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
This trial does not accept healthy volunteersQualifiers
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 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).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cenobamate
DrugAdult 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients affected by epilepsy with focal-onset seizures with or without secondary generalization1 intervention
Trial outcomes
Primary outcomes
1
Responder rate
To describe the ≥50% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pretreatment baseline.
Time frame
At 6 and at 12 months of maintenance treatmentSecondary outcomes
1
Responder rate
To describe the ≥75%/≥90%/=100% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pre-treatment baseline.
Time frame
At 6 and at 12 months of maintenance-dosing treatment2
Safety evaluation
To describe real-world safety from treatment initiation until 12 months of maintenance-dosing treatment with cenobamate. Absolute and relative frequencies of patients treated with cenobamate who experienced at least one AE/Adverse Drug Reaction (ADR)/Serious Adverse Event (SAE)/Serious Adverse Drug Reaction (SADR)/AE of special interest during the observation period. Total number of AEs/ADRs/SAEs/SADRs/AEs of special interest occurred during the observation period.
Time frame
0 -12 months of maintenance-dosing treatment3
Health-Related Quality of Life evaluation (QOLIE-31-P)
QOLIE-31-P is a survey of health-related quality of life for adults with epilepsy. This questionnaire should be completed only by the person who has epilepsy (not a relative or friend). There are 39 questions about health and daily activities.The QOLIE-31-P consists of 38 self-reported items and is divided in eight parts which evaluate energy, mood, daily activities, cognition, medication effects, seizure worry, overall QoL , and health state. The first and the last items are scored with 0-10 and 0-100 scales, respectively, from the worst to the best situation. The remaining 36 items are scored using a Likert rating scale from 1 to 3,4,5, or 6. The raw scores are reorganized to have scores from 0 to 100. The final score is obtained from the subscale scores and is rescaled from 0 to 100 with higher scores associated with better QoL.
Time frame
At 6 and at 12 months maintenance-dosing treatment4
Health-Related Quality of Life evaluation (SF-6Dv2 )
The SF-6Dv2 Health Utility Survey provides keen insights into patient health and product performance by measuring six health domains. The SF-6Dv2™ Health Survey consists of six questions asking about different aspects of patient's health; for each question, patients should select the response (among 5 or 6 options per question) that best describe his/her health status.
Time frame
At 6 and at 12 months maintenance-dosing treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aziende Chimiche Riunite Angelini Francesco S.p.A
Lead sponsor
IQVIA Pty Ltd
Collaborator
Source ClinicalTrials.gov