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

Phase 3

Completed

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

• Registration Number: NCT00920946
• Lead Sponsor: Medivation, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-12
• Study First Posted: 2009-06-15
• Study Start: 2009-07
• Primary Completion: 2011-07
• Status Verified: 2016-10
• Disposition First Submitted: 2016-10-11
• Disposition First Submitted QC: 2016-10-11
• Last Update Submitted: 2016-10-11
• Disposition First Posted: 2016-10-12
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

Inclusion Criteria

• Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36

• Have cognitive impairment as noted by the following:

  1. A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
  2. A subjective assessment of cognitive impairment with decline from pre-HD levels by the Investigator after interviewing the subject and caregiver;

• Are willing and able to give informed consent

• Aged 30 years or older

• Have a caregiver who assists/spends time with the subject at least five days per week for at least three hours per day and has intimate knowledge of the subject's cognitive, functional, and emotional states, and of the subject's personal care.

Exclusion Criteria

• Had onset of symptoms prior to age 18
• Have any major medical illness or unstable medical condition within 180 days of screening that may interfere with the subject's ability to comply with study procedures and abide by study restrictions, or with the ability to interpret safety data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dimebon	Dimebon	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE	Week 26
A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group	Week 26

Secondary Outcome Measures

Name	Time	Method
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI	Week 26
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL	Week 26
A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the UHDRS'99 Total Motor Score	Week 26