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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00219804 |
Date of registration:
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14/09/2005 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Efficacy and Safety of Tetrabenazine in Chorea
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Scientific title:
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A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea |
Date of first enrolment:
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January 2000 |
Target sample size:
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Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT00219804 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
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Phase:
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Phase 3
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Contacts
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Name:
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Fred Marshall, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Huntington's Study Group |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 18 years of age or older
- suffer from manifest HD as confirmed by genetic testing
- Meet chorea and total functional capacity scores on Unified Huntington's Disease
Rating Scale
- Meet criteria on Hamilton Depression Rating Scale, Unified Parkinson's Disease Rating
Scale dysphagia and dysarthria scale
- Independently ambulatory
Exclusion Criteria
- previous treatment with tetrabenazine
- unstable or serious medical or psychiatric illness
- concomitant use identified drugs
- untreated depression
- lack of caregiver
Age minimum:
18 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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Drug: tetrabenazine or placebo
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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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