Efficacy and Safety of Tetrabenazine in Chorea

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prestwick Pharmaceuticals
• Treatments: Tetrabenazine

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