Efficacy and Safety of Tetrabenazine in Chorea

Prestwick Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Huntington's Disease

Treatments: Drug: tetrabenazine or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219804

103,004

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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