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

Abstract

Background: Epilepsy is one of the most common chronic neurological disorders in childhood.

Objective: To compare the safety and efficacy of oral brivaracetam, and levetiracetam as monotherapy in children with newly diagnosed epilepsy.

Methods: This randomized controlled trial was conducted at the Pediatric Neurology Department, Children Hospital Multan, Pakistan, during August 2024–February 2025. A total of 102 children aged 1 month to 14 years with newly diagnosed epilepsy, were randomized to receive oral brivaracetam or levetiracetam monotherapy. Seizure freedom at 3-month, seizure frequency reduction, time to 1^st breakthrough seizure, and adverse effects were documented. Data analysis was performed using IBM-SPSS Statistics, version 26.0, taking p<0.05 as significant.

Results: Among 102 enrolled children, the median age was 6.3 (IQR 3.5-10.2) years, while 55 (55.9%) were males. At 3-month, 97 (95.1%) children completed follow-up, while seizure freedom was achieved in 39 (79.6%) brivaracetam-treated, and 35 (72.9%) levetiracetam-treated children (p=0.332). The median reduction in monthly seizure days was 4.5 (IQR 3.2–6.0) with brivaracetam, and 4.2 (IQR 3.0–6.0) with levetiracetam (p=0.474). The median time to 1^st breakthrough seizure was 35.6 (IQR 20.2–60.4) days with brivaracetam, and 30.3 (IQR 18.0–55.5) days with levetiracetam (p=0.563). Adverse events occurred in 44 (45.4%) children, mainly somnolence (11.3%) and irritability (10.3%), without any significant differences (p>0.05)

Conclusion: Brivaracetam, and levetiracetam demonstrated comparable efficacy in achieving seizure freedom and reducing seizure frequency in children with newly diagnosed epilepsy.