NCT01086501已完成不适用
Efficacy and Safety of an ER-formulation of Oxcarbazepine (Apydan Extent) in Epileptic Patients Under Consideration of Quality of Life Parameters
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- tolerability and safety
研究概览
简要总结
The aim of the observational study is to investigate the safety of oxcarbazepine extended release (ER) during long-term therapy in epileptic patients. In addition, quality of life parameters should be documented if assessed.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with focal epileptic seizures with or without secondary generalised tonic-clonic seizures
- •mono- or combination therapy
- •male and female from the age of 6
排除标准
- •hypersensitivity to oxcarbazepine MR or one of its excipients
结局指标
主要结局
tolerability and safety
时间窗: 12 months per patient
次要结局
未报告次要终点
研究者
研究点 (1)
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