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Trial record 1 of 1 for:    NCT00387270
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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.
 
ClinicalTrials.gov Identifier: NCT00387270
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : January 4, 2008
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.

Tracking Information
First Submitted Date  ICMJE October 10, 2006
First Posted Date  ICMJE October 12, 2006
Last Update Posted Date January 4, 2008
Study Start Date  ICMJE October 2006
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Dose-limiting toxicities [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
Dose-limiting toxicities
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2008)
Unified Huntington's Disease Rating Scale [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2006)
Unified Huntington's Disease Rating Scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
Official Title  ICMJE A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days
Study Arms  ICMJE Experimental: A
Dimebon
Intervention: Drug: Dimebon
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 3, 2008)
9
Original Enrollment  ICMJE
 (submitted: October 10, 2006)
75
Actual Study Completion Date  ICMJE March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00387270
Other Study ID Numbers  ICMJE DIM03
DIMOND
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karl Kieburtz, MD, Clinical Trial Coordination Center
Study Sponsor  ICMJE Medivation, Inc.
Collaborators  ICMJE Huntington Study Group
Investigators  ICMJE
Principal Investigator: Karl D Kieburtz, MD University of Rochester Medical School, Huntington Study Group
PRS Account Medivation, Inc.
Verification Date September 2007

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