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Safety and Efficacy of Oral Brivaracetam Versus Levetiracetam as Monotherapy in Children Aged 1 Month to 14 Years With Newly Diagnosed 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.
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.
Age
0 - 14 years
Sex
ALL
Healthy Volunteers
No
The Children's Hospital and Institute of Child Health
Multan, Punjab Province, Pakistan
Start Date
August 1, 2024
Primary Completion Date
July 31, 2025
Completion Date
July 31, 2025
Last Updated
September 9, 2025
102
ACTUAL participants
Brivaracetam
DRUG
Levetiracetam
DRUG
Lead Sponsor
RESnTEC, Institute of Research
NCT06700356
NCT02531880
NCT05871372
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