Real‐world effectiveness and tolerability of cenobamate in drug‐resistant epilepsy: A retrospective analysis of the patients included into the Early Access Programs (<scp>EAP</scp>) in Germany, France, and <scp>United Kingdom</scp>

This study involved patients with drug-resistant epilepsy, who had continued seizures despite using at least two antiseizure medications (ASMs). Patients received cenobamate (Ontozry) as epilepsy treatment during the Early Access Program (EAP) in France, Germany, and the United Kingdom. An EAP allows patients to receive promising new drugs under clinical supervision before they are commercially available. After 6 months from cenobamate start, 49.3% of patients had their seizures cut by half or more, and 13.6% became seizure-free. A total of 30.9% of patients had an undesirable reaction to cenobamate, mostly mild-to-moderate and resolved; the most frequent were asthenia, dizziness, and somnolence.

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Publication Details

Journal
Epilepsia Open
Published
2025-03-22
DOI
https://doi.org/10.1002/epi4.70021
Citations
4
Primary Topic
Epilepsy research and treatment
Type
article
Field-Weighted Citation Impact
5.88

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article

Real‐world effectiveness and tolerability of cenobamate in drug‐resistant epilepsy: A retrospective analysis of the patients included into the Early Access Programs (EAP) in Germany, France, and United Kingdom

Caroline Benoist, Sylvain Rheims, Bernhard J. Steinhoff, Felix Rosenow et al.
4 citations
Epilepsia Open
Epilepsy research and treatment
5.88
article

Real‐world effectiveness and tolerability of cenobamate in drug‐resistant epilepsy: A retrospective analysis of the patients included into the Early Access Programs (EAP) in Germany, France, and United Kingdom

Caroline Benoist, Sylvain Rheims, Bernhard J. Steinhoff, Felix Rosenow, John Paul Leach, Rhys Huw Thomas, Agnese Cattaneo, Paola Lipone, E. Baron, Alessandro Comandini, Édouard Hirsch, Arnaud Biraben, Karthinathan Thangavelu, Alessandro Lovera
article en
4 citations

Abstract

This study involved patients with drug-resistant epilepsy, who had continued seizures despite using at least two antiseizure medications (ASMs). Patients received cenobamate (Ontozry) as epilepsy treatment during the Early Access Program (EAP) in France, Germany, and the United Kingdom. An EAP allows patients to receive promising new drugs under clinical supervision before they are commercially available. After 6 months from cenobamate start, 49.3% of patients had their seizures cut by half or more, and 13.6% became seizure-free. A total of 30.9% of patients had an undesirable reaction to cenobamate, mostly mild-to-moderate and resolved; the most frequent were asthenia, dizziness, and somnolence.

Epilepsia OpenVol. 10(3)
Université Claude Bernard Lyon 1 (FR), Goethe University Frankfurt (DE), Centre National de la Recherche Scientifique (FR), Inserm (FR), University of Freiburg (DE), Royal Victoria Infirmary (GB), University Medical Center Freiburg (DE), Centre de Recherche en Neurosciences de Lyon (FR), Hospices Civils de Lyon (FR), Hôpital Pontchaillou (FR), University Hospital Frankfurt (DE), Diakonie Kork (DE), Angelini Pharma (Italy) (IT), Université de Strasbourg (FR), Newcastle University (GB)
Angelini Pharma
Good health and well-being
Openalex Percentile: Top 4%
Epilepsy research and treatment
5.88
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