Cenobamate Effectiveness in Real-world Focal Epilepsy: Clinical Outcomes from a Large Single-center Cohort in the USA
Sai Sanikommu1, Yensea Costas Encarnacion2, Tiffany Eatz3, CARLOS MAURICIO MILLAN4, Andres Kanner5
1Department of Neurosurgery, 2Department of Neurology, University of Miami, Miller School of Medicine, 3Department of Neurology, University of Miami Miller School of Medicine, 4Department of Neurology, Baptist Health, Miami, Florida, 5Department of Neurology, University of Miami, Miller School of Medicine, Department of Neurology
Objective:
To evaluate the clinical effectiveness and safety profile of CBM in adults with treatment-resistant focal epilepsy (TRFE) followed in a level IV Epilepsy Center in the USA.
Background:
Focal epilepsy remains challenging to manage, with many patients continuing to experience disabling seizures despite polytherapy. Cenobamate (CBM), a novel antiseizure medication (ASM) with dual mechanism of action, has demonstrated higher rates of seizure freedom than other ASMs. However, there is a limited real-world data on its effectiveness and tolerability.
Design/Methods:
We conducted a retrospective cohort study at our center on all adult patients with TRFE who were prescribed CBM and had at least one follow-up visit for > 6 months, till February 2025. The data collected included demographic characteristics, baseline and follow-up seizure frequency, dose and length of CBM prescribed, adverse effects, and seizure freedom.
Results:
A total of 204 patients (98 females; median age 38 [29-43]) were included in this study. Mean and median baseline seizure frequency were 15.6 / month; 4 (1.5 - 12), respectively. Target dose of 200mg/day was achieved in 153 (75.4%) patients, and the mean time on CBM was 22.9 months. A significant reduction in seizure frequency was achieved with CBM (p < 0.0001), with a drop of mean and median seizure frequencies of 8.2/month and 1 (0-4), respectively. Seizure freedom, defined as being seizure-free for > 6 months, was achieved in 50 (24.6%) of patients. A responder rate of 64.9% (50% reduction in seizure frequency from baseline) was achieved in 131 patients. Discontinuation of CBM occurred in 54 (26.6%) patients, 10 (4.9%) because of lack of efficacy and 39 (19.2%) because of adverse events.
Conclusions:
In this cohort of patients with TRFE, CBM yielded a robust seizure reduction and higher seizure-free rates than those reported in other ASMs.
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