NCT07163585

Comparison of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Epilepsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: RESnTEC, Institute of Research · Academic / Other
• Sex: All
• Age: 1 Month – 14 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Epilepsy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2025-09-09
• Last updated: 2025-09-09

Locations

1 site across 1 country: Pakistan