An Open Label, Multicenter, Safety and Pharmacokinetic Study of YKP3089 as Adjunctive Therapy in Subjects With Partial Onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,345
- 试验地点
- 121
- 主要终点
- Summary of Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
This is a multicenter, open label study to assess the safety and pharmacokinetics of YKP3089 as adjunctive therapy in subjects with partial onset seizures. Initially, subjects taking phenytoin or phenobarbital will be enrolled followed by additional subjects taking anti-epileptic drugs (AED) other than phenytoin and phenobarbital to further investigate long-term safety.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
YKP3089
Multiple dose
干预措施: YKP3089 (Drug)
结局指标
主要结局
Summary of Treatment-Emergent Adverse Events (TEAEs)
时间窗: 1 day to up to 215 weeks after first dose.
TEAEs were defined as Adverse events (AEs) with onset on or after the start of study medication, up to last dose date of study medication + 14 days or onset before study medication and worsened after starting study medication, up to last dose date of study medication + 14 days.
次要结局
未报告次要终点