Efficacy and Safety of Tetrabenazine in Chorea

This study has been completed.

Sponsored by:	Prestwick Pharmaceuticals
Information provided by:	Prestwick Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00219804

Purpose

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

Condition	Intervention	Phase
Huntington's Disease	Drug: tetrabenazine or placebo	Phase III

Genetics Home Reference related topics: chorea-acanthocytosis familial encephalopathy with neuroserpin inclusion bodies familial paroxysmal nonkinesigenic dyskinesia Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease Hurricanes

Drug Information available for: Tetrabenazine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219804

Sponsors and Collaborators

Prestwick Pharmaceuticals

Investigators

Principal Investigator:

Fred Marshall, M.D.

Huntington's Study Group

More Information

Study ID Numbers:	103,004
Study First Received:	September 14, 2005
Last Updated:	September 14, 2005
ClinicalTrials.gov Identifier:	NCT00219804
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Ganglion Cysts
Huntington disease
Basal Ganglia Diseases
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Dyskinesias
Cognition Disorders
Chorea

Delirium, Dementia, Amnestic, Cognitive Disorders
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Mental Disorders
Movement Disorders
Dementia
Huntington Disease
Tetrabenazine
Delirium

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009