Efficacy and Safety of Tetrabenazine in Chorea

This study has been completed.

Sponsor:

Information provided by:

Prestwick Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00219804

First received: September 14, 2005

Last updated: NA

Last verified: September 2005

History: No changes posted

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 3


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

Resource links provided by NLM:

Genetics Home Reference related topics: chorea-acanthocytosis Huntington disease McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Huntington's Disease

Drug Information available for: Tetrabenazine

Genetic and Rare Diseases Information Center resources: Huntington Disease

U.S. FDA Resources

Further study details as provided by Prestwick Pharmaceuticals:

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Prestwick Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Frank S. Tetrabenazine as anti-chorea therapy in Huntington disease: an open-label continuation study. Huntington Study Group/TETRA-HD Investigators. BMC Neurol. 2009 Dec 18;9:62. doi: 10.1186/1471-2377-9-62. Erratum in: BMC Neurol. 2011;11:18.


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

Additional relevant MeSH terms:


Huntington Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chorea Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Dementia Dyskinesias Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders	Movement Disorders Nervous System Diseases Neurodegenerative Diseases Tetrabenazine Adrenergic Agents Adrenergic Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs

ClinicalTrials.gov processed this record on March 03, 2015

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