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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00387270
First Posted: October 12, 2006
Last Update Posted: January 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.
  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
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
Dimebon
Drug: Dimebon
Dimebon 10 or 20 mg TID x 7 days

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: October 10, 2006
First Posted: October 12, 2006
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