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

Official Title: “A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Huntington Disease”

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

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.

Intervention(s) in this Clinical Trial

• Drug: Dimebon
  • 20 mg Dimebon orally TID
• Other: Placebo
  • Orally TID

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
• Experimental: Dimebon

Primary Measures

• A comparison between the mean changes from baseline in the Dimebon 20 mg TID treatment group and the placebo group on the MMSE
  • Time Frame: Week 26
    Safety Issue?: No
• A comparison of the distributions of the CIBIC-plus (ADCS CGIC)in the Dimebon 20 mg TID treatment group and the placebo group
  • Time Frame: Week 26
    Safety Issue?: No

Secondary Measures

• A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the NPI
  • Time Frame: Week 26
    Safety Issue?: No
• A comparison between the mean changes from baseline of the Dimebon 20 mg TID treatment group and the placebo group on the ADCS-ADL
  • Time Frame: Week 26
    Safety Issue?: No
• 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
  • Time Frame: Week 26
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Medivation, Inc. Industry

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00920946

Study ID Number: DIM20

ClinicalTrials.gov Identifier: NCT00920946

Health Authority: United States: Food and Drug Administration

Study website