EUCTR2016-002879-96-Outside-EU/EEA进行中（未招募）1 期
An open-label, multicenter, long-term, follow-up study in Japan to evaluate the safety, tolerability, and efficacy of adjunctive treatment with oral L059 (levetiracetam) in epilepsy subjects with generalized tonic-clonic (GTC) seizures
CB Japan Co. Ltd.0 个研究点目标入组 46 人开始时间: 2016年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
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
- •Inclusion Criteria:
- •- The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
- •- The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 29
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
研究者
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