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

UCB

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Placebo; Drug: Levetiracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT00615615

N159

Details and patient eligibility

About

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.

Enrollment: 216 patients

Sex: All

Ages: 4 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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216 participants in 2 patient groups, including a placebo group

Levetiracetam (LEV)

Experimental group

Description:

LEV dose was titrated to a level of 60 mg/kg/day. The initial dose level was 20 mg/kg/day for the first two weeks, followed by a dose level of 40 mg/kg/day for two weeks. If lower doses were well tolerated, the LEV dose was increased to a dose level of 60 mg/kg/day for the remaining 10 weeks. The dose level could be reduced to 40 mg/kg/day if the patient did not tolerate LEV at a dose level of 60 mg/kg/day.

Treatment:

Drug: Levetiracetam

Placebo

Placebo Comparator group

Description:

Subjects received Placebo matching to LEV treatment.

Treatment:

Drug: Placebo