A Multi-center, Double-blind, Historical Control, Randomized Conversion to Monotherapy Study With Keppra XR for Treatment of Partial Onset Seizures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 228
- 主要终点
- The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
研究概览
简要总结
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 12 to 75 years of age.
- •Subjects must have inadequately controlled partial onset epilepsy.
- •Subjects must be experiencing 2 to 40 seizures per 4-week period while being maintained on one or two standard AED(s)
排除标准
- •A history of status epilepticus in the 6 months preceding randomization.
- •Significant medical, psychiatric or neurological illness.
- •Intake of benzodiazepines on more than an occasional basis
- •History of previous treatment with levetiracetam or sensitivity to levetiracetam.
研究组 & 干预措施
Keppra XR 1000 mg/day
1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily)
干预措施: Keppra XR (Drug)
Keppra XR 2000 mg/day
2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
干预措施: Keppra XR (Drug)
结局指标
主要结局
The Cumulative Exit Rate at 112 Days After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase
时间窗: 112 days
Cumulative exit rate at day 112, based on the duration between start date of previous AED tapering to the earliest date exit criterion was met; calculated using Kaplan Meier Methods. Subjects prematurely discontinued for reasons unrelated to exit criteria were censored as of last dose of study drug. Subjects who completed without meeting exit criteria were censored at Day 112. Exit criteria include increase in seizure frequency, severity, duration, status epilepticus, or new generalized seizure. Upper 95% 2-sided confidence limit for exit rate is compared to the historical control rate: 0.678.
次要结局
- The Cumulative Rate of Exit Events, Which Include Discontinuation Due to Exit Criteria, Withdrawal Due to Adverse Events (AE) and Withdrawal Due to Lack of Efficacy, at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase(112 days)
- The Cumulative Rate of Exit Events Due to Any Reasons at 112 Days After the Beginning of Previous Antiepileptic Drug (AED) Tapering Phase(112 days)
- The Cumulative Exit Rate at 112 Days for the Keppra XR 1000 mg Group After the Beginning of the Previous Antiepileptic Drug (AED) Tapering Phase(112 days)