NCT00497159CompletedPhase 2
A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Medivation, Inc.
- Enrollment
- 91
- Locations
- 1
- Primary Endpoint
- To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Study Overview
Brief Summary
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 29 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
- •Able to take medication (capsules) by mouth.
Exclusion Criteria
- •Clinical evidence of unstable medical illness;
- •Females who are pregnant or lactating or who intend to become pregnant during the study period.
Arms & Interventions
1
Placebo Comparator
Placebo
Intervention: Placebo (Other)
2
Experimental
Dimebon
Intervention: Dimebon (Drug)
Outcomes
Primary Outcomes
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Time Frame: 90 days
Secondary Outcomes
- To assess the pharmacokinetics of Dimebon.(90 days)
- To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.(90 days)
Investigators
Study Sites (1)
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