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A Study of the Novel Drug Dimebon in Patients With Huntington's Disease (DIMOND)

This study has been completed.
Sponsor:
Collaborator:
Huntington Study Group
Information provided by:
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT00497159
First received: July 3, 2007
Last updated: July 24, 2008
Last verified: July 2008
History of Changes
  Purpose

This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.


Condition Intervention Phase
Huntington's Disease
 Other: Placebo
Drug: Dimebon
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Phase 2 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:
  • To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics of Dimebon. [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: July 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo
 Other: Placebo
Placebo TID x 90 days
Other Name: Placebo
Experimental: 2
Dimebon
 Drug: Dimebon
Dimebon 20 mg TID x 90 days
Other Name: Dimebon

  Eligibility

Ages Eligible for Study:   29 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
  • Able to take medication (capsules) by mouth.

Exclusion Criteria:

  • Clinical evidence of unstable medical illness;
  • Females who are pregnant or lactating or who intend to become pregnant during the study period.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497159

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 Kieburtz, MD, MPH Huntington Study Group, University of Rochester
  More Information

Additional Information:
The Huntington Study Group is a non-profit group of physicians and health care providers from medical centers in the US, Canada, Europe, and Australia, experienced in the care of HD patients and dedicated to clinical research of HD. Click for more info.  This link exits the ClinicalTrials.gov site

No publications provided by Medivation, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Karl Kieburtz, MD, Clinical Trial Coordination Center, University of Rochester
ClinicalTrials.gov Identifier: NCT00497159     History of Changes
Other Study ID Numbers: DIM05
Study First Received: July 3, 2007
Last Updated: July 24, 2008
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Medivation, Inc.:
Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.

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 16, 2013