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

Verified by: Medivation, Inc., September 2007
First Received: October 10, 2006 | Last Updated: January 3, 2008 | Phase: Phase 1/Phase 2 | Start Date: October 2006
Overall Status: Completed | Estimated Enrollment: 9
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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...

Brief Summary

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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

  • Drug: Dimebon
    • Dimebon 10 or 20 mg TID x 7 days

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: A
    • Dimebon

Outcome Measures for this Clinical Trial

Primary Measures

  • Dose-limiting toxicities
    • Time Frame: 7 days
      Safety Issue?: Yes

Secondary Measures

  • Unified Huntington's Disease Rating Scale
    • Time Frame: 7 days
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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 D Kieburtz, MD Principal Investigator University of Rochester Medical School, Huntington Study Group  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00387270

Study ID Number: DIM03

ClinicalTrials.gov Identifier: NCT00387270

Health Authority: United States: Food and Drug Administration

The Huntington Study Group (HSG) is a non-profit group of physicians and other health care providers from medical centers in the U.S., Canada, Europe, and Australia, experienced in the care of Huntington patients and dedicated to clinical research of HD

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00387270