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

Huntington Disease Clinical Trial

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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Huntington Disease

• NCT number: NCT00920946
• Study type: Interventional
• Source: Medivation, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: July 2009