Evidence map›Paper›PMID 41603140›Full record

Observational studyEpilepsia2026

Freedon study: Real-life outcomes of cenobamate in different lines of treatment.

Vicente Villanueva, José María Serratosa, Alejandro Fernández-Cabrera, Manuel Toledo, Beatriz González-Giráldez, José C Estevez, Juan Jesús Rodríguez Uranga, Maria Machio Castelló, Maria Dolores Castro-Vilanova, Juan José Poza and 41 more

Abstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Epilepsia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
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

51 authors.

Vicente VillanuevaDepartment of Neurology, Member of ERN EPICARE, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
José María SerratosaDepartment of Neurology and Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid (IIS-FJD, UAM), Madrid, Spain.
Alejandro Fernández-CabreraDepartment of Neurology, Hospital Universitario Lucus Augusti, Lugo, Spain.ORCID https://orcid.org/0000-0002-8383-163X
Manuel ToledoDepartment of Neurology, Vall d'Hebron University Hospital and Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.
Beatriz González-GiráldezDepartment of Neurology and Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid (IIS-FJD, UAM), Madrid, Spain.
José C EstevezDepartment of Neurology, Hospital Universitario Reina Sofía, Córdoba, Spain.ORCID https://orcid.org/0000-0001-5960-8457
Juan Jesús Rodríguez UrangaDepartment of Neurology, Centro de Neurología Avanzada Sevilla, Sevilla, Spain.ORCID https://orcid.org/0009-0007-5354-1256
Maria Machio CastellóDepartment of Neurology and Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid (IIS-FJD, UAM), Madrid, Spain.
Maria Dolores Castro-VilanovaDepartment of Neurology, Hospital Álvaro Cunqueiro de Vigo, Vigo, Spain.
Juan José PozaDepartment of Neurology, Hospital Universitario de Donostia, Donostia, Spain.
Xiana Rodríguez-OsorioDepartment of Neurology, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
Kevin G HampelDepartment of Neurology, Member of ERN EPICARE, Hospital Universitario y Politécnico La Fe, Valencia, Spain.ORCID https://orcid.org/0000-0003-3582-060X
Elena FonsecaDepartment of Neurology, Vall d'Hebron University Hospital and Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.ORCID https://orcid.org/0000-0002-3895-1237
Francisco Javier López-GonzálezDepartment of Neurology, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
Mercedes GarcésDepartment of Neurology, Member of ERN EPICARE, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
Laura AbrairaDepartment of Neurology, Vall d'Hebron University Hospital and Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.ORCID https://orcid.org/0000-0002-5119-7929
Jordi CiuransDepartment of Neurology, Hospital General de Granollers, Granollers, Spain.
Daniel Campos-FernándezDepartment of Neurology, Vall d'Hebron University Hospital and Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.
Estevo SantamarinaDepartment of Neurology, Vall d'Hebron University Hospital and Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.ORCID https://orcid.org/0009-0006-3940-8953
Juan María Sanchez-CaroDepartment of Neurology, Centro de Neurología Avanzada Sevilla, Sevilla, Spain.
Lucas IacampoDepartment of Neurology, Hospital Universitario de Canarias, La Laguna, Spain.
Julia RenauDepartment of Neurology, Hospital General Universitario Castellón, Castelló, Spain.
Miguel Ángel García-QuesadaDepartment of Neurology, Hospital General Universitario de Elche, Elche, Spain.
Carla AncionesDepartment of Neurology, Hospital Nuestra Señora del Rosario y Sanitas La Zarzuela, Madrid, Spain.
María Isabel ChamorroDepartment of Neurology, Hospital Universitario Virgen de la Victoria, Málaga, Spain.
Iratxe MaestroDepartment of Neurology, Centro de Neurología Avanzada Sevilla, Sevilla, Spain.
Pablo CabezudoDepartment of Neurology, Hospital Regional Universitario de Málaga and Instituto de Investigación Biomédica de Málaga, Málaga, Spain.ORCID https://orcid.org/0000-0002-6421-5348
Raquel CalleDepartment of Neurology, Hospital Universitario Clínico San Cecilio, Granada, Spain.
Jesús MacarronDepartment of Neurology, Hospital Universitario de Burgos, Burgos, Spain.
Beatriz CabezasDepartment of Neurology, Hospital Universitario de León, León, Spain.ORCID https://orcid.org/0000-0001-6653-3027
María CarrascoDepartment of Neurology, Hospital Universitario Clínico San Cecilio, Granada, Spain.
María LópezDepartment of Neurology, Hospital General Universitario Santa Lucía, Cartagena, Spain.
Marta MarínDepartment of Neurology, Clínica Universitaria de Navarra, Pamplona, Spain.ORCID https://orcid.org/0000-0001-6839-7751
Rosa QuerolDepartment of Neurology, Hospital Universitario de Badajoz, Badajoz, Spain.
Belén BaenaDepartment of Neurology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Vanessa García-MoralesDepartment of Neurology, Hospital Universitario de Álava, Vitoria, Spain.
Samuel López-MazaDepartment of Neurology, Vall d'Hebron University Hospital and Vall d'Hebron Research Institute (VHIR), Barcelona, Spain.
Álvaro JuizDepartment of Neurology, Complexo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain.
Blanca Mercedes-AlvarezDepartment of Neurology, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Carla AmaranteDepartment of Neurology and Instituto de Investigación Sanitaria-Fundación Jiménez Díaz, Hospital Universitario Fundación Jiménez Díaz, Universidad Autónoma de Madrid (IIS-FJD, UAM), Madrid, Spain.
Ana Del VillarDepartment of Neurology, Consorcio Hospitalario Provincial de Castellón, Castelló de la Plana, Spain.
Ascensión CastilloDepartment of Neurology, Hospital General de Valencia, Valencia, Spain.
Marta Rubio-RoyDepartment of Neurology, Hospital Universitario Parc Taulí, Sabadell, Spain.
Javier Martinez-PolesDepartment of Neurology, Hospital Universitario Rey Juan Carlos, Móstoles, Spain.
Asier Gómez-IbáñezDepartment of Neurology, Clínica Universitaria de Navarra, Pamplona, Spain.
Beatriz Parejo-CarbonellDepartment of Neurology, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Anabelén Martínez GarciaDepartment of Neurology, Hospital Universitario Son Espases, Palma, Spain.
Ignacio CarreraDepartment of Neurology, Hospital Universitario Nuestra Señora de Valme, Sevilla, Spain.
Pablo IriarteDepartment of Neurology, Hospital Universitario de Donostia, Donostia, Spain.
Fátima Romero-AguileraSpanish Epilepsy Society, Madrid, Spain.
Pharmacological Therapy Working group of the Spanish Epilepsy Society and Freedon Group

Funding

Angelini PharmaSociedad Española de Epilepsia
6 · The paper itself

Abstract

objectivesCenobamate is an antiseizure medication (ASM) with proven effectiveness in individuals with highly refractory epilepsy. This study investigated the effectiveness and tolerability of cenobamate in different treatment lines and a less refractory setting.

methodsThis was a multicenter, retrospective, observational study. Adults with focal epilepsy, 2-6 prior ASMs, and ≥12 months between cenobamate initiation and database closure were included. Data from patients' charts were collected and included in the Drug-Resistant Epilepsy Registry of the Spanish Epilepsy Society using Research Electronic Data Capture. Primary effectiveness endpoints included changes in seizure frequency at 3, 6, and 12 months after cenobamate initiation according to different treatment lines. Primary safety endpoints included the percentage of patients with adverse events (AEs).

resultsIn total, 486 patients were included (mean age 42.8 years). The mean number of prior ASMs was 4.4 (2-6); the mean number of concomitant ASMs at cenobamate initiation was 2.5 (1-5). At 12 months, treatment retention was 92% and median dose was 200 mg. One-year seizure-freedom rates were 32.5%, 33.3%, 21.4%, 24.2%, and 11.4% in those treated with 2-6 prior ASMs, respectively. The proportions of patients achieving ≥50%, ≥75%, ≥90%, and 100% reductions in seizure frequency at 12 months were significantly higher in patients with 2-3 (earlier treatment lines) vs 4-6 prior ASMs (later treatment lines; p ≤ .004). Improvements in seizure severity were reported in 71.9% of patients during follow-up (82.5% and 62.1% in those with 2 and 6 prior ASMs, respectively). At 12 months, 56.4% of patients had reported AEs, with somnolence the most frequent, and 4.9% had AEs requiring cenobamate discontinuation. SIGNIFICANCE: Cenobamate was effective and well tolerated in patients who had tried 2-6 prior ASMs in a real-world setting. High effectiveness was confirmed at 1 year, with better outcomes in earlier users.

Indexed as

AnticonvulsantsCarbamatesChlorophenolsDrug Resistant EpilepsyEpilepsies, PartialTetrazolesAdultFemaleHumansMaleMiddle AgedRegistriesRetrospective StudiesTreatment OutcomeYoung AdultAnticonvulsantsCarbamatesCenobamateChlorophenolsTetrazolesantiseizure medicationepilepsyseizures

Identifiers

PMID41603140
PMCPMC13179648

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.