A Study of the Novel Drug Dimebon in Patients With Huntington's Disease

Verified by: Medivation, Inc., July 2008
First Received: July 3, 2007 | Last Updated: July 24, 2008 | Phase: Phase 2 | Start Date: July 2007
Overall Status: Completed | Estimated Enrollment: 90
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This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease...

Brief Summary

Official Title: “A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease”

This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

  • Other: Placebo
    • Placebo TID x 90 days
  • Drug: Dimebon
    • Dimebon 20 mg TID x 90 days

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: 1
    • Placebo
  • Experimental: 2
    • Dimebon

Outcome Measures for this Clinical Trial

Primary Measures

  • To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
    • Time Frame: 90 days
      Safety Issue?: Yes

Secondary Measures

  • To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
    • Time Frame: 90 days
      Safety Issue?: No
  • To assess the pharmacokinetics of Dimebon.
    • Time Frame: 90 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
  • Able to take medication (capsules) by mouth.

Exclusion Criteria:

  • Clinical evidence of unstable medical illness;
  • Females who are pregnant or lactating or who intend to become pregnant during the study period.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 29 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Medivation, Inc. Industry

Overall Clinical Trial Officials and Contacts

Karl Kieburtz, MD, MPH Principal Investigator Huntington Study Group, University of Rochester  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00497159

Study ID Number: DIM05

ClinicalTrials.gov Identifier: NCT00497159

Health Authority: United States: Food and Drug Administration

The Huntington Study Group is a non-profit group of physicians and health care providers from medical centers in the US, Canada, Europe, and Australia, experienced in the care of HD patients and dedicated to clinical research of HD. Click for more info.

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00497159