トビラマトト(KW-6485)の症候性局在関連性てhかhに対する第Ⅲ相臨床試験 プラセボを対照とした二重盲検並行群間比較試験

摘要

Topiramate ((-) -2, 3:4, 5-Di-O-isopropylidene-beta-D-fructopyranose sulfamate] is a novel antiepileptic agent classified as a sulfamate-substituted monosaccharide.A double-blind, placebo-controlled comparative study was conducted to evaluate the efficacy and safety of topiramate (KW-6485) administered to patients with symptomatic localization-related epilepsy receiving one or two other antiepileptic drugs at therapeutic concentrations. We obtained the following results 1) Out of 159 patients enrolled during the baseline period, 32 were excluded before starting the study drug because of violation of the inclusion/exclusion criteria and other reasons. The study drug was administered to 127 patients randomized into two groups (62 treated with topiramate and 65 with placebo). All patients who received the study drug were analyzed for safety and 126 excluding 1 who was later found to violate the inclusion criteria were analyzed for efficacy (61 treated with topiramate and 65 with placebo).