Abstracts

Despite the worldwide introduction of numerous antiepileptic drugs (AEDs) over the past 15 years, significant numbers of pediatric patients with epilepsy continue to suffer with uncontrolled seizures. Based on efficacy of rufinamide in adults with partial seizures, this study aimed to assess the efficacy and safety of rufinamide as adjunctive therapy in pediatric patients with inadequately controlled partial seizures. This randomized, double-blind, placebo-controlled, adjunctive therapy trial enrolled 269 pediatric patients (4 to [lt]16 years) diagnosed with uncontrolled partial seizures who were taking stable dosages of 1 or 2 other AEDs. Following a 56-day baseline phase (BP), patients were randomized to either rufinamide or placebo adjunctive therapy; dosages were titrated to 45 mg/kg per day over 14 days, followed by a 77-day maintenance period. The primary efficacy measure was the percent change in partial seizure frequency per 28 days relative to BP. Secondary efficacy variables included: total partial seizure frequency per 28 days, and response to treatment, defined as a [ge]50% reduction in the partial seizure frequency per 28 days. A total of 268 patients received study medication. Mean reduction in partial seizure frequency per 28 days was not significantly different between rufinamide and placebo (7.0% vs 12.8% respectively; [italic]p[/italic]=0.621). Secondary efficacy variables for seizure frequency showed trends favoring rufinamide; the median total partial seizure frequency per 28 days was 11.7 vs 14.0 for rufinamide and placebo, respectively ([italic]p[/italic]=0.082), and 27.2% vs 18.3% of rufinamide and placebo patients, respectively, experienced a [ge]50% reduction in partial seizure frequency ([italic]p[/italic]=0.060). The most commonly reported adverse events (AEs) were mild to moderate in severity and included headache (rufinamide, 19.1%, vs placebo, 9.8%), somnolence (14.7% vs 8.3%), vomiting (13.2% vs 6.1%), and upper respiratory tract infection (6.6% vs 11.4%). Ten rufinamide patients (7.4%) and 4 placebo patients (3.0%) prematurely discontinued the study due to AEs. Nonfatal serious AEs were reported in 10 rufinamide-treated patients (7.4%) and 9 placebo-treated patients (6.8%). Rufinamide was well tolerated in pediatric patients at a dosage of 45 mg/kg per day. This study did not demonstrate the efficacy of adjunctive rufinamide therapy for pediatric partial seizures. (Supported by Eisai Inc.)