NCT00630968已完成4 期
Trial Studying the Safety and Efficacy of Keppra® as Adjunctive Therapy in Adult Patients With Uncontrolled Partial 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
- 1,541
- 主要终点
- Percentage reduction in seizure frequency.
研究概览
简要总结
The purposes of the study were to obtain further information about the optimal dose and the efficacy of Keppra in daily clinical practice, and to confirm the favorable safety and tolerability profiles of the drug observed during clinical development.
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, whether or not secondarily generalized;
- •at least 1 partial seizure and no more than 14 partial seizures per month as measured by historic baseline;
- •using 1, but no more than 2 concomitant marketed antiepileptic drugs (AEDs) at the time of study entry.
排除标准
- •Presence of known pseudoseizures within the last year;
- •presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
- •on felbamate with less than 18 months exposure;
- •on vigabatrin, but visual field had not been assessed as per recommendation of the manufacturer, i.e., every 6 months;
- •uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.
结局指标
主要结局
Percentage reduction in seizure frequency.
时间窗: 16-week treatment period
次要结局
- To further assess safety.
- The patient-weighted Quality Of Life In Epilepsy inventory.
研究者
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