NCT00631150已完成4 期
A Phase IV-Pharmacovigilance Study of Keppra Greece - S.K.A.T.E.: Safety of Keppra as Adjunctive Therapy in Epilepsy
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 35
- 主要终点
- Safety and the tolerability of Keppra in a broad population of patients.
研究概览
简要总结
Patients in community-based practices correspond to the 25% of patients who need a first add-on drug when not controlled by their standard monotherapy drug. This was a therapeutic use trial in which the population corresponds more closely to that seen in daily clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •partial onset seizures with or without secondary generalisation with epilepsy.
排除标准
- •hypersensitivity to levetiracetam or other pyrrolidone derivatives or to any of the excipients.
结局指标
主要结局
Safety and the tolerability of Keppra in a broad population of patients.
次要结局
- Obtain further information about optimal daily dose.
研究者
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