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

NCT ID: NCT06498362

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-16

Study Completion Date

2025-05-16

Brief Summary

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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

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Conditions

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Epilepsy in Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sarah BAER, MD

Role: CONTACT

33 3 88 12 63 98

Facility Contacts

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Sarah BAER, MD

Role: primary

33 3 88 12 63 98

Other Identifiers

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9067

Identifier Type: -

Identifier Source: org_study_id

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