Efficacy and Safety of Tetrabenazine in Chorea
Sponsor
Prestwick Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00219804
Collaborator
(none)
Study Details
Study Description
Brief Summary
The primary objective of this study was to establish the absolute reduction of chorea in participants with Huntington's disease(HD) treated with tetrabenazine or placebo
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 0 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prestwick Pharmaceuticals
Investigators
- Principal Investigator: Fred Marshall, M.D., Huntington's Study Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00219804
Other Study ID Numbers:
- 103,004
First Posted:
Sep 22, 2005
Last Update Posted:
Sep 22, 2005
Last Verified:
Sep 1, 2005