title: Double-blind, placebo-controlled study of topiramate in patients with refractory partial epilepsy.
abstract: The efficacy and safety of topiramate 400 mg/day as adjunctive therapy to traditional antieleptic drugs for partial onset seizures with or without secondary generalization were assessed in a double-blind, parallel-group, placebo-controlled trial. Forty-seven patients with at least one seizure per week during an 8 week baseline were randomly assigned to topiramate (N = 23) or placebo (N = 24) double-blind treatment for a 3 week titration and an 8 week stabilization period. Median percent reduction from baseline in monthly seizure frequency during the double-blind phase was not significantly greater in the topiramate group than in the placebo group (41% vs. 1%; P = 0.065). Nevertheless, other efficacy variables evidenced statistically significant differences in favor of topiramate: a greater number of treatment responders (> or = 50% reduction in seizures; 35% vs. 8%; P = 0.033); better investigator (P = 0.002) and patient (P = 0.021) global assessments; and greater reductions in secondarily generalized seizures compared to placebo (P = 0.002). The most commonly reported topiramate treatment-emergent adverse events were somnolence, fatigue, abnormal vision, weight decrease, and anxiety. Most adverse events were mild or moderate in severity. Among 7 withdrawals due to limiting adverse events, 6 were CNS-related (in 5 topiramate-treated patients). Results of this trial strongly suggest that topiramate 400 mg/day is effective and well tolerated in the treatment of refractory partial epilepsy.
authors.affiliation: Institute of Neurology, London, UK.
authors.forename: M
authors.initials: M
authors.lastname: Sharief
authors.forename: C
authors.initials: C
authors.lastname: Viteri
authors.forename: E
authors.initials: E
authors.lastname: Ben-Menachem
authors.forename: M
authors.initials: M
authors.lastname: Weber
authors.forename: R
authors.initials: R
authors.lastname: Reife
authors.forename: G
authors.initials: G
authors.lastname: Pledger
authors.forename: R
authors.initials: R
authors.lastname: Karim
mesh_terms: D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005060:Europe; D005260:Female; D005632:Fructose / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D000077236:Topiramate
chemical_list: D000927:Anticonvulsants; D010919:Placebos; D000077236:Topiramate; D005632:Fructose