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

NCT07163572 | Completed

• 1 other identifier: Dr-Ikram-Multan
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Status Epilepticus

Outcome Measures

Primary Outcomes (1)

• Cessation of seizures

  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.

  30 minutes

Secondary Outcomes (1)

• Adverse Events

  40 minutes

Study Arms (2)

Brivaracetam group

EXPERIMENTAL

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.

Drug: Intravenous brivaracetam

Levetiracetam group

EXPERIMENTAL

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.

Drug: Intravenous levetiracetam

Interventions

Intravenous brivaracetam 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.

Brivaracetam group

Intravenous levetiracetam 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.

Levetiracetam group

Eligibility Criteria

• Age: 1 Month - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

The Children's Hospital and Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

Location

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ikram Rahman

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

  PRINCIPAL INVESTIGATOR

• Nuzhat Noureen, FCPS

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: January 16, 2025
• Primary Completion: August 16, 2025
• Study Completion: August 16, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)