A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
NCT ID: NCT00920946
Last Updated: 2016-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
403 participants
INTERVENTIONAL
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo
Orally TID
Dimebon
Dimebon
20 mg Dimebon orally TID
Interventions
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Dimebon
20 mg Dimebon orally TID
Placebo
Orally TID
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Medivation, Inc.
INDUSTRY
Responsible Party
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Locations
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Scottsdale, Arizona, United States
Davis, California, United States
Irvine, California, United States
La Jolla, California, United States
San Francisco, California, United States
Gainsville, Florida, United States
Miami, Florida, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Charlestown, Massachusetts, United States
Golden Valley, Minnesota, United States
St Louis, Missouri, United States
New York, New York, United States
Rochester, New York, United States
Durham, North Carolina, United States
Winstom-Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Milwaukee, Wisconsin, United States
Wentworthville, New South Wales, Australia
Melbourne, Victoria, Australia
Perth, , Australia
Vancouver, British Columbia, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Copenhagen, , Denmark
Oberer Eslebberg, Ulm, Germany
Aachen, , Germany
Bochum, , Germany
Hamburg, , Germany
Stockholm, , Sweden
Birmingham, , United Kingdom
Countries
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References
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HORIZON Investigators of the Huntington Study Group and European Huntington's Disease Network. A randomized, double-blind, placebo-controlled study of latrepirdine in patients with mild to moderate Huntington disease. JAMA Neurol. 2013 Jan;70(1):25-33. doi: 10.1001/2013.jamaneurol.382.
Related Links
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Study website
Other Identifiers
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DIM20
Identifier Type: -
Identifier Source: org_study_id
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