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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
403
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
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 ADCS-ADL
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
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Scottsdale, Arizona, United States
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Davis, California, United States
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Irvine, California, United States
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La Jolla, California, United States
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San Francisco, California, United States
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Gainsville, Florida, United States
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Miami, Florida, United States
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Boise, Idaho, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
...and 27 more locations