NCT00291213

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Last Updated

June 6, 2014

Status Verified

June 1, 2014

First QC Date

February 10, 2006

Last Update Submit

June 5, 2014

Conditions

Tardive Dyskinesia

Outcome Measures

Primary Outcomes (1)

  • Abnormal Involuntary Movement Scale (AIMS) Total Score

    12 weeks

Study Arms (2)

Levetiracetram Administration

EXPERIMENTAL
Drug: levetiracetam

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

levetiracetamDRUG
Levetiracetram Administration
placeboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

Related Publications (1)

  • 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.

    PMID: 18312060DERIVED

MeSH Terms

Conditions

Tardive Dyskinesia

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Dyskinesia, Drug-InducedDyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Scott W Woods, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Primary Completion

April 1, 2006

Last Updated

June 6, 2014

Record last verified: 2014-06

Locations

US(1)