Beyond seizure control: Non-seizure-related outcomes in focal-onset epilepsy treated with adjunctive cenobamate. Third interim results from the BLESS study.

Lattanzi S, d'Orsi G, Di Claudio MT, +58 more, BLESS Study Group.

Journal ArticleAbstract only — full text under license

AI summary — for doctors, generated from the abstract only

In real-world use, patient-reported quality of life, sleepiness and mood stayed stable through 52 weeks of adjunctive cenobamate, and clinicians rated most patients as improved.

What was studied

Third interim analysis of BLESS, an observational retrospective and prospective cohort of 377 adults with uncontrolled focal epilepsy on adjunctive cenobamate, assessing QOLIE-31, Epworth Sleepiness Scale, HADS and CGI up to 52 weeks.

Key findings

QOLIE-31 overall score remained stable at 12, 24 and 52 weeks; sustained seizure freedom at 24 weeks was linked to higher overall QOLIE-31 (p = 0.041) and cognitive functioning (p = 0.019)
More than 68% had normal daytime sleepiness and no anxiety or depression by HADS at each assessment
Clinicians rated 91.3%, 85.7% and 87.4% as improved on CGI-I at 12, 24 and 52 weeks

Clinical relevance

The results are reassuring that non-seizure outcomes did not worsen, and they highlight the link between seizure freedom and quality of life and cognition. They do not show that cenobamate itself improved those outcomes.

Who should care

Neurology

Limitations

Uncontrolled, interim, descriptive data with different numbers at each timepoint (for example 197, 363 and 197), so attrition and selection bias are possible. Clinician ratings are subjective, and the comparison with sustained seizure freedom is not causal.

Outcomes beyond seizure counts appear stable with adjunctive cenobamate, but this is preliminary, uncontrolled evidence.

This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.

Abstract

Objective

Cenobamate is approved for treatment of focal seizures in adults, but evidence on non-seizure outcomes remains limited. This interim statistical analysis of the cenoBamate in aduLts with focal-onsEt SeizureS (BLESS) study evaluated patient- and clinician-reported outcomes for up to 52 weeks of cenobamate treatment.

Methods

BLESS is an observational, retrospective and prospective cohort study designed to assess the real-world effectiveness and safety of adjunctive cenobamate in adults with uncontrolled focal epilepsy. Outcomes included patient-reported health-related quality of life, sleepiness, anxiety, mood, and global functioning assessed by the 31-item Quality of Life in Epilepsy Inventory (QOLIE-31), the Epworth Sleepiness Scale (ESS), the Hospital Anxiety and Depression Scale (HADS), and the Clinical Global Impression (CGI) scales.

Results

A total of 377 participants were included. Among subjects with an available score at 12 (n = 197), 24 (n = 363), and 52 (n = 197) weeks, the QOLIE-31 overall score remained stable. Subjects with sustained seizure freedom at 24 weeks showed a significantly higher QOLIE-31 overall score (p = 0.041) and cognitive functioning scores (p = 0.019) compared with those who did not reach sustained seizure freedom. More than 68% of participants had normal daytime sleepiness (total ESS score 0-10) and did not report anxiety or depression according to the HADS-A and HADS-D subscales at each assessment up to 52 weeks. Clinicians rated 91.3% (n/N = 179/196), 85.7% (n/N = 300/350), and 87.4% (n/N = 167/191) of subjects as improved for their overall condition from the initiation of treatment according to the CGI-Improvement or change (CGI-I) scale, at 12, 24, and 52 weeks.

Significance

This interim analysis provides preliminary descriptive evidence on non-seizure outcomes in subjects treated with adjunctive cenobamate. Patient-reported outcome scores remained stable from 12 weeks and up to 52 weeks, consistent with preserved overall well-being. Better quality of life and cognitive functioning emerged in sustained vs non-sustained seizure-free participants. Based on clinicians' judgment, there was signal of improvement in overall condition compared to baseline in most treated subjects throughout the observation period.

Study registration

NCT05859854.

DOI

10.1002/epi.70501

PMID

42879242

Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.

Want more like this?

Browse more from the feed. A free account unlocks the full feed, saving and communities.

Back to the research feed

Create a free account · Sign in