FindTrial
Sign In

Efficacy and Safety of Tetrabenazine in Chorea

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00219804
Enrollment
Unknown
Registered
2005-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2005-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Huntington's Disease

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

Interventions

DRUGtetrabenazine or placebo

Sponsors

Prestwick Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026