Abstract
Aim and objectives Focal seizures impact a significant portion of the pediatric population. The efficacy and safety of current antiseizure medications (ASMs) remain subjects of ongoing debate, prompting the evaluation of newer, safer drugs. Brivaracetam (BRV), a novel ASM, has yet to be fully compared to established first-line ASMs, particularly in pediatric patients. Thus, this study was planned to compare the efficacy, safety, and tolerability of oxcarbazepine (OXC) and BRV in children with focal epilepsy. Materials and methods Pediatric patients with focal seizures, aged four to 14 years, were prospectively enrolled in this comparative study after informed parental consent. Patients with seizures due to metabolic abnormalities or concomitant chronic systemic illnesses were excluded. A complete history-taking, physical examination, anthropometry, and relevant investigations (including electroencephalogram and neuroimaging) were done in all cases. Participants were randomized to receive either OXC or BRV and followed for up to six months. Participants were followed monthly for compliance, anthropometric measurements, seizure recurrence, and any clinical adverse effects. Seizure-free outcome at six months was the primary outcome. Treatment-emergent adverse events (TEAEs) were recorded and analyzed statistically as secondary outcomes. Results Of the 327 participants, 292 completed the study (OXC: 144; BRV: 148). Seizure-free outcome rates at three and six months were 83.3% (120/144) and 65.3% (94/144) in the OXC group, and 77.7% (115/148) and 73.0% (108/148) in the BRV group, respectively, with no statistically significant difference between the groups. Both medications were well tolerated. Somnolence, behavioral abnormalities, and headache were the most common adverse effects. However, the OXC group had a significantly higher incidence of hyponatremia and weight gain compared to the BRV group. Conclusion No significant difference in seizure-free outcome rates or overall adverse effects between the groups was seen, indicating that BRV is comparable to OXC in treating pediatric focal epilepsy and can be used in cases where OXC is non-tolerated or has adverse effects.