jRCT2080224509已完成2 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PADSEVONIL AS ADJUNCTIVE TREATMENT OF FOCAL-ONSET SEIZURES IN ADULT SUBJECTS WITH DRUG-RESISTANT EPILEPSY
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in log transformed observable focal onset seizure frequency
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Subject fulfills diagnostic criteria for epilepsy and has observable focal-onset (IA1, IB, and IC) seizures for at least 3 years at the time of enrolment (according to the ILAE Classification of Epileptic Seizures, 1981)
- •Subject is currently treated with an individually optimized and stable dose of at least 1 and up to 3 AEDs for the 8 weeks prior to the Screening Visit (Visit 1).
- •Subjects having on average 4 and more spontaneous and observable focal-onset seizures per 28 days.
排除标准
- •Subject has a history of or signs of generalized or combined generalized and focal epilepsy
- •Subject has a history of status epilepticus within the 6-month period prior to Screening Visit (Visit 1).
- •Subject has seizures on a regular basis that are uncountable eg due to clustering during the 8-week retrospective Baseline and during the 4-week Baseline Period.
- •Subject is currently treated with carbamazepine, phenytoin, primidone, or phenobarbital.
结局指标
主要结局
change in log transformed observable focal onset seizure frequency
时间窗: 12-week Maintenance Period
Efficacy variable is the change in log transformed observable focal onset seizure frequency from Baseline
次要结局
- The 75% responder rate(over the 12-week Maintenance Period)
研究者
研究点 (1)
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