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

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.
ClinicalTrials.gov Identifier: NCT00497159
Recruitment Status : Completed
First Posted : July 6, 2007
Last Update Posted : June 8, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Huntington's Disease Other: Placebo Drug: Dimebon Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2007
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Placebo
Other: Placebo
Placebo TID x 90 days
Experimental: 2
Dimebon
Drug: Dimebon
Dimebon 20 mg TID x 90 days


Outcome Measures

Primary Outcome Measures :
  1. To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. To assess the pharmacokinetics of Dimebon. [ Time Frame: 90 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   29 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT00497159     History of Changes
Other Study ID Numbers: DIM05
First Posted: July 6, 2007    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: May 2015

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
Neurocognitive Disorders
Mental Disorders