A double-blind, randomized trial of topiramate in Lennox-Gastaut syndrome. Topiramate YL Study Group.

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 <30 years of age, with slow spike-and-wave patterns on EEG, seizure types including drop attacks, and either a history of or active atypical absence seizures, were assigned to an 11-week, double-blind treatment phase with either topiramate or placebo. Topiramate was titrated to target doses of approximately 6 mg/kg/d.

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 > or = 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.

• Authors: R C Sachdeo, T A Glauser, F Ritter, R Reife, P Lim, G Pledger
• Journal: Neurology (Neurology) Vol. 52 Issue 9 Pg. 1882-7 (Jun 10 1999) ISSN: 0028-3878 [Print] United States
• PMID: 10371538 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Anticonvulsants
• Topiramate
• Fructose

Topics

• Adolescent
• Anticonvulsants (adverse effects, therapeutic use)
• Child
• Child, Preschool
• Double-Blind Method
• Epilepsy (drug therapy)
• Female
• Fructose (adverse effects, analogs & derivatives, therapeutic use)
• Humans
• Male
• Topiramate