Stiripentol for the Treatment of Refractory Status Epilepticus

NCT06540378 | Completed

• 1 other identifier: 24-61 RS
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Status Epilepticus

Keywords

Status epilepticus; Epilepsy; Stiripentol

Outcome Measures

Primary Outcomes (3)

• Cessation of Status epilepticus

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

• Number of participants with cessation of SE by STP

  up to one week

• Median dose of STP

  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 (2)

• 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

• 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

Study Arms (1)

STP in RSE or SRSE

Patients received additional treatment of SE with STP

Drug: Stiripentol

Interventions

Stiripentol DRUG

Also known as: Diacomit

STP in RSE or SRSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• children

Sponsors & Collaborators

• University Hospital Marburg: lead

Related Publications (1)

• Moller L, Simon OJ, Junemann C, Austermann-Menche M, Bergmann MP, Habermehl L, Menzler K, Timmermann L, Strzelczyk A, Knake S. Stiripentol for the treatment of refractory status epilepticus. Neurol Res Pract. 2024 Oct 21;6(1):49. doi: 10.1186/s42466-024-00348-x.

  PMID: 39428490 DERIVED

MeSH Terms

Conditions

Status Epilepticus; Epilepsy

Interventions

stiripentol

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leona Möller, MD; Principal Investigator, Consultant in Neurology

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 6, 2024
• Study Start: January 1, 2013
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2024
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share