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CompletedNCT00291213Updated Jun 6, 2014

Levetiracetam Treatment of Tardive Dyskinesia

A Phase 3 interventional study of levetiracetam and placebo in Tardive Dyskinesia, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-06-06.

Sponsored by Yale University · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Tardive Dyskinesia
03

In context

Dyskinesias

270 studies on the registry are indexed under Dyskinesias; 41 are open to participants now.

This study's enrollment of 50 is above the median of 44 across 192 interventional studies indexed under Dyskinesias.

Browse Dyskinesias studies →

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: meet Glazer Morgenstern criteria for TD -

Exclusion Criteria: none

-

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Levetiracetram Administration

    Drug: levetiracetam

  • Placebo comparator
    Placebo

    Drug: placebo

Interventions

  • Druglevetiracetam
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. Abnormal Involuntary Movement Scale (AIMS) Total Score

    Time frame: 12 weeks

07

Study locations

1 site
  • Connecticut Mental Health Center
    New Haven, Connecticut 06519, United States
08

References and documents

Publications

  • Woods SW, Saksa JR, Baker CB, Cohen SJ, Tek C. Effects of levetiracetam on tardive dyskinesia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2008 Apr;69(4):546-54. doi: 10.4088/jcp.v69n0405. PubMed 18312060 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00291213
Lead sponsor
Yale University
Collaborators
UCB Pharma
Responsible party
Sponsor
First posted
Feb 13, 2006
Primary completion
Apr 2006
Last update
Jun 6, 2014

Study contacts

Scott W Woods, MD
principal investigator · Yale School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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