Evaluating LEVETIRACETAM for treating status epilepticus in children
The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children: Multicenter Retrospective Study on 151 Children Over Three Months Old
This study tests if the medication LEVETIRACETAM is just as good as PHENYTOIN for stopping long-lasting seizures in children aged 3 months to 17 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 151 (estimated) |
| Ages | 3 Months to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT06498362 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of LEVETIRACETAM compared to PHENYTOIN in managing status epilepticus in children aged 3 months to 17 years. The research aims to determine if LEVETIRACETAM is non-inferior to PHENYTOIN in stopping seizures and preventing recurrence, while also assessing the clinical tolerance of the medication. The study includes patients who have experienced a seizure lasting more than 5 minutes and have not responded to benzodiazepines. Data will be collected from participating centers in Strasbourg, France, from November 2019 to May 2023.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 17 years who require second-line treatment for status epilepticus after benzodiazepine failure.
Not a fit: Patients or parents who oppose the reuse of their data for research purposes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective treatment option for children experiencing status epilepticus.
How similar studies have performed: While the approach of comparing LEVETIRACETAM to PHENYTOIN is not widely tested, existing studies suggest potential benefits of LEVETIRACETAM in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Minor patient aged 3 months to 17 years * 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines * Supported in one of the participating centers during the period from November 1, 2019 to May 31, 2023 * Subject or parents who have not expressed, after information, their opposition to the reuse of their data for the purposes of this research. Exclusion Criteria: * Patient or parents having expressed their opposition to participating in the study.
Where this trial is running
Strasbourg
- Service pédiatrie 1 - CHU de Strasbourg - France — Strasbourg, France (Recruiting)
Study contacts
- Study coordinator: Sarah BAER, MD
- Email: sarah.baer@chru-strasbourg.fr
- Phone: 33 3 88 12 63 98
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.