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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00497159 |
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Date of registration:
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03/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
DIMOND |
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Scientific title:
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A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease |
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Date of first enrolment:
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July 2007 |
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Target sample size:
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90 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00497159 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Karl Kieburtz, MD, MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Huntington Study Group, University of Rochester |
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Key inclusion & exclusion criteria
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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.
Age minimum:
29 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Huntington's Disease
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Intervention(s)
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Other: Placebo
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Drug: Dimebon
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Primary Outcome(s)
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To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
[Time Frame: 90 days]
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Secondary Outcome(s)
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To assess the pharmacokinetics of Dimebon.
[Time Frame: 90 days]
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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]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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