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. 2025 May;15(5):e70567.
doi: 10.1002/brb3.70567.

Cenobamate in Real-Word Scenario: Results on Efficacy, Side Effects, and Retention Rate in a Single Center Retrospective Study

Mostafa Badr  1 , Christoph Helmstaedter  1 , Susanna Moskau-Hartmann  1 , Jan Pukropski  1 , Juri-Alexander Witt  1 , Theodor Rüber  1 , Karmele Olaciregui Dague  1 , Tobias Baumgartner  1 , Michael Rademacher  1 , Rainer Surges  1 , Randi von Wrede  1
Affiliations

Cenobamate in Real-Word Scenario: Results on Efficacy, Side Effects, and Retention Rate in a Single Center Retrospective Study

Mostafa Badr et al. Brain Behav. 2025 May.

Abstract

Background: Pharmacoresistance imposes a high burden on people with epilepsy (PWE). Recently authorized cenobamate (CNB) offers new hope with high efficacy reported in phase III and early real-world studies. Here, we present data from a reasonably sized monocentric cohort, complementing the knowledge derived from clinical practice.

Methods: We retrospectively analyzed medical records of all PWE treated with CNB from market entry to July 31, 2023.

Results: After an average of 1.1 years, follow-up data were available for 262 out of 280 PWE, who received at least one dose of CNB. The average CNB dose was 183 ± 98 mg/d, with a mean number of anti-seizure medications (ASM) of 2.9 ± 1 per patient. A total of 36% of the patients showed ≥ 50% reduction in seizure frequency (10.7% were seizure-free), whilst 12.3% reported increased seizure frequency. Seizure freedom was associated with concomitant perampanel or GABA receptor modulators. No predictors of treatment response were found. Side effects were reported by 38%, alertness issues being most prevalent (19%). The retention rate amounted to 72% and was associated with response status, dose of CNB, side effects, and age at CNB introduction. Among those who discontinued CNB, 55% experienced side effects and 89% showed no meaningful seizure reduction. Regarding co-medication, the withdrawal of lamotrigine, brivaracetam, clobazam, or lacosamide was associated with higher rates of non-response.

Conclusions: In this large cohort of 262 PWE, CNB proved very efficient with a high retention rate over one year. Co-medication with perampanel or GABA receptor modulators was linked to seizure-freedom. The overall positive impression of CNB is further supported.

Keywords: cenobamate; efficacy; real‐world data; retention rate; side effects.

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Figures

FIGURE 1
FIGURE 1
Efficacy and retention of CNB.
FIGURE 2
FIGURE 2
Side effects of CNB.
FIGURE 3
FIGURE 3
Percentage of withdrawal of concomitant ASMs and its effect.
See this image and copyright information in PMC

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