Huntington Disease
Conditions
Keywords
Huntington, Dimebon, HD, Huntingtin
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.
Interventions
DRUGDimebon
20 mg Dimebon orally TID
OTHERPlacebo
Orally TID
Sponsors
Pfizer
Medivation, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Australia, Canada, Denmark, Germany, Sweden, United Kingdom, United States
Outcome results
None listed