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Clinical Trials/NCT00497159
NCT00497159CompletedPhase 2

A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

Medivation, Inc.1 site in 1 country91 target enrollmentStarted: July 2007Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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