Levetiracetam Treatment of Tardive Dyskinesia | NCT00291213

Studies
Levetiracetam Treatment of Tardive Dyskinesia

NCT00291213

Sponsor

Yale University

Status

Completed

Last Update Posted

Jun 6, 2014Estimated

Enrollment

50Actual

Phase

Phase 3

Conditions

Tardive Dyskinesia

Interventions

levetiracetam
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Apr 2006Actual

Completion Date

Not provided

First Submitted Date

Feb 10, 2006

First Submission Date that Met QC Criteria

Feb 10, 2006

First Posted Date

Feb 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2014

Last Update Posted Date

Jun 6, 2014Estimated

Name	Class
UCB Pharma	INDUSTRY

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Levetiracetram Administration	Experimental		Drug: levetiracetam
Placebo	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
levetiracetam	Drug		Levetiracetram Administration
placebo

Measure	Description	Time Frame
Abnormal Involuntary Movement Scale (AIMS) Total Score		12 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria: meet Glazer Morgenstern criteria for TD -

Exclusion Criteria: none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Scott W Woods, MD	Yale University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Connecticut Mental Health Center		New Haven	Connecticut	06519	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18312060	Derived	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.

ID	Term
D004409	Dyskinesia, Drug-Induced
D020820	Dyskinesias
D009069	Movement Disorders
D002493	Central Nervous System Diseases

ID	Term
D000081	Acetamides
D000577	Amides
D009930	Organic Chemicals
D000085	Acetates
D000144