Clinical trial NCT06716801: Real-world Clinical Response to Cenobamate Early Add-on in France, Germany and Spain
Official title: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Focal Epilepsy with and Without Secondary Generalization
Keywords: focal-onset seizures
epilepsy
Lead sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A
Sponsor class: INDUSTRY
Collaborators: name: Iqvia Pty Ltd
First posted: 2024-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 (ASMs).

Brief 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 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.

Primary outcomes:
measure: Responder rate
timeFrame: At 6 and at 12 months of maintenance treatment
Secondary outcomes:
measure: Responder rate
timeFrame: At 6 and at 12 months of maintenance-dosing treatment
measure: Safety evaluation
timeFrame: 0 -12 months of maintenance-dosing treatment
measure: Health-Related Quality of Life evaluation (QOLIE-31-P)
timeFrame: At 6 and at 12 months maintenance-dosing treatment
measure: Health-Related Quality of Life evaluation (SF-6Dv2 )
timeFrame: At 6 and at 12 months maintenance-dosing treatment
measure: Sleepiness status evaluation
timeFrame: At 6 and at 12 months of maintenance-dosing treatment
measure: Healthcare resource evaluation
timeFrame: 0-12 months of maintenance-dosing treatment
Other outcomes:
Locations:
Study officials:
References: