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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 October 2016
• Main ID: NCT00920946
• Date of registration: 12/06/2009
• Prospective Registration: Yes
• Primary sponsor: Medivation, Inc.
• Public title: A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease HORIZON
• Scientific title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
• Date of first enrolment: July 2009
• Target sample size: 403
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00920946
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Denmark, Germany, Sweden, United Kingdom, United States

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Huntington Disease

Intervention(s)

Drug: Dimebon

Other: Placebo

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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]

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]

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]

Secondary ID(s)

DIM20

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer