A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 130
- 主要终点
- Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
研究概览
简要总结
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe.
To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.
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
- •Male/female adult subjects (≥ 16 or 18 years)
- •Diagnosis of epilepsy (all types of seizures may be included)
- •Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy
- •Other inclusion criteria may apply
排除标准
- •Subjects withdrawn from N01175 (NCT00175903) trial for any reason
- •Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial
- •Subject requiring add-on antiepileptic treatment
- •Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment
- •Sexually active woman with childbearing potential who is not using a medically accepted birth control method
研究组 & 干预措施
Levetiracetam (LEV)
干预措施: Levetiracetam (Drug)
结局指标
主要结局
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase
时间窗: during open-label therapy phase of 18 months
Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).
次要结局
- Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months(Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months)