Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cenobamate.
- Who it may be relevant to
- Registry conditions: Focal Epilepsy With and Without Secondary Generalization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Drug 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.
Primary outcome measures
- Responder rate [Time frame: At 6 and at 12 months of maintenance treatment]
Secondary outcome measures (6)
- Responder rate [Time frame: At 6 and at 12 months of maintenance-dosing treatment]
- Safety evaluation [Time frame: 0 -12 months of maintenance-dosing treatment]
- Health-Related Quality of Life evaluation (QOLIE-31-P) [Time frame: At 6 and at 12 months maintenance-dosing treatment]
- Health-Related Quality of Life evaluation (SF-6Dv2 ) [Time frame: At 6 and at 12 months maintenance-dosing treatment]
- Sleepiness status evaluation [Time frame: At 6 and at 12 months of maintenance-dosing treatment]
- Healthcare resource evaluation [Time frame: 0-12 months of maintenance-dosing treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital TARNIER COCHIN — Paris
Identifiers
NCT: NCT06716801 · 169(A)MD23324