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Open Access 08-06-2024 | Epilepsy | ORIGINAL RESEARCH

Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study

Authors: Simona Lattanzi, Federica Ranzato, Carlo Di Bonaventura, Paolo Bonanni, Antonio Gambardella, Elena Tartara, Giovanni Assenza, Michela Procaccini, Nathalie Falsetto, Valentina Villano, Gabriele Camattari, Alessandra Ori, Giancarlo Di Gennaro, on behalf of the BLESS Study Group

Published in: Neurology and Therapy

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Abstract

Introduction

Despite new anti-seizure medications (ASMs) being introduced into clinical practice, about one-third of people with epilepsy do not reach seizure control. Cenobamate is a novel tetrazole-derived carbamate compound with a dual mechanism of action. In randomized controlled trials, adjunctive cenobamate reduced the frequency of focal seizures in people with uncontrolled epilepsy. Studies performed in real-world settings are useful to complement this evidence and better characterize the drug profile.

Methods

The Italian BLESS (“Cenobamate in Adults With Focal-Onset Seizures”) study is an observational cohort study aimed to evaluate the effectiveness, tolerability, and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy in the context of real-world clinical practice. The study is ongoing and conducted at 50 centers in Italy. This first interim analysis includes participants enrolled until June 2023 and with 12-week outcome data available.

Results

Forty participants with a median age of 36.5 (interquartile range [IQR] 26.0–47.5) years were included. The median monthly seizure frequency at baseline was 6.0 (IQR 2.5–17.3) seizures and 31 (77.5%) participants had failed four or more ASMs before cenobamate. At 12 weeks from starting cenobamate, the median reduction in monthly seizure frequency was 52.8% (IQR 27.1–80.3%); 22 (55.0%) participants had a ≥ 50% reduction in baseline seizure frequency and six (15.0%) reached seizure freedom. The median number of concomitant ASMs decreased from 3 (IQR 2–3) at baseline to 2 (IQR 2–3) at 12 weeks and the proportion of patients treated with > 2 concomitant ASMs decreased from 52.5% to 40.0%. Seven (17.5%) patients reported a total of 12 adverse events, 11 of which were considered adverse drug reactions to cenobamate.

Conclusion

In adults with uncontrolled focal seizures, the treatment with adjunctive cenobamate was well tolerated and was associated with improved seizure control and a reduction of the burden of concomitant ASMs.

Trial Registration Number

NCT05859854 (ClinicalTrials.gov Identifier).
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Metadata
Title
Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study
Authors
Simona Lattanzi
Federica Ranzato
Carlo Di Bonaventura
Paolo Bonanni
Antonio Gambardella
Elena Tartara
Giovanni Assenza
Michela Procaccini
Nathalie Falsetto
Valentina Villano
Gabriele Camattari
Alessandra Ori
Giancarlo Di Gennaro
on behalf of the BLESS Study Group
Publication date
08-06-2024
Publisher
Springer Healthcare
Published in
Neurology and Therapy
Print ISSN: 2193-8253
Electronic ISSN: 2193-6536
DOI
https://doi.org/10.1007/s40120-024-00634-5