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

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ClinicalTrials.gov Identifier: NCT00387270
Recruitment Status : Completed
First Posted : October 12, 2006
Last Update Posted : January 4, 2008
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Huntington's Disease Drug: Dimebon Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
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
Study Start Date : October 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Dimebon
Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Karl Kieburtz, MD, Clinical Trial Coordination Center
ClinicalTrials.gov Identifier: NCT00387270     History of Changes
Other Study ID Numbers: DIM03
DIMOND
First Posted: October 12, 2006    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: September 2007

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
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Dementia
Chorea
Dyskinesias