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NCT Number: NCT06498362

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

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

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Key information

Conditions

Epilepsy in Children Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Armelle HORNARD, MD

SUB_INVESTIGATOR

Sarah BAER, MD

CONTACT

[email protected]

33 3 88 12 63 98

Sarah BAER, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah BAER, MD

CONTACT

[email protected]

33 3 88 12 63 98

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: LEVET

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Jul 12, 2024
Registry last updated: Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting