Abstracts

The primary objective of this study was to assess the efficacy and safety of rufinamide as adjunctive therapy compared to placebo in adult patients with inadequately controlled partial seizures. Adult patients (aged [ge]16 years) with partial seizures, and who were taking stable doses of 1 or 2 other antiepileptic drugs (AEDs), were enrolled in this multicenter, double-blind, placebo-controlled, randomized, parallel-group study. During the 56-day baseline phase (BP), patients must have had [ge]6 partial seizures. In the 91-day double-blind phase (DB) patients were randomized to rufinamide or placebo. The study drug was titrated to 3200 mg/d and maintained for 77 days. Primary efficacy was evaluated by the percent change in partial seizure frequency per 28 days of DB from the BP. Secondary efficacy was evaluated by the percentage of treatment responders (patients with [ge]50% reduction in partial seizure frequency). Adverse events (AEs) were monitored to assess the safety of rufinamide. A total of 313 adult patients were randomized (rufinamide, n=156; placebo, n=157). Rufinamide-treated patients experienced a 20.4% median reduction in partial seizures per 28 days relative to baseline compared to 1.6% median increase in placebo-treated patients ([italic]p[/italic]=0.0158). Additionally, a significantly higher percentage of rufinamide-treated patients (28.2%) were treatment responders compared to placebo patients (18.6%, [italic]p[/italic]=0.0381). The most commonly reported AEs for rufinamide-treated patients vs placebo (incidence [ge]10% in either treatment group) included dizziness (42.3% vs 14.0%), headache (37.8% vs 24.2%), nausea (26.3% vs 11.5%), somnolence (20.5% vs 12.1%), diplopia (19.9% vs 3.2%), fatigue (16.0% vs 8.3%), ataxia (13.5% vs 0.6%), vomiting (13.5% vs 4.5%), abnormal vision (10.9% vs 1.9%), and viral infection (10.3% vs 13.4%). Nonfatal, serious AEs were experienced by 6 rufinamide-treated patients and 4 placebo patients. Twenty-two rufinamide-treated patients and 5 placebo patients discontinued due to AEs or a laboratory abnormality. Rufinamide (3200 mg/d) was generally well tolerated and effective as adjunctive therapy for adult patients with inadequately controlled partial seizures. (Supported by Eisai Inc.)