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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

June 12, 2009
April 13, 2011
Not Provided
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT00920946 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Safety and Efficacy Study of Dimebon in Patients With Huntington Disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Dimebon in Patients With Huntington Disease

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

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.

Interventional
Phase 3
Primary Purpose: Treatment
Huntington Disease
  • Drug: Dimebon
    20 mg Dimebon orally TID
  • Other: Placebo
    Orally TID
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
  • Experimental: Dimebon
    Intervention: Drug: Dimebon
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.
 
Completed
Not Provided
Not Provided
Not Provided

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
Both
30 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Denmark,   Germany,   Sweden,   United Kingdom
 
NCT00920946
DIM20
Yes
Lynn Seely, MD / Chief Medical Officer, Medivation, Inc.
Medivation, Inc.
Pfizer
Not Provided
Medivation, Inc.
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP