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临床试验/NCT06540378
NCT06540378已完成不适用

Stiripentol for the Treatment of Refractory Status Epilepticus

University Hospital Marburg0 个研究点目标入组 25 人开始时间: 2013年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
主要终点
Number of participants with cessation of SE by STP

研究概览

简要总结

The investigators retrospectively analyzed all patients who were admitted to the Department of Neurology at Marburg University Hospital between 2013 and 2023 with a diagnosis of (super)-refractory status epilepticus and who received additional treatment of SE with STP. All patients who received STP during the SE were included, regardless of previous medication.

详细描述

The investigators retrospectively analyzed all patients who were admitted to the Department of Neurology, University Hospital Marburg, Germany, between 2013 and 2023 with a diagnosis of status epilepticus, who received additional treatment of SE with STP. They were able to identify 25 patients who received STP as add on therapy. All these patients suffered from RSE or SRSE. Since there was no SOP or treatment algorithm available, they have listed the individual treatment regimens in Table 2. 5 of these patients were previously published in a case series (Strzelczyk et al. 2015).

Treatment success was defined as continuous interruption of the SE. Descriptive statistics are reported as absolute numbers and percentages, mean ± standard deviation (SD) or median ± median absolute deviation.

The study was approved by the local IRB.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients who suffered from RSE or SRSE and received STP as add on therapy.

排除标准

  • 未提供

研究组 & 干预措施

STP in RSE or SRSE

Patients received additional treatment of SE with STP

干预措施: Stiripentol (Drug)

结局指标

主要结局

Number of participants with cessation of SE by STP

时间窗: up to one week

Median dose of STP

时间窗: From date of first admission until the date of first documented improvement of status epilepticus or severe sideeffects or termination due to lack of effect or date of death from any cause, whichever came first, assessed up to 12 months

Cessation of Status epilepticus

时间窗: time to cessation of SE, normally during the first days of admission, up to one week

次要结局

  • Individualised order of the anti-seizure medication administered(From date of first admission until the date of first documented improvement of status epilepticus or severe sideeffects or termination due to lack of effect or date of death from any cause, whichever came first, assessed up to 12 months)
  • Treatment in combination with other anti-seizure medication(From date of first admission until the date of first documented improvement of status epilepticus or severe sideeffects or termination due to lack of effect or date of death from any cause, whichever came first, assessed up to 12 months)

研究者

发起方
University Hospital Marburg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leona Möller

Leona Möller, MD; Principal Investigator, Consultant in Neurology

University Hospital Marburg

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