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Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

NCT07163585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2025-09-09

No results posted yet for this study

Summary

Despite increasing clinical use of both agents, there is a paucity of head-to-head comparative data on the safety and efficacy of brivaracetam versus levetiracetam as initial monotherapy in children. The present study was therefore designed to compare the safety and efficacy of oral brivaracetam and levetiracetam as monotherapy in children aged one month to 14 years with newly diagnosed epilepsy.

Conditions

Interventions

DRUG

Brivaracetam

Brivaracetam was initiated at a dose of 1-2 mg/kg/day in two divided doses, titrated to a maximum of 5 mg/kg/day based on clinical response and tolerability.

DRUG

Levetiracetam

Levetiracetam was initiated at a dose of 10-20 mg/kg/day in two divided doses, with gradual escalation up to 60 mg/kg/day if needed.

Sponsors & Collaborators

  • RESnTEC, Institute of Research

    lead OTHER

Principal Investigators

  • Ikram Rahman · Children's Hospital and institute of Child Health Multan, Pakistan

  • Nuzhat Rahman, FCPS · Children's Hospital and institute of Child Health Multan, Pakistan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Pakistan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07163585 on ClinicalTrials.gov