JPRN-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
CB Japan Co., Ltd.0 个研究点目标入组 411 人开始时间: 2019年1月10日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 411
研究概览
简要总结
The primary efficacy variable, the change in observable focal-onset seizure frequency from Baseline over the 12-week Maintenance Period, was not statistically significant compared with placebo in any PSL dose group. Overall, PSL was generally well tolerated and the safety profile was as expected, based on the pharmacology of the AED, and was consistent with previous experience with PSL.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) 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)
- •2) 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).
- •3) Subjects having on average 4 and more spontaneous and observable focal-onset seizures per 28 days.
排除标准
- •1) Subject has a history of or signs of generalized or combined generalized and focal epilepsy
- •2) Subject has a history of status epilepticus within the 6-month period prior to Screening Visit (Visit 1).
- •3) 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.
- •4) Subject is currently treated with carbamazepine, phenytoin, primidone, or phenobarbital.
研究者
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