A Study of the Novel Drug Dimebon in Patients With Huntington's Disease

Medivation, Inc.91 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Huntington's Disease

Interventions

PlaceboOTHER

Placebo TID x 90 days

DimebonDRUG

Dimebon 20 mg TID x 90 days

Eligibility

Sex: ALLMin age: 29 Years

Medical Language ↔ Plain English

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.

Locations (1)

Huntington Study Group

Rochester, New York, United States

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 impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.

Time frame: 90 days

To assess the pharmacokinetics of Dimebon.

Time frame: 90 days

Data from ClinicalTrials.gov

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