Evidence map›Paper›PMID 41704210›Full record

ArticleEuropean journal of neurology2026

Real-World Use of Cenobamate in Paediatric Drug-Resistant Epilepsy: Long-Term Efficacy, Safety, and Co-Medication Adjustment.

Tiziana Pisano, Simona Balestrini, Alessandra Boncristiano, Saverio Caini, Martina Lombardini, Erica Scuma, Mara Cavallin, Luca Bartolini, Simona Pellacani, Carmen Barba and 1 more

Abstract read
In one paragraph

Article in European journal of neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

11 authors.

Tiziana PisanoNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.ORCID 0000-0001-8920-9078
Simona BalestriniNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.
Alessandra BoncristianoNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.
Saverio CainiCancer Risk Factors and Lifestyle Epidemiology Unit, Institute for Cancer Research, Prevention, and Clinical Network (ISPRO), Florence, Italy.
Martina LombardiniNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.
Erica ScumaNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.
Mara CavallinNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.
Luca BartoliniNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.ORCID 0000-0003-2755-8218
Simona PellacaniNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.
Carmen BarbaNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.ORCID 0000-0001-5445-5842
Renzo GuerriniNeuroscience and Human Genetics Department, Meyer Children's Hospital IRCCS, Florence, Italy.ORCID 0000-0002-7272-7079

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe evaluated the real-world efficacy, tolerability, treatment retention, and quality-of-life effects of cenobamate in paediatric drug-resistant epilepsy.

methodsWe retrospectively studied 78 paediatric patients with drug-resistant epilepsy treated with cenobamate for ≥ 3 months at a tertiary epilepsy centre. We assessed seizure frequency, adverse effects, cognitive/behavioural outcomes, and changes in concomitant antiseizure medications. The primary efficacy endpoint was a ≥ 50% reduction in seizure frequency. We assessed safety through reported adverse events and clinical improvement using the Clinical Global Impression-Improvement (CGI-I) scale. We used Kaplan-Meier analyses to assess responder rates and treatment retention over 18 months.

resultsA ≥ 50% seizure reduction was achieved in 67.9% of patients including 6.4% who became seizure-free. Polytherapy was simplified in 38% overall and in 56.6% of responders. Adverse events occurred in 43.6% of patients, were mostly mild, and led to discontinuation in only one patient (1.3%). CGI-I indicated clinical improvement in 24.4%. Kaplan-Meier analysis showed sustained response in 93% of initial responders at 18 months. Treatment retention remained high: 94.7% at 3 months, 89.6% at 12 months, and 86.8% at 18 months. Median follow-up was 12 months (range 3-18), with 60.3% followed for ≥ 12 months and 41% for the full 18 months.

conclusionsOur study confirms and extends recent evidence on the efficacy and favourable tolerability of cenobamate in paediatric drug-resistant epilepsy. We observed functional improvements and polytherapy simplification, suggesting broader therapeutic benefits. These findings warrant prospective validation in specific paediatric epilepsy syndromes and may help support regulatory approval for paediatric use.

Indexed as

AnticonvulsantsCarbamatesChlorophenolsDrug Resistant EpilepsyTetrazolesAdolescentChildChild, PreschoolDrug Therapy, CombinationFemaleHumansKaplan-Meier EstimateMaleQuality of LifeRetrospective StudiesTreatment OutcomeAnticonvulsantsCarbamatesCenobamateChlorophenolsTetrazolescenobamatedrug‐resistant epilepsypaediatric epilepsyquality of lifereal‐world evidence

Identifiers

PMID41704210
PMCPMC12914351

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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.