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

Safety and Efficacy of Intravenous Brivaracetam Versus Levetiracetam in the Management of Status Epilepticus in Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07163572

Enrollment

152

Registered

2025-09-09

Start date

2025-01-16

Completion date

2025-08-16

Last updated

2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

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.

Interventions

DRUGIntravenous 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.

DRUGIntravenous 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 16 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adverse Events	40 minutes	Labeled yes if any treatment-related adverse event reported 30 minutes post-infusion.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026