Brivaracetam vs. Oxcarbazepine in childhood self-limited focal epilepsies (BRAVO-SeLFEs): A pilot randomized controlled trial.

PURPOSE To compare the efficacy, safety, and behavioral outcomes of brivaracetam with oxcarbazepine in children with self-limited focal epilepsies (SeLFEs). METHODS This is an open-label pilot randomized controlled trial conducted at a tertiary referral center in India. 50 children aged 2-18 years with SeLFEs were enrolled. They were randomized (1:1) to receive either brivaracetam (intervention) or oxcarbazepine (control) for 6 months. The primary endpoint was seizure freedom at 6 months. The secondary end points included epilepsy severity assessment using the Early Childhood Epilepsy Severity Scale (E-Chess), behavioral evaluation with the Child Behavior Checklist (CBCL), and functional assessment via the Vineland Social Maturity Scale (VSMS). Safety outcomes and feasibility parameters were recorded. RESULTS At 6 months, seizure freedom was similar in the intervention (92 %) and control (86 %) groups with similar median cumulative seizures (16 vs. 22, p = 0.37). Both groups showed within-group reductions in median E-Chess scores [baseline, 5 (IQR 5-7); at 6 months, 3 (IQR 3-3)] but no intergroup differences at 6 months. The group x time interaction was not significant (ß = 0.44, p = 0.26). The median VSMS scores were comparable in both control [95 (IQR 91.5-97) to 96 (IQR 93-97)] and intervention [96 (IQR 93.5-98) to 97 (IQR 95-99.5)] groups. No behavioral abnormalities were noted in any participant (CBCL, T < 60). One child in the oxcarbazepine group developed a skin rash requiring drug withdrawal; no adverse effects were reported in the brivaracetam group. The retention rate was high (96 %) with comparable safety and feasibility. CONCLUSION Brivaracetam and oxcarbazepine achieved similar rates of seizure freedom at 6 months without causing any clinically significant behavioral abnormalities in either group.

• Publication year

  2025

• Venue

  Seizure

• Publication date

  2025-11-01

• Fields of study

  Medicine

• Identifiers
  DOI 10.1016/j.seizure.2025.11.011PMID 41265228
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

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