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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
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • Dose-limiting toxicities [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Unified Huntington's Disease Rating Scale [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00387270

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

Additional Information:
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  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Karl Kieburtz, MD, Clinical Trial Coordination Center
ClinicalTrials.gov Identifier: NCT00387270     History of Changes
Other Study ID Numbers: DIM03, DIMOND
Study First Received: October 10, 2006
Last Updated: January 3, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Huntington's disease
Dimebon
dose-escalation
Phase 1-2a
 randomized
controlled
double-blind
Unified Huntington's Disease Rating Scale

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Chorea
Dyskinesias
 Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013