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

Phase 2

Completed

• Conditions: Huntington's Disease
• Interventions: Drug: Dimebon; Other: Placebo

• Registration Number: NCT00497159
• Lead Sponsor: Medivation, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2015-05
• Disposition First Submitted: 2015-05-16
• Disposition First Submitted QC: 2015-05-16
• Last Update Submitted: 2015-05-16
• Disposition First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Dimebon	Dimebon
1	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.	90 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Huntington Study Group; 🇺🇸 Rochester, New York, United States