Levetiracetam Treatment of Tardive Dyskinesia

This study has been completed.
Sponsor:
Collaborator:
UCB, Inc.
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00291213
First received: February 10, 2006
Last updated: June 5, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: meet Glazer Morgenstern criteria for TD -

Exclusion Criteria: none

-

  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 ClinicalTrials.gov identifier: NCT00291213

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

No publications provided by Yale University

Additional 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
Study First Received: February 10, 2006
Last Updated: June 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dyskinesias
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014