Clinical Trial

Cenobamate in Adults With Focal-Onset Seizures

Study acronym: BLESS
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated September 8, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
The BLESS Study contributes to filling this information gap by collecting data from the Italian clinical practice and the Compassionate Use Program, to better characterize the clinical profile of cenobamate describing its effectiveness, safety and tolerability in adult patients diagnosed with uncontrolled focal epilepsy despite the use of at least two antiepileptic medicinal products.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-05-05; most recent amendment 2025-09-01.
Status change: Recruiting → Active, Not Recruiting 2025-09-01
Trial Details
NCT Number NCT05859854
Lead Sponsor Aziende Chimiche Riunite Angelini Francesco S.p.A
Collaborators: IQVIA Pty Ltd
Conditions Epilepsy, Focal-Onset Seizure, Neurological Disorder
Enrollment 936 participants
Start Date 2023-01-24
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-09-08