NCT05859854

Cenobamate in Adults With Focal-Onset Seizures

Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 936 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The main objective of the study is to describe the effectiveness of adjunctive cenobamate treatment in adult patients with uncontrolled focal epilepsy in Italy, overall and according to age class, setting of cenobamate treatment, cenobamate final target daily dose prescribed, and number of concomitant Anti Seizure Medications (ASMs). This will be assessed by intra-patient percent change and achievement of a ≥50% reduction in the seizure frequency from the pre-treatment baseline over a period of 52 weeks.

Conditions

• Epilepsy
• Focal-Onset Seizure
• Neurological Disorder

Timeline

• Start date: 2023-01-24
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-05-16
• Last updated: 2025-09-08

Locations

10 sites across 1 country: Italy