Author(s): Glauser T, Kluger G, Sachdeo R, Krauss G, Perdomo C,
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Abstract BACKGROUND: Lennox-Gastaut syndrome is a catastrophic pediatric epilepsy syndrome characterized by multiple types of treatment-resistant seizures and high rates of seizure-related injury. Current available treatments are inadequate, leaving patients with few treatment options and opportunities. METHODS: We conducted a double-blind, randomized, placebo-controlled trial of the antiepileptic drug rufinamide in patients with Lennox-Gastaut syndrome. Eligible patients between 4 and 30 years of age had multiple types of seizures (including tonic-atonic and atypical absence seizures) with a minimum of 90 seizures in the month before baseline and a recent history of a slow spike-and-wave pattern on EEG. RESULTS: After a 28-day baseline period, 139 eligible patients were randomized; 138 patients received either rufinamide (n = 74) or placebo (n = 64) in addition to their other antiepileptic drugs. The median percentage reduction in total seizure frequency was greater in the rufinamide therapy group than in the placebo group (32.7\% vs 11.7\%, p = 0.0015). There was a difference (p < 0.0001) in tonic-atonic ("drop attack") seizure frequency with rufinamide (42.5\% median percentage reduction) vs placebo (1.4\% increase). The rufinamide group had a greater improvement in seizure severity (p = 0.0041) and a higher 50\% responder rate compared with placebo for total seizures (p = 0.0045) and tonic-atonic seizures (p = 0.002). The common adverse events (reported by >or=10\% of patients receiving rufinamide) were somnolence (24.3\% with rufinamide vs 12.5\% with placebo) and vomiting (21.6\% vs 6.3\%). CONCLUSIONS: Rufinamide was an effective and well-tolerated treatment for seizures associated with Lennox-Gastaut syndrome.
This article was published in Neurology
and referenced in International Journal of Neurorehabilitation