NCT00150813已完成3 期
A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Percentage Participants With Treatment Emergent Adverse Events
研究概览
简要总结
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
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
- •Subjects with a confirmed diagnosis of epilepsy.
- •Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
- •Subjects having participated in the previous double-blind monotherapy trial (N01061 [NCT00150735] or N01093 [NCT00150787]).
- •Male/female subjects (>= 16 years).
排除标准
- •Need for an additional Antiepileptic Drug (AED).
研究组 & 干预措施
Levetiracetam
Experimental
Subjects received open-label Levetiracetam.
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Percentage Participants With Treatment Emergent Adverse Events
时间窗: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
次要结局
未报告次要终点
研究者
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