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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00920946
First received: June 12, 2009
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

The purpose of this study is to determine if Dimebon is safe and effective for the treatment of cognitive impairment in Huntington disease.


Condition Intervention Phase
Huntington Disease
Drug: Dimebon
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Orally TID
Experimental: Dimebon Drug: Dimebon
20 mg Dimebon orally TID

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00920946

  Hide Study Locations
Locations
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

Additional Information:
No publications provided by Medivation, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lynn Seely, MD / Chief Medical Officer, Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00920946     History of Changes
Other Study ID Numbers: DIM20
Study First Received: June 12, 2009
Last Updated: April 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Huntington
Dimebon
HD
Huntingtin

Additional relevant MeSH terms:
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014