Real-world use of cenobamate in pediatric focal epilepsies and developmental epileptic encephalopathies: A multicenter retrospective series.

Authors

Víctor Soto-Insuga, Adrián Valls Carbó, Anna Gretel Pinzón-Acevedo, Elena González-Alguacil, Juan José García Peñas, Andrea Sariego Jamardo, Gemma Aznar-Laín, Salvador Ibáñez-Micó, Helena Alarcón Martínez, Raquel Buenache, Saray Rekarte, Andrea Parejo Olivera, Ezequiel Tuero-Montiel, Jana DomínguezCarral, María López, Ainhoa García Ribes, María Jesús Martínez González, Eva Arias, Adrián García Ron, Susana Boronat, Eulalia Turón Viñas, Dolors Casellas, Virginia Navarro, David Conejo, Elena Miravet, Irene Sánchez-Miranda Román, Antonio Gil Nagel-Rein, María Muñoz Cabeza, Patricia Smeyers, Ángel Aledo-Serrano

Published in

Epilepsia. Jul 30, 2025. Epub Jul 30, 2025.

Abstract

Cenobamate (CNB) is an anti-seizure medication approved for focal-onset seizures in adults, with growing evidence supporting its use in pediatric drug-resistant epilepsy (DRE). This study evaluates the efficacy, retention, and safety of CNB in children and adolescents, including those with developmental and epileptic encephalopathies (DEEs).
We conducted a retrospective, multicenter study of 169 pediatric patients (0-18 years) with DRE treated with CNB across centers in Spain. Seizure response (≥50% reduction) and seizure freedom (no seizures in the previous month) were assessed at 3, 6, and 12 months.
At 12 months, CNB showed a retention rate of 89.2%, with 83.9% of patients achieving seizure response and 19.6% reaching seizure freedom. Response rates were 73.4% at 3 months and 77.1% at 6 months, with seizure freedom increasing from 11.8% at 3 months to 21.1% at 6 months. Outcomes were comparable between DEEs and focal epilepsies, indicating broad-spectrum efficacy. Seizure worsening occurred in 4.7% of patients, all with DEEs. After adjusting for seizure type, those patients with focal seizures had higher odds of achieving seizure response (odds ratio [OR] 95% confidence interval [95% CI] 5.46, 1.27-23.52; p = 0.02) and seizure freedom (OR 95% CI 5.32, 1.57-17.97; p < 0.01). Median CNB doses (mg/kg/day) were 1.78 (range 0.37-12.5), 2.5 (range 0.67-12.5), and 3.19 (range 0.96-9.09) at 3, 6, and 12 months, respectively. Adverse events occurred in 44.9% of patients, most commonly somnolence (42.3%) and dizziness (22.4%), which improved with slower titration.
CNB appears effective and well-tolerated in pediatric DRE, including DEE, with high retention and sustained efficacy over time. Adverse events were generally manageable with dose adjustments, and slow, weight-based titration improved tolerability. Prospective studies are warranted to confirm these findings.

PMID:
40736694
Bibliographic data and abstract were imported from PubMed on 30 Jul 2025.

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