Trial record 6 of 138 for:    Chorea

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-Blind
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
Genders Eligible for Study:   Both
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
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 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurocognitive Disorders
Neurodegenerative Diseases
Adrenergic Agents
Adrenergic Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs processed this record on May 23, 2016