Observational studyEpilepsia open2023
Real-world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program.
Observational study in Epilepsia open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Who cites it
53 citing papers in PubMed, 1 synthesis or guideline pooled it, 79 citations in OpenAlex.
- [Advances and guidance in the treatment of drug-resistant epilepsy: a review by the Andalusian Epilepsy Society of the new drugs cenobamate, fenfluramine and cannabidiol].Revista de neurologia · 2024Guideline
- Efficacy and Safety of Adjunctive Cenobamate in Chinese Participants with Focal Seizure.Advances in therapy · 2026Trial
- Bistromathics in Epilepsy and the Relativity of Numbers.CNS drugs · 2026Article
- Positioning Cenobamate in the Treatment Algorithm of Focal Epilepsy: Seizure Control and Benefits Beyond Seizures.Neurology and therapy · 2026Review
- Exploring the Role of Early Add-On Cenobamate in Uncontrolled Focal Epilepsy: A Critical Appraisal of the Evidence.Neurology and therapy · 2026Review
- DECREASE study: A European pool-analysis of patients with significant reductions in concomitant antiseizure medications in cenobamate Early Access Programs.Epilepsia open · 2026Article
- Sustained seizure reduction, treatment simplification, and high retention with cenobamate: A 12-month real-world study in refractory and ultra-refractory focal epilepsy.Epilepsia open · 2026Article
- Cenobamate: An Appraisal Five Years On.Neurology and therapy · 2026Review
- Real-world effectiveness of cenobamate in drug-resistant and ultra-refractory epilepsy: A multicenter study.Epilepsia open · 2026Observational
- Delayed and deferred surgery associated with cenobamate use in people with drug-resistant focal epilepsy.Epilepsia · 2026Article
- Effectiveness and safety of cenobamate after conversion to monotherapy or dual therapy in real-world clinical practice.Epileptic disorders : international epilepsy journal with videotape · 2026Observational
- Effectiveness of adjunctive low-dose clobazam in adults with focal drug-resistant epilepsy and incomplete response to cenobamate: A real-world study.Epilepsia open · 2026Article
- Review
- Cenobamate in pediatric drug-resistant epilepsy: real-world evidence from a two-center retrospective study.European journal of pediatrics · 2026Article
- Observational
- Impact of long-term treatment with cenobamate on concomitant usage of antiseizure medications: A real-world retrospective study in Spain.Epilepsia · 2026Observational
- Long-term Impact of Cenobamate on Cognition in Patients with Drug-Resistant Focal Epilepsy: Outcomes from an Exploratory Real-World Study.Neurology and therapy · 2026Article
- Real-World Use of Cenobamate in Paediatric Drug-Resistant Epilepsy: Long-Term Efficacy, Safety, and Co-Medication Adjustment.European journal of neurology · 2026Article
- Observational
- Precision management of cenobamate in drug-resistant epilepsy: integrating pharmacogenetics, therapeutic drug monitoring, and real-world clinical strategies.Frontiers in pharmacology · 2026Article
Corrections and comments
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Authors and funding
20 authors at 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study investigated early, real-world outcomes with cenobamate (CNB) in a large series of patients with highly drug-resistant epilepsy within a Spanish Expanded Access Program (EAP).
methodThis was a multicenter, retrospective, observational study in 14 hospitals. Inclusion criteria were age ≥18 years, focal seizures, and EAP authorization. Data were sourced from patient clinical records. Primary effectiveness endpoints included reductions (100%, ≥90%, ≥75%, and ≥50%) or worsening in seizure frequency at 3-, 6-, and 12-month visits and at the last visit. Safety endpoints included rates of adverse events (AEs) and AEs leading to discontinuation.
resultsThe study included 170 patients. At baseline, median epilepsy duration was 26 years and median number of seizures/month was 11.3. The median number of prior antiseizure medications (ASMs) and concomitant ASMs were 12 and 3, respectively. Mean CNB dosages/day were 176 mg, 200 mg, and 250 mg at 3, 6, and 12 months. Retention rates were 98.2%, 94.5%, and 87% at 3, 6, and 12 months. At last available visit, the rate of seizure freedom was 13.3%; ≥90%, ≥75%, and ≥50% responder rates were 27.9%, 45.5%, and 63%, respectively. There was a significant reduction in the number of seizures per month (mean: 44.6%; median: 66.7%) between baseline and the last visit (P < 0.001). Responses were maintained regardless of the number of prior or concomitant ASMs. The number of concomitant ASMs was reduced in 44.7% of patients. The cumulative percentage of patients with AEs and AEs leading to discontinuation were 68.2% and 3.5% at 3 months, 74.1% and 4.1% at 6 months, and 74.1% and 4.1% at 12 months. The most frequent AEs were somnolence and dizziness. SIGNIFICANCE: In this highly refractory population, CNB showed a high response regardless of prior and concomitant ASMs. AEs were frequent but mostly mild-to-moderate, and few led to discontinuation.
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