An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.

UCB Pharma0 sites70 target enrollmentMay 2005

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Dyskinesia, Medication-induced
Sponsor: UCB Pharma
Enrollment: 70
Primary Endpoint: Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period
Status: Completed
Last Updated: 12 years ago

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

Registry

clinicaltrials.gov

Start Date

May 2005

End Date

December 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

•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

•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