Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study

Kluger G, Glauser T, Krauss G, Seeruthun R, Perdomo C, Arroyo S. Adjunctive rufinamide in Lennox-Gastaut syndrome: a long-term, open-label extension study.Acta Neurol Scand: 122: 202–208.© 2010 The Authors Journal compilation © 2010 Blackwell Munksgaard. Objective – This open-label extension evaluated the long-term efficacy and tolerability of rufinamide in patients with Lennox-Gastaut syndrome (LGS) who had previously completed a 12-week double-blind study. Materials and methods – In total, 124 patients (aged 4–37 years), receiving 1–3 concomitant antiepileptic drugs, were treated with rufinamide ∼25–60 mg/kg/day. Efficacy was assessed by seizure frequency; tolerability by adverse events (AEs) and laboratory tests. Results – Overall, patients were treated with rufinamide for a median (range) of 432 (10–1149) days. Reductions in seizure frequency were observed throughout the study; during the last 12 months of treatment, 41.0% and 47.9% of patients had ≥50% reduction in total and tonic–atonic seizure frequency, respectively. The most common AEs were vomiting (30.6%) and pyrexia (25.8%). Conclusions – In this open-label extension, rufinamide appeared to be an effective long-term adjunctive therapy for the treatment of LGS-associated seizures in children and young adults.