Evidence map›Paper›PMID 39954117›Full record

ArticleCNS drugs2025

Post-marketing Experience with Cenobamate in the Treatment of Focal Epilepsies: A Multicentre Cohort Study.

Adam Strzelczyk, Felix von Podewils, Hajo M Hamer, Susanne Knake, Felix Rosenow, Kerstin Alexandra Klotz, Gerhard Kurlemann, Nico Melzer, Elisa Buhleier, Catrin Mann and 9 more

Abstract readMulticenter Study
In one paragraph

Article in CNS drugs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed.

  1. Review
  2. Article
  3. Observational
  4. GABACellular and molecular neurobiology · 2026
    Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Adam StrzelczykEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany. strzelczyk@med.uni-frankfurt.de.ORCID 0000-0001-6288-9915
Felix von PodewilsDepartment of Neurology, Epilepsy Center, University Hospital Greifswald, Greifswald, Germany.
Hajo M HamerDepartment of Neurology, Epilepsy Center, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
Susanne KnakeDepartment of Neurology, Epilepsy Center Hessen, Philipps-University Marburg, Marburg (Lahn), Germany.
Felix RosenowEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Kerstin Alexandra KlotzDepartment of Pediatric Neurology, University Hospital Bonn, Bonn, Germany.
Gerhard KurlemannSt. Bonifatius Hospital, Lingen, Germany.
Nico MelzerDepartment of Neurology, Medical Faculty and University Hospital, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Elisa BuhleierEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Catrin MannEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Laurent M WillemsEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Johann Philipp ZöllnerEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.
Bernadette GaidaDepartment of Neurology, Epilepsy Center, University Hospital Greifswald, Greifswald, Germany.
Jeanne CunyDepartment of Neurology, Epilepsy Center, University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany.
David BellaireDepartment of Neurology, Epilepsy Center Hessen, Philipps-University Marburg, Marburg (Lahn), Germany.
Ilka ImmischDepartment of Neurology, Epilepsy Center Hessen, Philipps-University Marburg, Marburg (Lahn), Germany.
Leena KämppiDepartment of Neurology, Epilepsia Helsinki, European Reference Network EpiCARE, Helsinki University Hospital and University of Helsinki, Helsinki, Finland.
Andreas BrunklausSchool of Health and Wellbeing, University of Glasgow, Glasgow, UK.
Susanne Schubert-BastEpilepsy Center Frankfurt Rhine-Main, Department of Neurology, Goethe-University Frankfurt, University Medicine Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn randomised controlled trials, adjunctive cenobamate (CNB) has been shown to reduce seizure frequency in patients with drug-resistant focal epilepsy. Studies conducted in real-world settings provide valuable complementary data to further characterise the drug's profile.

objectiveTo assess the efficacy, retention and tolerability of adjunctive cenobamate (CNB), and to identify factors that might predict these outcomes in the clinical treatment of focal epilepsies.

methodsThis multicentre, retrospective cohort study included all patients who began CNB treatment between October 2020 and April 2023 at seven participating epilepsy centres. Baseline and follow-up data were collected from patients' medical records, covering clinical characteristics and outcome data such as seizure frequency, dosing of CNB, physician-assessed Clinical Global Impression of Change, treatment-emergent adverse events (TEAEs), CNB retention and reasons for discontinuation.

resultsA total of 234 patients [mean age 40.7 ± 14 years, median 40 years, range 11-82 years; five adolescents under 18 years; 99 (42.3%) males] were analysed. The mean epilepsy duration at study entry was 23.2 ± 14.5 years (median 21 years, range 0.75-63 years), with the average age of epilepsy onset being 17.5 ± 13.0 years (median 17 years, range 0.1-71 years). The patients were taking a mean of 2.6 ± 0.8 (median 3) anti-seizure medications (ASMs) before starting CNB, and had failed a mean of 6 ± 3.3 (median 6) of further ASMs in the past. CNB exposure ranged from 5 to 1162 days, amounting to a total exposure time of 264.7 years. The retention rate was 92.6% at 3 months, 87.2% at 6 months and 77.8% at 12 months. At 3 months, 52.6% achieved a 50% seizure reduction, with 14.5% reporting seizure freedom; by 12 months, 47.7% maintained a 50% response rate and 11.9% were seizure-free. No significant differences in responder rates were observed based on sex, aetiology, seizure localisation, number of ASMs or target dose. The mean maximum CNB dose was 236.7 ± 97.4 mg (median 200 mg, range 12.5-450 mg), with 28 patients (12.0%) titrated up to 400 mg or above. During CNB treatment, 43.6% of patients were able to discontinue, and a further 24.4% were able to reduce the dose of a concomitant ASM. During CNB treatment, 144 patients (61.5%) experienced TEAEs. The most common TEAEs were sedation (n = 84, 35.9%), dizziness (n = 58, 24.8%) and ataxia (n = 23, 9.8%).

conclusionsCNB showed a relatively high and clinically useful 50% responder rate of 47.7% and an overall retention of 77.8% at 1 year. We were unable to identify specific predictors for response and retention, indicating that CNB may be beneficial for patients with a history of multiple failed ASMs, a high number of concomitant ASMs and any localisation or aetiology of focal epilepsy.

Indexed as

AnticonvulsantsCarbamatesChlorophenolsEpilepsies, PartialAdolescentAdultAgedAged, 80 and overChildCohort StudiesFemaleHumansMaleMiddle AgedProduct Surveillance, PostmarketingRetrospective StudiesAnticonvulsantsCarbamatesCenobamateChlorophenolsTetrazoles

Identifiers

PMID39954117
PMCPMC11850496

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.