Safety and Effectiveness of Cenobamate in Pediatric Patients with Epilepsy
Abstract number :
3.385
Submission category :
7. Anti-seizure Medications / 7E. Other
Year :
2025
Submission ID :
34
Source :
www.aesnet.org
Presentation date :
12/8/2025 12:00:00 AM
Published date :
Authors :
Harrison Cheng, Pharmacy intern – CHLA
Margaret Kasbarian, Pharmacy intern – CHLA
Jada Phan, Pharmacy intern – CHLA
Chiang Jenna A, PsyD – CHLA
Jessica Bee, PharmD – CHLA
Jacklyn Bradley, PharmD, BCPPS – CHLA
Troy Zeier, MS – CHLA
Presenting Author: Asri Yuliati, MD – CHLA
Rationale: Cenobamate (XCOPRI®), an antiseizure monocarbamate, was FDA-approved in 2019 for the treatment of focal-onset seizures in adults aged 18 years and older. In adult studies, cenobamate demonstrated a promising median seizure reduction of up to 65% among patients with refractory focal epilepsy. While cenobamate is currently used off-label in children and adolescents, its potential in this population is significant, and ongoing randomized controlled trials expect to establish its safety and efficacy in pediatric patients.
Methods: This retrospective, single-center study aimed to investigate the effectiveness and safety of cenobamate as an adjunctive antiseizure medication (ASM) in pediatric patients at Children’s Hospital Los Angeles (CHLA). Patients under 18 years old receiving cenobamate from January 1, 2023, to December 11, 2024, were included in this study. The primary objective was to assess the effectiveness of cenobamate by examining seizure reduction. Secondary endpoints included adverse drug reactions (ADRs) and the cenobamate median dose. Data is summarized using descriptive statistics, including mean, standard deviation, median, interquartile range,
Results: Of our n=31 patients, 52% experienced a 75-100% reduction in seizure frequency, 16% had a 50-75% reduction, 13% had a 25-50% reduction, and 19% had no reduction cenobamate. This collective data translates to a median seizure reduction rate of 80%. The most common ADR was sedation, followed by aggression and mood changes. The median maintenance dose was 150 mg, with a dose of 137.5 mg/day (5.2 mg/kg/day) in patients < 50 kg. We also found that 29% of patients discontinued cenobamate, with 22.6% discontinuing due to ADRs. Notably, the median number of ASMs before cenobamate initiation was five, which decreased to a more manageable two when used concomitantly with cenobamate, highlighting its potential to simplify treatment regimens.
Conclusions: Overall, our study showed that initiation of cenobamate as adjunctive therapy was effective and safe for pediatric patients with refractory epilepsy, with the goals of reducing seizure frequency and establishing improved seizure control.
Funding: None
Anti-seizure Medications