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

Muhammad Aamir Latif

Status: Completed

Conditions: Status Epilepticus

Treatments: Drug: Intravenous brivaracetam; Drug: Intravenous levetiracetam

Study type: Interventional

Funder types: Other

Identifiers

NCT07163572

Dr-Ikram-Multan

Details and patient eligibility

About

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.

Full 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.

Enrollment: 152 patients

Sex: All

Ages: 1 month to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 2 patient groups

Brivaracetam group

Experimental group

Description:

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.

Treatment:

Drug: Intravenous brivaracetam

Levetiracetam group

Experimental group

Description:

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.

Treatment:

Drug: Intravenous levetiracetam