ArticleNeurology and therapy2024
Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study.
Article in Neurology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05859854 (Cenobamate in Adults With Focal-Onset Seizures), which is not on this map. Cited by 11 papers.
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.
Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian
Who cites it
11 citing papers in PubMed.
- Exploring the Role of Early Add-On Cenobamate in Uncontrolled Focal Epilepsy: A Critical Appraisal of the Evidence.Neurology and therapy · 2026Review
- Cenobamate Improves Emotional Dysregulation, Impulsivity, and Apathy in Drug-Resistant Focal Epilepsy: A Longitudinal Neuropsychological Study.Neurology and therapy · 2026Article
- Real-world effectiveness of cenobamate in drug-resistant and ultra-refractory epilepsy: A multicenter study.Epilepsia open · 2026Observational
- Seizure freedom as a transitional phase of recovery: rethinking the burden of normality in epilepsy integrating medical and lived perspectives in post-remission care.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2026Article
- Observational
- Early antiseizure response to cenobamate (200 mg/day) in focal drug-resistant epilepsy: a retrospective single-center analysis.Epilepsy & behavior reports · 2025Article
- Early Introduction of Cenobamate in Uncontrolled Focal Epilepsy: Insights from a Structured Controversy.Neurology and therapy · 2025Article
- Cenobamate: A Review in Focal-Onset Seizures.CNS drugs · 2025Review
- Observational
- Cenobamate for Difficult-to-Treat Epilepsy - Selected Case Vignettes.Neuropsychiatric disease and treatment · 2025Article
- Cenobamate, a New Promising Antiseizure Medication: Experimental and Clinical Aspects.International journal of molecular sciences · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDespite new anti-seizure medications (ASMs) being introduced into clinical practice, about one-third of people with epilepsy do not reach seizure control. Cenobamate is a novel tetrazole-derived carbamate compound with a dual mechanism of action. In randomized controlled trials, adjunctive cenobamate reduced the frequency of focal seizures in people with uncontrolled epilepsy. Studies performed in real-world settings are useful to complement this evidence and better characterize the drug profile.
methodsThe Italian BLESS ("Cenobamate in Adults With Focal-Onset Seizures") study is an observational cohort study aimed to evaluate the effectiveness, tolerability, and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy in the context of real-world clinical practice. The study is ongoing and conducted at 50 centers in Italy. This first interim analysis includes participants enrolled until June 2023 and with 12-week outcome data available.
resultsForty participants with a median age of 36.5 (interquartile range [IQR] 26.0-47.5) years were included. The median monthly seizure frequency at baseline was 6.0 (IQR 2.5-17.3) seizures and 31 (77.5%) participants had failed four or more ASMs before cenobamate. At 12 weeks from starting cenobamate, the median reduction in monthly seizure frequency was 52.8% (IQR 27.1-80.3%); 22 (55.0%) participants had a ≥ 50% reduction in baseline seizure frequency and six (15.0%) reached seizure freedom. The median number of concomitant ASMs decreased from 3 (IQR 2-3) at baseline to 2 (IQR 2-3) at 12 weeks and the proportion of patients treated with > 2 concomitant ASMs decreased from 52.5% to 40.0%. Seven (17.5%) patients reported a total of 12 adverse events, 11 of which were considered adverse drug reactions to cenobamate.
conclusionIn adults with uncontrolled focal seizures, the treatment with adjunctive cenobamate was well tolerated and was associated with improved seizure control and a reduction of the burden of concomitant ASMs. TRIAL REGISTRATION NUMBER: NCT05859854 (ClinicalTrials.gov Identifier).
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