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

• Status: Completed
• Trial end date: 2003-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Etiracetam; Levetiracetam; Piracetam

Criteria

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