An observational study in Focal Epilepsy With and Without Secondary Generalization, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Observational
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).
766 studies on the registry are indexed under Seizures; 136 are open to participants now.
This study's planned enrollment of 300 is above the median of 140 across 216 observational studies indexed under Seizures.
Browse Seizures studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
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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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
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.
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 treatment
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 treatment
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 treatment
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 treatment
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 treatment
Sleepiness status evaluation
To describe the sleepiness status of patients, by means of the Epworth Sleepiness Scale (ESS), at 6 and at 12 months of maintenance-dosing treatment with cenobamate. The ESS scale is designed to measure the patient's general level of daytime sleepiness. The ESS scale is designed to measure the patient's general level of daytime sleepiness and consists of 8 questions with a rating ranging from "0 = no chance of dozing" to "3 = high chance of dozing".
Time frame: At 6 and at 12 months of maintenance-dosing treatment
Healthcare resource evaluation
Absolute and relative frequencies of patients according to the type of resources used (ED accesses; inpatient hospitalizations; specialist outpatient visits; diagnostic exams) during the observation period. Descriptive statistics (mean, SD, median, 25th and 75th percentiles, min. and max.) of total number of resources used (ED accesses; inpatient hospitalizations; specialist outpatient visits; diagnostic exams) during the observation period. Descriptive statistics (mean, SD, median, 25th and 75th percentiles, min. and max.) of total duration of inpatient hospitalizations (calculated for each patient by summing the duration of all his/her inpatient hospitalizations) during the observation period.
Time frame: 0-12 months of maintenance-dosing treatment
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