NCT06716801

Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

Observational Cohort Study on Adult Patients With Not-adequately Controlled FOcal-onset Seizures Treated With Cenobamate as Early adjUnctive Therapy in a Real-world Setting - FOCUS

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of the study is to better characterize the clinical profile of adjunctive cenobamate by collecting data from the current standard clinical practice in France, Germany, and Spain, to describe the real-world clinical response among adult patients affected by focal epilepsy not adequately controlled despite a history of 2 or 3 ASMs before starting treatment with cenobamate (including previous and concomitant ASMs).

Conditions

• Focal Epilepsy With and Without Secondary Generalization

Interventions

Type	Name	Description
DRUG	Cenobamate	Adult patients affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications.

Timeline

• Start date: 2024-12-19
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2024-12-04
• Last updated: 2025-09-19

Locations

1 site across 1 country: France