- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00291213
Levetiracetam Treatment of Tardive Dyskinesia
June 5, 2014 updated by: Yale University
This is a placebo-controlled study designed to learn if levetiracetam is effective for tardive dyskinesia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- Connecticut Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: meet Glazer Morgenstern criteria for TD -
Exclusion Criteria: none
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
|
Experimental: Levetiracetram Administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Abnormal Involuntary Movement Scale (AIMS) Total Score
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott W Woods, MD, Yale School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Actual)
April 1, 2006
Study Registration Dates
First Submitted
February 10, 2006
First Submitted That Met QC Criteria
February 10, 2006
First Posted (Estimate)
February 13, 2006
Study Record Updates
Last Update Posted (Estimate)
June 6, 2014
Last Update Submitted That Met QC Criteria
June 5, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YaleHIC26585
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tardive Dyskinesia
-
Neurocrine BiosciencesCompletedTardive Dyskinesia (TD)United States, Puerto Rico
-
GGZ CentraalUniversity Medical Center Groningen; Maastricht UniversityTerminatedTardive Dyskinesia | Tardive DystoniaNetherlands
-
Synchroneuron Inc.WithdrawnDrug-induced Tardive DyskinesiaUnited States
-
Centre for Addiction and Mental HealthMerck KGaA, Darmstadt, GermanyTerminatedNeuroleptic-induced Tardive DyskinesiaCanada, India
-
Taoyuan Psychiatric Center, Ministry of Health...Department of HealthCompletedNeuroleptic-Induced Tardive DyskinesiaTaiwan
-
Mitsubishi Tanabe Pharma CorporationCompleted
-
Neurocrine BiosciencesCompletedTardive DyskinesiaUnited States
-
Shanghai Mental Health CenterUnknownTardive DyskinesiaChina
-
Neurocrine BiosciencesEvideraUnknownTardive DyskinesiaUnited States
-
Neurocrine BiosciencesCompletedTardive DyskinesiaUnited States, Puerto Rico
Clinical Trials on placebo
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SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
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National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
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AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States