NCT00630357已完成4 期
A Phase IV, Open-label, Multi-center Trial to Evaluate the Safety and Efficacy of Keppra® After Conversion to Mono-therapy in Adult Subjects With 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
- 14
- 主要终点
- Investigate seizure freedom with Keppra flexible dose.
研究概览
简要总结
A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.
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
- •Diagnosis of epilepsy with partial seizures;
- •having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
- •seizure-free over the last 3 months prior to protocol Visit 1;
- •1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
- •on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.
排除标准
- •History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
- •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;
- •felbamate with less than 18 months exposure;
- •vigabatrin, without visual field assessment 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
Investigate seizure freedom with Keppra flexible dose.
次要结局
- Tolerability and safety.
研究者
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