Seizure · 2025
Brivaracetam vs. Oxcarbazepine in childhood self-limited focal epilepsies (BRAVO-SeLFEs): A pilot randomized controlled trial.
СтатьяРандомизированное исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Fasin Fathima, Meena Ankit Kumar, Agarwal Saurabh, Saini Lokesh, Manjunathan Sujatha, Gupta Tanu, Gupta Rahul, Chityala Ashwini, Goyal Jagdish Prasad, Nebhinani Naresh, Singh Kuldeep
Аннотация
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.
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.