NCT01398956已完成3 期
An Open-label, Multicenter, Long-term, Follow-up Study in Japan to Evaluate the Safety, Tolerability, and Efficacy of Adjunctive Treatment With Oral L059 (Levetiracetam) in Epilepsy Subjects With Generalized Tonic-clonic (GTC) 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
- 44
- 试验地点
- 32
- 主要终点
- Incidence of Treatment Emergent Adverse Events During the Entire Study Period
研究概览
简要总结
The investigators will provide Levetiracetam treatment to epilepsy subjects in Japan who are judged to benefit from continued treatment with Levetiracetam by the investigators and who are willing to continuously receive this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject in Japan has completed either of the studies N01159 or N01363 or has discontinued the N01159 study due to lack of efficacy.
- •The subject who is judged to benefit from continued treatment with Levetiracetam by the investigators
排除标准
- •Subjects with multiple protocol deviations during N01159 or N01363, such as missing laboratory data, and low or noncompliance with the study medication, and who the investigator considers not to have the potential to have deviations stopped are ineligible
研究组 & 干预措施
Levetiracetam
Experimental
Twice daily (morning and evening) orally
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events During the Entire Study Period
时间窗: Through study completion, an average of 3 years
次要结局
- The Percentage Change in Generalized Tonic-Clonic (GTC) Seizure Frequency Per Week Over the Evaluation Period From Either of the Combined Baseline Periods of the Previous Studies (N01159 or N01363).(During the Treatment Period (up to 4.8 years))
- The Incidence of Adverse Drug Reactions During the Entire Study Period(Through study completion, an average of 3 years)
研究者
研究点 (32)
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