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

This study has been completed.
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00387270
First received: October 10, 2006
Last updated: January 3, 2008
Last verified: September 2007

October 10, 2006
January 3, 2008
October 2006
March 2007   (final data collection date for primary outcome measure)
Dose-limiting toxicities [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Dose-limiting toxicities
Complete list of historical versions of study NCT00387270 on ClinicalTrials.gov Archive Site
Unified Huntington's Disease Rating Scale [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Unified Huntington's Disease Rating Scale
Not Provided
Not Provided
 
Safety Study of the Novel Drug Dimebon to Treat Patients With Huntington's Disease
A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Huntington's Disease
Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days
Experimental: A
Dimebon
Intervention: Drug: Dimebon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00387270
DIM03, DIMOND
Not Provided
Karl Kieburtz, MD, Clinical Trial Coordination Center
Medivation, Inc.
Huntington Study Group
Principal Investigator: Karl D Kieburtz, MD University of Rochester Medical School, Huntington Study Group
Medivation, Inc.
September 2007

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