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

NCT06498362 | Recruiting

• 1 other identifier: 9067
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy in Children

Keywords

Epilepsy; Epilepsy in Children

Outcome Measures

Primary Outcomes (1)

• Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN

  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).

  Up to 2 years

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Minor patient aged 3 months to 17 years having 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines

You may qualify if:

• Minor patient aged 3 months to 17 years
• nd 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.

You may not qualify if:

• Patient or parents having expressed their opposition to participating in the study.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sarah BAER, MD

CONTACT

33 3 88 12 63 98; sarah.baer@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 12, 2024
• Study Start: November 16, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 16, 2025
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (1)