Multicenter randomized, double-blind, placebo-controlled trial of zonisamide as add-on therapy in patients with refractor partial seizures
10.3760/cma.j.issn.1006-7876.2009.04.013
- VernacularTitle:多中心、随机、双盲、安慰剂对照评价唑尼沙胺添加治疗癫(癎)部分性发作的疗效和安全性
- Author:
Peimin YU
;
Guoxing ZHU
;
Dongyan WU
;
Zhongxin ZHAO
;
Shengdi CHEN
;
Liwen WU
;
Meiping DING
;
Dexin WANG
;
Liemin ZHOU
;
Xuefeng WANG
;
Dong ZHOU
;
Zhen HONG
- Publication Type:Journal Article
- Keywords:
Epilepsies,partial;
Isoxazoles;
Anticonvulsants;
Randomized controlled trial
- From:
Chinese Journal of Neurology
2009;42(4):263-267
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the efficacy and tolerability of zonisamide (ZNS) as add-on therapy in patients with refractory partial seizures.Methods In this Chinese muiticenter, double-blind, randomized, placebo-contrclled trial, ZNS was compared with placebo add-on therapy in 217 patients (intent-to treat (ITT) population) with uncontrolled partial-onset seizures.All patients entered a 3-month baseline period followed by a 4-week titration interval and a 12-week maintenance period.The starting dose of ZNS group was 100 mg/d, increased by 100 mg/d every week and reached the goal of 400 mg/d.The main outcome was measured by the median of the percentage of decreased seizure frequency.The secondary ouwomes points included the percentage of patients who had seizure attacks decreased by more than 50%,and adverse events.Results The median of the percentage of decreased seizure frequency in ZNS group was 33.33%, and the placebo group was 0.Thirty-eight patients (34.23%) experienced more than 50% reduction in the seizure frequency in ZNS group, compared with 19.81% of patients (21 cases) in the placebo group (χ2 =5.7159,P =0.0168) ; Moreover, 13 (11.71%) patients in ZNS group and 5 patients in placebo group were seizure free, 25 patients in ZNS group and 16 patients in placebo group who had seizure attacks decreased by more than 50%.The availability rate in ZNS group was higher than placebo group (34.23% vs 19.81%, U=2.4701, P=0.0135).The most common adverse events in ZNS group were drowsiness, fatigue, decreased appetite, gastrointestinal complaints, insomnia and constipation.Conclusion Zonisamide treatment was generally well tolerated and was associated with significant reductions in seizure frequency as adjunctive treatment for partial-onset seizures.
