Lacosamide in Neonatal Status Epilepticus

Phase 3

• Conditions: Epilepsy
• Interventions: Drug: Lacosamide; Drug: Phenobarbital

• Registration Number: NCT05291455
• Lead Sponsor: Sherief Abd-Elsalam

Brief Summary

Lacosamide in neonatal status epilepticus

Detailed Description

The study will assess the efficacy of Lacosamide in neonatal status epilepticus

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-03-01
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Last Update Submitted: 2022-03-18
• Study First Posted: 2022-03-22
• Last Update Posted: 2022-03-22
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• neonates with status epilepticus

Exclusion Criteria

• congenital anomalies or organ dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lacosamide	Lacosamide	Lacosamide will be given.
Phenobarbitone	Phenobarbital	Phenobarbital will be given

Primary Outcome Measures

Name	Time	Method
number of children with cessation or improved duration of status epilepticus	1 year	the number of children with cessation or improved duration of status epilepticus

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Tanta, Kafrelsheikh, Egypt