Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biocodex
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- management of the Dravet syndrome
研究概览
简要总结
The present study aims to collect data regarding the history of the disease, previous and current treatments, and the clinical status of Dravet patients during the 3 months prior to stiripentol initiation, the first 3 months on stiripentol and the last 3 months on stiripentol (irrespective of stiripentol discontinuation).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Dravet syndrome
- •Treated with stiripentol for a minimum of 3 months in routine practice
排除标准
- 未提供
结局指标
主要结局
management of the Dravet syndrome
时间窗: through study completion, an average of 1 year
Patient Information History of the Disease Clinical status of the patient during the 3 months preceding stiripentol treatment initiation Clinical status of the patient at stiripentol initiation Clinical status of the patient during the first 3 months of stiripentol treatment Clinical status of the patient during the last 3 months of stiripentol treatment Evolution on stiripentol
次要结局
- Better detection of the Dravet syndrome(through study completion, an average of 1 year)