NCT00920946

A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 403 (actual)
• Sponsor: Medivation, Inc. · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.

Detailed description

This study is a multicenter Phase 3, randomized, double-blind, placebo-controlled safety and efficacy study of Dimebon treatment in subjects with Huntington disease (HD). The study will evaluate Dimebon 20 mg three times daily (TID) administered orally (PO) for six months (26 weeks) compared with matching placebo TID for the primary safety and efficacy analyses. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, safety laboratory evaluations, and 12-lead electrocardiogram(ECG)assessments.

Conditions

• Huntington Disease

Interventions

Type	Name	Description
DRUG	Dimebon	20 mg Dimebon orally TID
OTHER	Placebo	Orally TID

Timeline

• Start date: 2009-07-01
• Primary completion: 2011-07-01
• First posted: 2009-06-15
• Last updated: 2016-10-12

Locations

37 sites across 7 countries: United States, Australia, Canada, Denmark, Germany, Sweden, United Kingdom