NCT01983722Approved For Marketing不适用
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 试验地点
- 1
研究概览
简要总结
Expanded access to Stiripentol for patients with Dravet Syndrome.
详细描述
This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •6 months and older
- •Diagnosis of Dravet Syndrome with intractable seizures
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Past history of psychoses in the form of episodes of delirium
- •Impaired hepatic and/or renal function, defined as creatinine >2 and/or transaminase >4xULN
研究者
研究点 (1)
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