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

July 4, 2024 updated by: University Hospital, Strasbourg, France

The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children: Multicenter Retrospective Study on 151 Children Over Three Months Old

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

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service pédiatrie 1 - CHU de Strasbourg - France
        • Contact:
        • Principal Investigator:
          • Sarah Baer, MD
        • Sub-Investigator:
          • Armelle HORNARD, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN
Time Frame: 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).
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 16, 2023

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 16, 2025

Study Registration Dates

First Submitted

July 4, 2024

First Submitted That Met QC Criteria

July 4, 2024

First Posted (Actual)

July 12, 2024

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 4, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9067

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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