A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
HORIZON
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
1 other identifier
interventional
403
7 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2009
CompletedFirst Posted
Study publicly available on registry
June 15, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedOctober 12, 2016
October 1, 2016
2 years
June 12, 2009
October 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
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
Study Arms (2)
Placebo
PLACEBO COMPARATORDimebon
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Have clinical features of HD and a CAG polyglutamate repeat expansion ≥ 36
- Have cognitive impairment as noted by the following:
- A Screening MMSE AND a baseline (pre-dose) MMSE score between 10 and 26 (inclusive); and
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivation, Inc.lead
- Pfizercollaborator
Study Sites (37)
Unknown Facility
Scottsdale, Arizona, 85259, United States
Unknown Facility
Davis, California, 95616, United States
Unknown Facility
Irvine, California, 92697, United States
Unknown Facility
La Jolla, California, 92161, United States
Unknown Facility
San Francisco, California, 94143, United States
Unknown Facility
Gainsville, Florida, 32610, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Boise, Idaho, 83702, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Wichita, Kansas, 67206, United States
Unknown Facility
Charlestown, Massachusetts, 02129, United States
Unknown Facility
Golden Valley, Minnesota, 55427, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Rochester, New York, 14620, United States
Unknown Facility
Durham, North Carolina, 27705, United States
Unknown Facility
Winstom-Salem, North Carolina, 27157, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Columbus, Ohio, 43210, United States
Unknown Facility
Portland, Oregon, 97201, United States
Unknown Facility
Philadelphia, Pennsylvania, 19107, United States
Unknown Facility
Pittsburgh, Pennsylvania, 15213, United States
Unknown Facility
Milwaukee, Wisconsin, 53226, United States
Unknown Facility
Wentworthville, New South Wales, Australia
Unknown Facility
Melbourne, Victoria, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Vancouver, British Columbia, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
Unknown Facility
Copenhagen, Denmark
Unknown Facility
Oberer Eslebberg, Ulm, Germany
Unknown Facility
Aachen, Germany
Unknown Facility
Bochum, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Stockholm, Sweden
Unknown Facility
Birmingham, United Kingdom
Related Publications (1)
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.
PMID: 23108692DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2009
First Posted
June 15, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2011
Last Updated
October 12, 2016
Record last verified: 2016-10