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临床试验/NCT01140867
NCT01140867已完成4 期

A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Zonisamide as Adjunctive Therapy in Patients With Uncontrolled Partial Epilepsy

Eisai Korea Inc.10 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2008年2月29日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
121
试验地点
10
主要终点
Seizure Reduction Rate

研究概览

简要总结

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy.

详细描述

The object of this study is to assess the efficacy and safety of zonisamide as adjunctive therapy in patients with uncontrolled partial epilepsy. Subject takes zonisamide for 16 weeks (4 weeks-titration period, 8 weeks maintenance period). Dose range of zonisamide is 100 ~ 400 mg/day and target dose is 300 mg/day. After 16 weeks, zonisamide efficacy is measured by seizure reduction rate (Each type of seizure: simple partial seizures [SPS], complex partial seizures [CPS], simple partial seizures evolving into generalized tonic-clonic convulsions [SGTC] and total seizure frequency), seizure free rate, responder rate, quality of life in epilepsy (QOLIE-31) and investigator's global evaluation scale. Safety of zonisamide in this study will be estimated by adverse event profile, retention rate and dose of exposure. The duration of this clinical study is 2 years including period of subject enrollment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

1

Experimental

干预措施: zonisamide (Drug)

结局指标

主要结局

Seizure Reduction Rate

时间窗: Baseline and 16 weeks

The percentage of the seizure reduction after Zonisamide treatment comparing baseline seizure frequency.

次要结局

  • Seizure Free Rate(16 weeks)
  • Responder Rate(Baseline and 16 weeks)
  • QoL-QOLIE31 (Quality of Life in Epilepsy)(Baseline and 16 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (10)

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