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A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease (HORIZON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00920946
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : October 12, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Medivation, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Huntington Disease Drug: Dimebon Other: Placebo Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Mile-to-Moderate Huntington Disease
Study Start Date : July 2009
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Other: Placebo
Orally TID
Experimental: Dimebon Drug: Dimebon
20 mg Dimebon orally TID


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920946


Locations
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United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Davis, California, United States, 95616
Irvine, California, United States, 92697
La Jolla, California, United States, 92161
San Francisco, California, United States, 94143
United States, Florida
Gainsville, Florida, United States, 32610
Miami, Florida, United States, 33136
United States, Idaho
Boise, Idaho, United States, 83702
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Kansas
Kansas City, Kansas, United States, 66160
Wichita, Kansas, United States, 67206
United States, Massachusetts
Charlestown, Massachusetts, United States, 02129
United States, Minnesota
Golden Valley, Minnesota, United States, 55427
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, New York
New York, New York, United States, 10032
Rochester, New York, United States, 14620
United States, North Carolina
Durham, North Carolina, United States, 27705
Winstom-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43210
United States, Oregon
Portland, Oregon, United States, 97201
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19107
Pittsburgh, Pennsylvania, United States, 15213
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Wentworthville, New South Wales, Australia
Australia, Victoria
Melbourne, Victoria, Australia
Australia
Perth, Australia
Canada, British Columbia
Vancouver, British Columbia, Canada
Canada, Ontario
London, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Denmark
Copenhagen, Denmark
Germany
Oberer Eslebberg, Ulm, Germany
Aachen, Germany
Bochum, Germany
Hamburg, Germany
Sweden
Stockholm, Sweden
United Kingdom
Birmingham, United Kingdom
Sponsors and Collaborators
Medivation, Inc.
Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00920946    
Other Study ID Numbers: DIM20
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Keywords provided by Medivation, Inc.:
Huntington
Dimebon
HD
Huntingtin
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders