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Levetiracetam Treatment of Tardive Dyskinesia

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ClinicalTrials.gov Identifier: NCT00291213
Recruitment Status : Completed
First Posted : February 13, 2006
Last Update Posted : June 6, 2014
Sponsor:
Collaborator:
UCB Pharma
Information provided by (Responsible Party):
Yale University

Brief Summary:
This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: levetiracetam Drug: placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Actual Primary Completion Date : April 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Levetiracetram Administration Drug: levetiracetam
Placebo Comparator: Placebo Drug: placebo



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


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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


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

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 Posted: February 13, 2006    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014

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