Efficacy and Safety of Tetrabenazine in Chorea

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

Completed

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Key information

Conditions

Huntington's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Huntington Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tetrabenazine or placebo

Drug

Sponsors and collaborators

Lead sponsor

Prestwick Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

First posted: Sep 22, 2005
Registry last updated: Sep 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed