Recruiting
Observational
Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
Condition(s) studied
Focal Epilepsy With and Without Secondary Generalization
Investigational drug(s) / intervention(s)
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.
Study 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).
Eligibility
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.
Primary outcome measure(s)
- Responder rate — At 6 and at 12 months of maintenance treatment
To describe the ≥50% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pretreatment baseline.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Hôpital TARNIER COCHIN |
Paris |
France |
Recruiting |
