A double-blind, randomized trial of topiramate in Lennox–Gastaut syndrome

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Abstract
Objective: To evaluate the efficacy and safety of topiramate as adjunctive therapy for Lennox–Gastaut syndrome in a multicenter, double-blind, placebo-controlled trial. Background: Conventional antiepileptic drugs are frequently ineffective against multiple-seizure types of Lennox–Gastaut syndrome. Methods: Ninety-eight patients >1 year to Results: For drop attacks, the most severe seizures associated with this syndrome, the median percentage reduction from baseline in average monthly seizure rate was 14.8% for the topiramate group and −5.1% (an increase) for the placebo group (p = 0.041). Topiramate-treated patients demonstrated greater improvement in seizure severity than did placebo-treated patients based on parental global evaluations (p = 0.037). The percentage of patients with a ≥50% reduction from baseline in major seizures (drop attacks and tonic-clonic seizures) was greater in the topiramate group (15/46 or 33%) than in the control group (4/50 or 8%; p = 0.002). The most common adverse events in both groups were CNS related; there were no discontinuations from topiramate therapy due to adverse events. Conclusions: Topiramate adjunctive therapy was effective in reducing the number of drop attacks and major motor seizures and in improving seizure severity as determined by parental global evaluation.