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OpenTrials
Completed

NCT Number: NCT07163585

Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

1 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Children's Hospital and Institute of Child Health

Multan, Punjab Province, 66000, Pakistan

About this study

Most existing studies have focused on adjunctive use or refractory epilepsy, while evidence in treatment-naïve pediatric populations remains sparse. Addressing this gap is critical, as early and effective seizure control can substantially influence long-term neurodevelopmental outcomes. By evaluating seizure outcomes, tolerability, and adverse effect profiles, this study aims to provide evidence to guide clinicians in selecting the most appropriate first-line anti-seizure medication (ASM) for pediatric patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children of either gender
  • Aged 1 month to 14 years
  • With a clinical diagnosis of newly diagnosed epilepsy

Exclusion criteria

  • History of prior use of long-term antiseizure medications
  • Evidence of progressive neurological disease
  • Metabolic abnormalities
  • Structural brain malformations
  • Incompatible with monotherapy
  • Severe systemic comorbidities

Treatment and study plan

Brivaracetam

Drug

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.

Levetiracetam

Drug

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.

Primary outcomes

  1. Cessation of seizures

    Time frame: Up to 3 months

    Cessation of seizures was labeled "yes" when a patient remained seizure free.

Secondary outcomes

  1. Adverse events

    Time frame: Up to 3 months

    Labeled "yes" if any treatment-related adverse events reported.

Sponsors and collaborators

Lead sponsor

RESnTEC, Institute of Research

Other

Registry information

Official study title

Safety and Efficacy of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Children Aged 1 Month to 14 Years With Newly Diagnosed Epilepsy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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