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Brivaracetam vs. Oxcarbazepine in childhood self-limited focal epilepsies (BRAVO-SeLFEs): A pilot randomized
Fathima Fasin1, Ankit Kumar Meena1, Saurabh Agarwal1
1Department of Pediatrics, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India.
Insights
Brivaracetam and oxcarbazepine showed similar seizure freedom rates in children with self-limited focal epilepsies (SeLFEs). Both treatments were safe and did not cause significant behavioral issues, demonstrating comparable efficacy.
Area of Science:
- Pediatric Neurology
- Epileptology
- Clinical Pharmacology
Background:
- Self-limited focal epilepsies (SeLFEs) are common in children.
- Effective and safe treatment options are crucial for managing pediatric epilepsy.
- Comparing novel antiepileptic drugs with established ones is essential for clinical practice.
Purpose of the Study:
- To compare the efficacy, safety, and behavioral outcomes of brivaracetam versus oxcarbazepine in children diagnosed with SeLFEs.
- To evaluate seizure control, epilepsy severity, behavioral, and functional status.
- To assess the feasibility and safety profile of both antiepileptic drugs.
Main Methods:
- An open-label pilot randomized controlled trial involving 50 children (aged 2-18 years) with SeLFEs.
- Participants were randomized to receive either brivaracetam or oxcarbazepine for 6 months.
- Primary endpoint was seizure freedom; secondary endpoints included epilepsy severity (E-Chess), behavior (CBCL), and social maturity (VSMS).
Main Results:
- Seizure freedom rates were comparable at 6 months (92% for brivaracetam vs. 86% for oxcarbazepine).
- Both groups showed reduced epilepsy severity scores with no significant intergroup differences.
- No clinically significant behavioral abnormalities were observed; brivaracetam had a superior safety profile with no adverse events reported.
Conclusions:
- Brivaracetam and oxcarbazepine are similarly effective in achieving seizure freedom in children with SeLFEs.
- Both medications are well-tolerated and do not appear to cause significant behavioral issues.
- Brivaracetam presents a favorable safety profile, making it a viable treatment option for pediatric epilepsy.
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.
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