Observational studyEpilepsia2025
Effectiveness and safety of adjunctive cenobamate in people with focal-onset epilepsy: Interim results after 24-week observational period from the BLESS study.
Observational study in Epilepsia, 2025. 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 13 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
13 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
- Bistromathics in Epilepsy and the Relativity of Numbers.CNS drugs · 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
- 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
- Early Cenobamate as a Third-Line Option in Drug-Resistant Focal Epilepsy: A Paradigm Shift?Neurology and therapy · 2026Article
- Observational
- Long-Term Impact of Cenobamate on Cognition, Adaptive Behavior, and Quality of Life in Patients with Tuberous Sclerosis Complex.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
- Precision management of cenobamate in drug-resistant epilepsy: integrating pharmacogenetics, therapeutic drug monitoring, and real-world clinical strategies.Frontiers in pharmacology · 2026Article
- 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
- Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
54 authors.
Funding
Abstract
objectiveCenobamate is an antiseizure medication (ASM) with a dual mechanism of action that was recently approved for the treatment of focal seizures in adults. This analysis aimed to describe the outcomes at 12 and 24 weeks after starting cenobamate therapy in a real-world setting.
methodsBLESS [NCT05859854] is an ongoing, observational, retrospective and prospective cohort study to evaluate the real-world effectiveness and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy. Subgroup analysis was performed in subjects with 2 to 3 previous ASMs (early users) and those with >3 previous ASMs (late users).
resultsThe second interim analysis of the BLESS study included 388 participants with a median (interquartile range) age of 43.0 (31.0-54.0) years. They had a median of 6.0 (4.0-9.0) prior ASMs and a median of 7.2 (3.0-20.6) monthly seizures at baseline. The median monthly seizure frequency was reduced by 59.9% (19.2%-87.3%) from baseline to 24 weeks; 229 (59.0%) subjects had a ≥50% seizure frequency reduction, and 44 (11.3%) showed sustained seizure freedom. The proportion of participants taking ≤2 concomitant ASMs increased from 217 (56.5%) at baseline to 239 (65.7%) at 24 weeks. Among the early users (n = 76, 19.6%), the median reduction in monthly seizure frequency at 24 weeks was 78.0% (50.0-97.1%), and 76.3% of subjects had a ≥50% response rate. The frequency of adverse drug reactions (ADRs) was 5.3% and 23.4% in early and late users. The most frequent ADRs were somnolence, dizziness, and balance disorder; after the occurrence of ADRs, 63.5% of participants maintained the prescribed dose, and 5.2% permanently discontinued treatment. SIGNIFICANCE: Cenobamate was effective in reducing seizure frequency in a real-world setting and showed a manageable safety profile. The treatment with cenobamate also reduced the burden of concomitant ASMs in both early and late users.
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