23NCT00788047
(ClinicalTrials.gov)
November 20087/11/2008A Phase 1 Study To Evaluate The Effect Of Dimebon On The Pharmacokinetics Of DextromethorphanA 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 SubjectsHuntington Disease;Alzheimer DiseaseDrug: Dextromethorphan;Drug: Dimebon + DextromethorphanPfizerMedivation, Inc.Completed18 Years55 YearsBoth14Phase 1United States
24EUCTR2007-003293-25-GB
(EUCTR)
20/11/200726/07/2007A MULTI-CENTER, PHASE 2 RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED STUDY OF DIMEBON IN SUBJECTS WITH HUNTINGTON’S DISEASE - DIMONDA 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.NULLNot 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): noUnited Kingdom
25NCT00497159
(ClinicalTrials.gov)
July 20073/7/2007A Study of the Novel Drug Dimebon in Patients With Huntington's DiseaseA Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's DiseaseHuntington's DiseaseOther: Placebo;Drug: DimebonMedivation, Inc.Huntington Study GroupCompleted29 YearsN/ABoth90Phase 2United States
26NCT00387270
(ClinicalTrials.gov)
October 200610/10/2006Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's DiseaseA Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's DiseaseHuntington's DiseaseDrug: DimebonMedivation, Inc.Huntington Study GroupCompleted18 YearsN/ABoth9Phase 1/Phase 2United States