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

Acta Neurol Scand. 2010 Sep;122(3):202-8. doi: 10.1111/j.1600-0404.2010.01334.x. Epub 2010 Mar 1.


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 approximately 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 > or = 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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Anticonvulsants / therapeutic use*
  • Child
  • Child, Preschool
  • Double-Blind Method
  • Drug Evaluation
  • Drug Therapy, Combination / methods
  • Epilepsy / drug therapy*
  • Female
  • Humans
  • Longitudinal Studies
  • Male
  • Treatment Outcome
  • Triazoles / therapeutic use*
  • Young Adult


  • Anticonvulsants
  • Triazoles
  • rufinamide