NCT06716801Recruiting
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
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 22 Nov 2024
- Start date
- 19 Dec 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Diseases
- Epilepsy
- NCT number
- NCT06716801
What you commit to
- Study type: Observational
- Planned participants: 300
- From 19 Dec 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania.
- Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.
Other illness
- Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors.
Other
- Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC).
- Patients with known substance abuse or dependence (except for caffeine and nicotine).
- Patients participating in any interventional study from cenobamate treatment initiation until enrolment visit.
- Patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit.
Who the study is looking for
- Male and female patients ≥18 years old at the time of cenobamate treatment initiation.
- Patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization.
- 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).
- 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).
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital TARNIER COCHIN Coordinator of this site? Confirm its status | Paris | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.