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Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease

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. Identifier: NCT00387270
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : January 4, 2008
Huntington Study Group
Information provided by:
Medivation, Inc.

Brief Summary:
This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning.

Condition or disease Intervention/treatment Phase
Huntington's Disease Drug: Dimebon Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
Study Start Date : October 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days

Primary Outcome Measures :
  1. Dose-limiting toxicities [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Unified Huntington's Disease Rating Scale [ Time Frame: 7 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical features of Huntington's disease and a confirmatory family history of HD, or a CAG repeat expansion greater than or equal to 36
  • Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the Unified Huntington's Disease Rating Scale

Exclusion Criteria:

  • Clinical evidence of unstable medical illness

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 identifier (NCT number): NCT00387270

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United States, New York
Huntington Study Group
Rochester, New York, United States, 14620
Sponsors and Collaborators
Medivation, Inc.
Huntington Study Group
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Principal Investigator: Karl D Kieburtz, MD University of Rochester Medical School, Huntington Study Group
Additional Information:
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Responsible Party: Karl Kieburtz, MD, Clinical Trial Coordination Center Identifier: NCT00387270    
Other Study ID Numbers: DIM03
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: September 2007
Keywords provided by Medivation, Inc.:
Huntington's disease
Phase 1-2a
Unified Huntington's Disease Rating Scale
Additional relevant MeSH terms:
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Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders