Comparison of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus

Not Applicable

Completed

• Conditions: Status Epilepticus
• Interventions: Drug: Intravenous brivaracetam; Drug: Intravenous levetiracetam

• Registration Number: NCT07163572
• Lead Sponsor: Muhammad Aamir Latif

Brief Summary

Brivaracetam is increasingly being studied in adult status epilepticus populations, evidence in pediatric patients remains sparse, with only limited case series and observational studies reporting favorable outcomes. This study aims at direct comparison between intravenous brivaracetam and levetiracetam in the acute management of pediatric status epilepticus.

Detailed Description

Given the urgent need for safe and effective alternatives in pediatric status epilepticus and the limited head-to-head data comparing intravenous brivaracetam with levetiracetam, especially in children, this study has been designed to evaluate their relative safety and efficacy. The research seeks to generate evidence that may help guide clinical decision-making and optimize outcomes in this vulnerable population.

Study Timeline

• Study Start: 2025-01-16
• Status Verified: 2025-08
• Primary Completion: 2025-08-16
• Study Completion: 2025-08-16
• Study First Submitted: 2025-09-01
• Study First Submitted QC: 2025-09-01
• Last Update Submitted: 2025-09-01
• Study First Posted: 2025-09-09
• Last Update Posted: 2025-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• Either gender
• Aged one month to 16 years
• Presenting with status epilepticus

Exclusion Criteria

• Previously received intravenous antiseizure medication for the current episode prior to presentation
• Known hypersensitivity to study drugs
• Hemodynamically unstable, requiring inotropic support before administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brivaracetam group	Intravenous brivaracetam	Patients received brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes.
Levetiracetam group	Intravenous levetiracetam	Patients received levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes.

Primary Outcome Measures

Name	Time	Method
Cessation of seizures	30 minutes	Cessation of seizures was labeled "yes" if cessation of clinical seizures occurred within 20-30 minutes of infusion without the need for additional antiseizure medication.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	40 minutes	Labeled "yes" if any treatment-related adverse event reported 30 minutes post-infusion.

Trial Locations

Locations (1)

The Children's Hospital and Institute of Child Health; 🇵🇰 Multan, Punjab Province, Pakistan