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

This study has been completed.
Huntington Study Group
Information provided by:
Medivation, Inc. Identifier:
First received: October 10, 2006
Last updated: January 3, 2008
Last verified: September 2007
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 Intervention Phase
Huntington's Disease Drug: Dimebon Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Medivation, Inc.:

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

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

Enrollment: 9
Study Start Date: October 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00387270

United States, New York
Huntington Study Group
Rochester, New York, United States, 14620
Sponsors and Collaborators
Medivation, Inc.
Huntington Study Group
Principal Investigator: Karl D Kieburtz, MD University of Rochester Medical School, Huntington Study Group
  More Information

Additional Information:
Responsible Party: Karl Kieburtz, MD, Clinical Trial Coordination Center Identifier: NCT00387270     History of Changes
Other Study ID Numbers: DIM03
Study First Received: October 10, 2006
Last Updated: January 3, 2008

Keywords provided by Medivation, Inc.:
Huntington's disease
Phase 1-2a
Unified Huntington's Disease Rating Scale

Additional relevant MeSH terms:
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
Dyskinesias processed this record on August 18, 2017