Abstract
Objective: This was a phase-II, randomized, double-blind, placebo-controlled study aimed to evaluate ESL effect on cognition in children with partial-onset-seizures (POS). Efficacy and tolerability of ESL in comparison with placebo was also evaluated. Methods: Patients (6–16 years) with POS (≥2 in the month before enrolment), receiving one-two antiepileptic-drugs (except oxcarbazepine), were randomized to ESL or placebo (2:1). ESL was titrated from 10 to 20 mg/kg/day over 4-weeks. If no intolerable AEs occurred, patients were up-titrated to 30 mg/kg/day (maximum 1200 mg/day) maintained for 8-weeks. Down-titration was allowed only once. Primary endpoint was the change from baseline in composite Power of Attention (PA) measure. Efficacy was assessed as relative reduction in standardized-(/4 week)-seizure-frequency (SF), proportion-of-responders (≥50% SF-reduction) and proportion of seizure-free patients (100% seizure reduction) from baseline. Safety/tolerability included incidence of treatment-emergent AEs (TEAEs). Results: Seventy-five (90%) ESL and 37 (93%) placebo patients completed the trial. Mean SF relative change was −9% for placebo and −31% for ESL (p<0.001). Responders were 25% for placebo and 51% for ESL (p=0.009). The proportion of seizure-free patients was 5% for placebo and 22% for ESL (p=0.024). Overall incidence of TEAEs was similar (45% for ESL and 48% for placebo). Most frequently reported TEAEs were headache, somnolence and vomiting. Conclusions: In children with POS, adjunctive ESL treatment was efficacious, well tolerated and no new or unexpected safety findings emerged.
Published Version
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