Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

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.

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

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