Status EpilepticusNCT06540378
Stiripentol for the Treatment of Refractory Status Epilepticus
An observational study of Status Epilepticus, run by University Hospital Marburg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus
- What is being tested?
- Stiripentol
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult patients who suffered from RSE or SRSE and received STP as add on therapy.
Who cannot join
- children
About this study
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.
Read the 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.
- Conditions
- Status Epilepticus
- Being tested
- Stiripentol
- Keywords
- Status epilepticus, Epilepsy, Stiripentol
- Medical subject headings
- Status Epilepticus, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StiripentolDrug
Also called Diacomit
| Study group | Role | What they receive |
|---|---|---|
| STP in RSE or SRSE | Patients received additional treatment of SE with STP Receives: Drug: Stiripentol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cessation of Status epilepticus
Measured: 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
Measured: up to one week
Median dose of STP
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Jan 2013
- Primary completion31 Dec 2023
- Study completionMay 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leona Möller, University Hospital Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06540378
- Sponsor's protocol ID
- 24-61 RS
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39428490
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stiripentol for the Treatment of Refractory Status Epilepticus
- ClinicalTrials.gov ID
- NCT06540378
- Acronym / sponsor ID
- 24-61 RS
- Conditions
- Status Epilepticus
- Keywords
- Status epilepticus, Epilepsy, Stiripentol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital MarburgUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- May 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STP in RSE or SRSE | – | Drug: StiripentolPatients received additional treatment of SE with STP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adult patients who suffered from RSE or SRSE and received STP as add on therapy.
Key exclusion criteria (1 listed)
- children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| StiripentolAlso: Diacomit | Drug | STP in RSE or SRSE |
Primary outcome
Cessation of Status epilepticus
Time frame: 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
Time frame: up to one week
Median dose of STP
Time frame: 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
2 secondary outcomes
Treatment in combination with other anti-seizure medication
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 39428490Moller 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.
- Individual participant dataSharing planned: No
Related trials for Status Epilepticus
RecruitingPhase 3
A Study to Test the Efficacy and Safety of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Not yet recruitingObservational study
Predictors of Outcomes of Convulsive Status Epilepticus
Status Epilepticus, Convulsive Status Epilepticus
Enrolling by invitationPhase 3
A Study to Test the Safety and Tolerability of Staccato Alprazolam in Study Participants 12 Years of Age and Older With Stereotypical Prolonged Seizures
Stereotypical Prolonged Seizures
Recruiting
Acute Effects of Focused Ultrasound Modulation on EEG Behavior in Status Epilepticus Patients
Seizures
RecruitingPhase 3
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Status Epilepticus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus, run by University Hospital Marburg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cessation of Status epilepticus (time frame: time to cessation of SE, normally during the first days of admission, up to one week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06540378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.