EUCTR2014-004333-57-Outside-EU/EEA进行中（未招募）不适用
A Double-blind, Randomized, Placebo-controlled 5 Parallel Groups, Confirmatory Trial on the Efficacy and Safety of Levetiracetam used as add-on Therapy at doses of 0.5 to 3 g/day in Patients From 16 to 65 Years With Epilepsy With Partial Onset Seizures Under Treatment With 1 to 3 Anti-epileptic Drug(s)
CB Japan Co., Ltd.0 个研究点目标入组 352 人开始时间: 2015年2月10日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 352
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Subjects aged from 16 to 65 years at the acquisition of informed consent to the trial participation
- •- Seizure type: subjects with epileptic seizures which were diagnosed as partial seizures more than 2 years ago according to Clinical and electroencephalographic classification of epileptic seizures (1981)” defined by the International League Against Epilepsy (ILAE) and confirmed with an EEG that has been performed within 1 year before Screening or at the Screening Visit
- •- Subjects whose previous therapy before screening involved at least two standard anti-epileptic drugs (AEDs) for partial seizures, and in whom it can be confirmed that the doses met the daily dose specified for the treatment of epilepsy in the package insert and that the therapy has been continued for at least 3 months
- •- Frequency of epileptic seizures: subjects experiencing partial seizures at least 12 times in 12 weeks during the Baseline Period (Week -12 to Week 0) and at least twice in every 4 weeks
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 340
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •- Subjects who were diagnosed with status epilepticus within 3 months before screening
- •- Subjects with no partial seizures of which frequency was measured during the Baseline Period
- •- Subjects who underwent surgery for epilepsy within 2 years before Screening or who were scheduled to undergo brain surgery during the study period and within 4 weeks after the completion of this study
- •- Subjects with a history of oral treatment with Levetiracetam (LEV)
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