Evidence map›Paper›PMID 38954033›Full record

Observational studyJournal of neurology2024

Cenobamate: real-world data from a retrospective multicenter study.

Stephan Lauxmann, David Heuer, Jan Heckelmann, Florian P Fischer, Melanie Schreiber, Elisabeth Schriewer, Guido Widman, Yvonne Weber, Holger Lerche, Michael Alber and 2 more

Erratum issuedAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Article
  4. Observational
  5. Cenobamate: An Appraisal Five Years On.Neurology and therapy · 2026
    Review
  6. Review
  7. Observational
  8. Article
  9. Observational
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Stephan LauxmannDepartment of Neurology and Epileptology, Hertie Institute for Clinical Brain Research, University of Tuebingen, Hoppe-Seyler-Str. 3, 72076, Tuebingen, Germany. stephan.lauxmann@uni-tuebingen.de.ORCID http://orcid.org/0000-0002-9194-1716
David HeuerDepartment of Neurology and Epileptology, Hertie Institute for Clinical Brain Research, University of Tuebingen, Hoppe-Seyler-Str. 3, 72076, Tuebingen, Germany.
Jan HeckelmannDepartment of Epileptology and Neurology, RWTH Aachen University Hospital, Aachen, Germany.
Florian P FischerDepartment of Epileptology and Neurology, RWTH Aachen University Hospital, Aachen, Germany.
Melanie SchreiberDepartment of Neurology and Epileptology, Hertie Institute for Clinical Brain Research, University of Tuebingen, Hoppe-Seyler-Str. 3, 72076, Tuebingen, Germany.
Elisabeth SchriewerDepartment of Epileptology and Neurology, RWTH Aachen University Hospital, Aachen, Germany.
Guido WidmanDepartment of Epileptology and Neurology, RWTH Aachen University Hospital, Aachen, Germany.
Yvonne WeberDepartment of Epileptology and Neurology, RWTH Aachen University Hospital, Aachen, Germany.
Holger LercheDepartment of Neurology and Epileptology, Hertie Institute for Clinical Brain Research, University of Tuebingen, Hoppe-Seyler-Str. 3, 72076, Tuebingen, Germany.
Michael AlberDepartment of Pediatric Neurology and Developmental Medicine, University Children's Hospital, Tuebingen, Germany.
Sigrid Schuh-HoferDepartment of Neurology and Epileptology, Hertie Institute for Clinical Brain Research, University of Tuebingen, Hoppe-Seyler-Str. 3, 72076, Tuebingen, Germany.
Stefan WolkingDepartment of Epileptology and Neurology, RWTH Aachen University Hospital, Aachen, Germany.

Funding

Bundesministerium für Bildung und Forschung BMBF, 01GM2210BDeutsche Forschungsgemeinschaft FOR-2715, Le1030/15-1
6 · The paper itself

Abstract

backgroundClinical trials have shown that cenobamate (CNB) is an efficacious and safe anti-seizure medication (ASM) for drug-resistant focal epilepsy. Here, we analyzed one of the largest real-world cohorts, covering the entire spectrum of epilepsy syndromes, the efficacy and safety of CNB, and resulting changes in concomitant ASMs.

methodsWe conducted a retrospective observational study investigating CNB usage in two German tertiary referral centers between October 2020 and June 2023 with follow-up data up to 27 months of treatment. Our primary outcome was treatment response. Secondary outcomes comprised drug response after 12 and 18 months, seizure freedom rates, CNB dosage and retention, adverse drug reactions (ADRs), and changes in concomitant ASMs.

results116 patients received CNB for at least two weeks. At 6 months, 98 patients were eligible for evaluation. Thereof 50% (49/98) were responders with no relevant change at 12 and 18 months. Seizure freedom was achieved in 18.4% (18/98) at 6 months, 16.7% (11/66), and 3.0% (1/33) at 12 and 18 months. The number of previous ASMs did not affect the seizure response rate. Overall, CNB was well-tolerated, however, in 7.7% (9/116), ADRs led to treatment discontinuation. The most frequent changes of concomitant ASMs included the discontinuation or reduction of sodium channel inhibitors, clobazam reduction, and perampanel discontinuation, while brivaracetam doses were usually left unchanged.

conclusionsCNB proved to be a highly effective and generally well-tolerated ASM in patients with severe drug-resistant epilepsy, comprising a broad array of epilepsy syndromes beyond focal epilepsy.

Indexed as

AnticonvulsantsCarbamatesChlorophenolsDrug Resistant EpilepsyAdolescentAdultAgedFemaleGermanyHumansMaleMiddle AgedNitrilesRetrospective StudiesTetrazolesYoung AdultAnticonvulsantsCarbamatesCenobamateChlorophenolsNitrilesTetrazolesAdverse drug reactionsAnti-seizure medicationCenobamateDrug-resistant epilepsy

Identifiers

PMID38954033
PMCPMC11447096

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.