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Levetiracetam Treatment of Tardive Dyskinesia

Primary Purpose

Tardive Dyskinesia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

levetiracetam

placebo

About this trial

This is an interventional treatment trial for Tardive Dyskinesia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: meet Glazer Morgenstern criteria for TD - Exclusion Criteria: none -

Sites / Locations

Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Levetiracetram Administration

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Abnormal Involuntary Movement Scale (AIMS) Total Score

Secondary Outcome Measures

Full Information

NCT ID

NCT00291213

First Posted

February 10, 2006

Last Updated

June 5, 2014

Sponsor

Yale University

Collaborators

UCB Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00291213

Brief Title

Levetiracetam Treatment of Tardive Dyskinesia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

April 2006 (Actual)

Study Completion Date

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3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

UCB Pharma

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tardive Dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levetiracetram Administration

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

levetiracetam

Intervention Type

Drug

Intervention Name(s)

placebo

Primary Outcome Measure Information:

Title

Abnormal Involuntary Movement Scale (AIMS) Total Score

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: meet Glazer Morgenstern criteria for TD - Exclusion Criteria: none -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott W Woods, MD

Organizational Affiliation

Yale School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18312060

Citation

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.

Results Reference

derived

Learn more about this trial

Levetiracetam Treatment of Tardive Dyskinesia

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