Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

Phase 2

Completed

• Conditions: Dyskinesia, Medication-induced

• Registration Number: NCT00175955
• Lead Sponsor: UCB Pharma

Brief Summary

An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2009-09
• Last Update Submitted: 2013-12-05
• Last Update Posted: 2013-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Subjects between ages 18 and 80 years
• Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening
• Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria
• Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening

Exclusion Criteria

• Presence of any axis II condition within 6 months prior to screening
• Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia
• Start of drugs-other than neuroleptics- that can cause dyskinesia
• Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period

Secondary Outcome Measures

Name	Time	Method
Neuroleptic-induced akathisia and other extrapyramidal symptoms ,
Effect on the primary psychiatric disorder
Safety