Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures

Evaluation of the Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures: A 28-Week Double-Blind, Placebo-Controlled Multi-center Trial

Double-blind, randomized, placebo-controlled, multi-center clinical trial conducted to evaluate levetiracetam as adjunctive therapy in children (4-16 years) with refractory partial onset seizures.

Inclusion Criteria:

• diagnosis of epilepsy with uncontrolled partial onset seizures, whether or not secondarily generalized, and the diagnosis was >= 6 months before the Selection Visit
• epilepsy was classifiable according to the ILAE Classification
• >= 4 partial onset seizures during the 4 weeks preceding the Selection Visit and were required to have >= 4 partial onset seizures during each 4-week interval of the Baseline Period to qualify for randomization
• unsatisfactory current AED treatment in terms of efficacy and/or safety
• stable AED treatment consisting of no more than two AEDs

Exclusion Criteria:

• treatable seizure etiology
• epilepsy secondary to a progressive cerebral disease or any other progressively neurodegenerative disease, including Rasmussen and Landau-Kleffner diseases
• history of status epilepticus which required hospitalization during 3 months prior to the Selection Visit
• history of or the presence of pseudo seizures
• current diagnosis of Lennox-Gastaut syndrome