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Levetiracetam Treatment of Tardive Dyskinesia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00291213
First Posted: February 13, 2006
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Yale University
  Purpose
This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.

Condition Intervention Phase
Tardive Dyskinesia Drug: levetiracetam Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Abnormal Involuntary Movement Scale (AIMS) Total Score [ Time Frame: 12 weeks ]

Enrollment: 50
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetram Administration Drug: levetiracetam
Placebo Comparator: Placebo Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: meet Glazer Morgenstern criteria for TD -

Exclusion Criteria: none

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291213


Locations
United States, Connecticut
Connecticut Mental Health Center
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
UCB Pharma
Investigators
Principal Investigator: Scott W Woods, MD Yale School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00291213     History of Changes
Other Study ID Numbers: YaleHIC26585
First Submitted: February 10, 2006
First Posted: February 13, 2006
Last Update Posted: June 6, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Dyskinesias
Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Dyskinesia, Drug-Induced
Etiracetam
Piracetam
Anticonvulsants
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs