Huntington Disease Clinical Trial
— HORIZONOfficial title:
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
NCT number | NCT00920946 |
Other study ID # | DIM20 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | June 12, 2009 |
Last updated | October 11, 2016 |
Start date | July 2009 |
Verified date | October 2016 |
Source | Medivation, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.
Status | Completed |
Enrollment | 403 |
Est. completion date | |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 30 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Medivation, Inc. | Pfizer |
United States, Australia, Canada, Denmark, Germany, Sweden, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Primary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No | |
Secondary | 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 | No |
Status | Clinical Trial | Phase | |
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