Early add-on cenobamate for adults with focal epilepsy 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

This study will see if adding cenobamate early as an extra medicine helps adults with focal epilepsy in France, Germany, and Spain who weren't controlled on 2–3 prior anti-seizure medicines.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A (Industry-sponsored)
• Locations: 1 site (Paris, France)
• Trial ID: NCT06716801 on ClinicalTrials.gov

What this trial studies

This is an observational, real-world project collecting retrospective and routine clinical data from adults with focal-onset seizures who start cenobamate as a third or fourth-line adjunctive therapy. Investigators will use medical charts, seizure diaries, and clinic notes to document seizure frequency, dosing/titration status, and concomitant anti-seizure medications. The cohort includes patients from clinical sites in France, Germany, and Spain who had inadequate control on two or three prior ASMs. Outcomes focus on clinical response and tolerability during the titration and early maintenance periods.

Who should consider this trial

Good fit: Adults (≥18) with focal-onset seizures not adequately controlled after two or three prior ASMs who are starting cenobamate as a third- or fourth-line adjunct and have reliable seizure-frequency records.

Not a fit: Patients who are already seizure-free on current therapy, those with primarily generalized epilepsy, or those without reliable three-month seizure records are unlikely to gain benefit from participating.

Why it matters

Potential benefit: If successful, the findings could show that early add-on cenobamate reduces seizure frequency and is tolerable in routine clinical practice, supporting its earlier use.

How similar studies have performed: Randomized clinical trials of cenobamate have shown substantial seizure reductions in focal epilepsy and emerging real-world reports generally support those results.

Eligibility criteria

Inclusion Criteria:

1. Male and female patients ≥18 years old at the time of cenobamate treatment initiation.
2. Patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization.
3. Patients under titration phase (i.e., maintenance dose not reached yet according to clinical judgement) with cenobamate as adjunctive therapy in third or fourth line with 1 to maximum 2 (for third line)/3 (for fourth line) concomitant anti-seizure medications (ASMs).
4. Patients who have not been adequately controlled despite treatment with 2 or 3 (maximum) ASMs before cenobamate treatment initiation (including concomitant ASMs started before initiating cenobamate).
5. Patients with available retrospective data in medical charts, seizure diaries or patient's notes, including reliable information about seizure frequency (intended as the number of seizures and the corresponding time period) in the last 3 months before cenobamate treatment initiation.
6. Written informed consent (including consent for the processing of personal data) signed by the patient, or by the legally designated representative in case of patient lacking capacity, prior to entering the study following local regulation.

Exclusion Criteria:

1. Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC).
2. Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors.
3. Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania.
4. Patients with known substance abuse or dependence (except for caffeine and nicotine).
5. Patients participating in any interventional study from cenobamate treatment initiation until enrolment visit.
6. Patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit.
7. Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.

Where this trial is running

Paris, France

• Hôpital TARNIER COCHIN — Paris, France, France (Recruiting)

Study contacts

• Study coordinator: Valeria Tellone

Conditions Focal Epilepsy With and Without Secondary Generalization; focal-onset seizures; epilepsy