Text Size

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:

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
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):

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

ClinicalTrials.gov processed this record on May 16, 2013