Clinical trial NCT06540378: Stiripentol for the Treatment of Refractory Status Epilepticus
Official title: Stiripentol for the Treatment of Refractory Status Epilepticus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Status Epilepticus
Keywords: Status epilepticus
Epilepsy
Stiripentol
Lead sponsor: University Hospital Marburg
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Treatment success was defined as continuous interruption of the SE.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* children

Primary outcomes:
measure: Cessation of Status epilepticus
timeFrame: time to cessation of SE, normally during the first days of admission, up to one week
measure: Number of participants with cessation of SE by STP
timeFrame: up to one week
measure: Median dose of STP
timeFrame: 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
Secondary outcomes:
measure: Treatment in combination with other anti-seizure medication
timeFrame: 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
measure: Individualised order of the anti-seizure medication administered
timeFrame: 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
Other outcomes:
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