NCT00368069已完成3 期
A Double-blind, Placebo-controlled, Randomized Efficacy and Safety Study of Keppra® Extended Release Formulation - XR Once Daily as add-on Therapy in Subjects From 12 to 70 Years With Refractory Epilepsy Suffering From Partial Onset Seizures.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 158
- 试验地点
- 34
- 主要终点
- Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
研究概览
简要总结
This is a safety and efficacy study of Keppra® extended release formulation - XR in patients with epilepsy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a confirmed diagnosis of refractory epilepsy
- •Patients must be receiving a stable dose of 1 - 3 concomitant Anti-Epileptic Drugs (AED)
- •Female patients without childbearing potential. Female patients with childbearing potential are eligible if they use a medically accepted non-hormonal contraceptive method
排除标准
- •Seizures occurring in clusters
- •Status epilepticus within 3 months of Visit 1
- •History of non-epileptic seizures
- •Known allergic reaction or intolerance to pyrrolidine derivatives and/or excipients
- •Pregnant or lactating women. Any woman with childbearing potential who is not using a medically accepted, non-hormonal method of birth control
研究组 & 干预措施
Keppra® XR
Experimental
Keppra® extended release formulation -XR
干预措施: Keppra® extended release formulation - XR (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Partial Onset Seizure (POS) Frequency Per Week - Intention-To-Treat (ITT) Population
时间窗: Treatment period (12 weeks)
Number of POS over the treatment period standardized to 1 week period.
Partial Onset Seizure (POS) Frequency Per Week - Per Protocol (PP) Population
时间窗: Treatment Period (12 weeks)
Number of POS over the treatment period standardized to 1 week period
次要结局
- POS Seizure Frequency Per Week Over Baseline and Treatment Period(Baseline Period (8 weeks) - Treatment Period (12 weeks))
- All (Type I+II+III) Seizures Frequency Per Week(Treatment period (12 weeks))
- 50% Response in Weekly POS Frequency(Treatment period (12 weeks))
- Response in Weekly POS Frequency (Categorized Into 6 Categories According to Reduction) Over the Treatment Period of 12 Weeks(over the treatment period (12 weeks))
研究者
研究点 (34)
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