NCT00175851撤回3 期
An Open-label, Multicenter, Follow-up Trial to Evaluate the Long-term Safety and Efficacy of Seletracetam Used as Adjunctive Treatment Using a Flexible Dosing Scheme of 4 to 80 mg b.i.d. in Subjects Aged 16 Years or Older Suffering From Epilepsy
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- UCB Pharma
- 主要终点
- Safety profile of seletracetam
研究概览
简要总结
This is a safety and efficacy study of add-on therapy with seletracetam in epilepsy patients who have participated in a previous seletracetam study
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •A signed and dated IRB/IEC approved written informed consent form
- •Male/female age 18 years (16 years where permitted) to 65 years
- •Minimum body weight of 40 kg
- •Patients having participated in a previous seletracetam study
- •Female patients without childbearing potential or using a medically accepted non-hormonal contraceptive method are eligible.
排除标准
- •Ongoing psychiatric disease other than mild controlled disorders
- •Subject with clinically significant abnormalities in laboratory tests or ECG
- •Poor compliance with visit schedule or medication intake in a previous seletracetam study
- •Subject taking part in another clinical/pharmacological study, with the exception of seletracetam studies, in the 30 days preceding enrollment
结局指标
主要结局
Safety profile of seletracetam
次要结局
- Reduction in seizure frequency
研究者
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