Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
Recruiting · NCT06716801 · Observational (researchers observe without assigning treatment) · Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC).
- Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors.
- Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania.
- 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.
- Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.
Where it is running
1 location listed.
- Hôpital TARNIER COCHIN - Paris, France, France