Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498362
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-04
Brief Title:
The New Place of LEVETIRACETAM in the Management of Status Epilepticus in Children
Sponsor:
University Hospital Strasbourg France
Organization:
University Hospital Strasbourg France
Study Overview
Official Title:
The New Place of LEVETIRACETAM in the Management of Status Epilepticus in Children Multicenter Retrospective Study on 151 Children Over Three Months Old
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEVET
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None