Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A
About this trial
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 criteria
Qualifiers
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).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Cenobamate
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov