Abstracts

RATIONALE: Rufinamide is an antiepileptic drug (AED) that reduced seizure frequency in patients with epilepsy in two previous clinical studies. We present here the results of the first phase III study of rufinamide as adjunctive therapy in the treatment of adults with therapy-resistant partial-onset seizures. METHODS: Three hundred-thirteen patients were randomized to rufinamide (3200 mg/day) or placebo in this 91-day double-blind parallel-group study. Patients were 16-72 years old, had a minimum of six partial seizures during the 56-day baseline and received 1-2 fixed-dose concomitant AEDs during baseline and treatment. RESULTS: Rufinamide-treated patients had a 20.4% median reduction in partial seizure frequency (treatment relative to baseline) while placebo-treated patients had a 1.6% median increase (p=0.0158). The 50% responder rate also showed a significant difference in favor of the rufinamide treatment group (p=0.0381). Adverse events that showed the greatest difference relative to placebo were dizziness, nausea, headache, and diplopia. These adverse events most commonly occurred during titration, were transient and mild to moderate in severity. There were no clinically relevant changes in vital signs, ECGs or laboratory parameters relative to baseline. CONCLUSIONS: Data from this, the third positive study of rufinamide in the treatment of therapy-resistant partial seizures in adults, further confirms rufinamide's efficacy and safety. Studies in additional populations and indications are ongoing.