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Trial record 12 of 97 for:    Medivation

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

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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.

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 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
Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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

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


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Sponsors and Collaborators
Medivation, Inc.
Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00920946     History of Changes
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:
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