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NCT00219804 Clinical Trial

Efficacy and Safety of Tetrabenazine in Chorea

Huntington's Disease Clinical Trial

Official title:
A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00219804
Other study ID # 103,004
Secondary ID
Status Completed
Phase Phase 3
First received September 14, 2005
Last updated September 14, 2005

Study information
Verified date September 2005
Source Prestwick Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• tetrabenazine or placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Prestwick Pharmaceuticals
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