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Efficacy and Safety of Tetrabenazine in Chorea

This study has been completed.
Information provided by:
Prestwick Pharmaceuticals Identifier:
First received: September 14, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
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
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Tetrabenazine for the Treatment of Huntington's Chorea

Resource links provided by NLM:

Further study details as provided by Prestwick Pharmaceuticals:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00219804

Sponsors and Collaborators
Prestwick Pharmaceuticals
Principal Investigator: Fred Marshall, M.D. Huntington's Study Group
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00219804     History of Changes
Other Study ID Numbers: 103,004
Study First Received: September 14, 2005
Last Updated: September 14, 2005

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on September 21, 2017