Status:
COMPLETED
Efficacy and Tolerability of Levetiracetam Add-On Treatment in Refractory Pediatric Patients With Partial Onset Seizures
Lead Sponsor:
UCB Pharma
Conditions:
Epilepsy
Eligibility:
All Genders
4-16 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00615615
Start Date
September 1 1999
End Date
March 1 2003
Last Update
July 30 2020
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