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

NCT ID: NCT07163572

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-16
• Study Completion Date: 2025-08-16

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.

Conditions

Status Epilepticus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brivaracetam group

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.

Group Type: EXPERIMENTAL

Intravenous brivaracetam

Intervention Type: DRUG

Patients received intravenous 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

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.

Group Type: EXPERIMENTAL

Intravenous levetiracetam

Intervention Type: DRUG

Patients received intravenous levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes.

Interventions

Intravenous brivaracetam

Patients received intravenous brivaracetam as a loading dose of 2 mg/kg (maximum 100 mg) diluted in 100 ml of normal saline infused over 10 minutes.

Intervention Type: DRUG

Intravenous levetiracetam

Patients received intravenous levetiracetam as a loading dose of 40 mg/kg (maximum 3000 mg) diluted in 100 ml of normal saline infused over 10 minutes.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Muhammad Aamir Latif

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Aamir Latif

Research Consultant

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ikram Rahman

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital and institute of Child Health, Multan, Pakistan

Nuzhat Noureen, FCPS

Role: STUDY_DIRECTOR

Children's Hospital and institute of Child Health, Multan, Pakistan

Locations

The Children's Hospital and Institute of Child Health

Multan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Dr-Ikram-Multan

Identifier Type: -

Identifier Source: org_study_id