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

• ClinicalTrials.gov Identifier: NCT00920946
• Recruitment Status: Completed
• First Posted: June 15, 2009
• Last Update Posted: October 12, 2016
• Sponsor: Medivation, Inc.
• Collaborator: Pfizer
• Information provided by (Responsible Party): Medivation, Inc.

Study Description

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

• 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

Arms and Interventions

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

Outcome Measures

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

• 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

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:

Study website 

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

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.

• Responsible Party: Medivation, Inc.
• ClinicalTrials.gov Identifier: NCT00920946
• Other Study ID Numbers: DIM20
• First Posted: June 15, 2009
• Last Update Posted: October 12, 2016
• Last Verified: October 2016

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; Neurocognitive Disorders; Mental Disorders