Huntington's Disease
Conditions
Keywords
Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.
Brief summary
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
Interventions
OTHERPlacebo
Placebo TID x 90 days
DRUGDimebon
Dimebon 20 mg TID x 90 days
Sponsors
Huntington Study Group
Medivation, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
29 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD; * Able to take medication (capsules) by mouth.
Exclusion criteria
* Clinical evidence of unstable medical illness; * Females who are pregnant or lactating or who intend to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease. | 90 days |
| To assess the pharmacokinetics of Dimebon. | 90 days |
Countries
United States
Outcome results
None listed