A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease (HORIZON)
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ClinicalTrials.gov Identifier: NCT00920946 |
Recruitment Status
:
Completed
First Posted
: June 15, 2009
Last Update Posted
: October 12, 2016
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Sponsor:
Medivation, Inc.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.
Tracking Information | |||
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First Submitted Date ICMJE | June 12, 2009 | ||
First Posted Date ICMJE | June 15, 2009 | ||
Last Update Posted Date | October 12, 2016 | ||
Study Start Date ICMJE | July 2009 | ||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT00920946 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease | ||
Official Title ICMJE | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease | ||
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. | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Huntington Disease | ||
Intervention ICMJE |
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Study Arms |
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Publications * | 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. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
403 | ||
Original Enrollment ICMJE | Not Provided | ||
Study Completion Date | Not Provided | ||
Actual Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 30 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Australia, Canada, Denmark, Germany, Sweden, United Kingdom, United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00920946 | ||
Other Study ID Numbers ICMJE | DIM20 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Medivation, Inc. | ||
Study Sponsor ICMJE | Medivation, Inc. | ||
Collaborators ICMJE | Pfizer | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Medivation, Inc. | ||
Verification Date | October 2016 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |