The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children

Recruiting

• Conditions: Epilepsy in Children

• Registration Number: NCT06498362
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.

The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-16
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-04
• Last Update Submitted: 2024-07-04
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12
• Primary Completion: 2025-05
• Study Completion: 2025-05-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 151

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN	Up to 2 years	The non-inferiority of LEVETIRCETAM in comparison with PHENYTOIN is based on a composite primary endpoint consisting of the total duration of the seizure, the need for another antiepileptic treatment to resolve the seizure or recurrence within 24 hours. following the start of treatment for a new status epilepticus and the total duration of hospitalization.; The need for another antiepileptic drug or recurrence is a binary variable with presence (= yes = 1) or absence (= no = 0).; The total duration of the crisis is expressed in minutes, and corresponds to the interval between the identification of the event and the objectification of its cessation.; The total duration of hospitalization is expressed in days, and corresponds to the duration between the first day of hospitalization (regardless of the location) and the day of discharge (regardless of the department).

Trial Locations

Locations (1)

Service pédiatrie 1 - CHU de Strasbourg - France; 🇫🇷 Strasbourg, France