Focal Epilepsy With and Without Secondary GeneralizationNCT06716801
Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
An observational study of Focal Epilepsy With and Without Secondary Generalization, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Epilepsy With and Without Secondary Generalization
- What is being tested?
- Cenobamate
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital TARNIER COCHIN
Paris, France
Edouard HIRSCH
About this study
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
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).
- Being tested
- Cenobamate
- Keywords
- focal-onset seizures, epilepsy
- Medical subject headings
- Seizures, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenobamateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients affected by epilepsy with focal-onset seizures with or without secondary generalization | 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). Receives: Drug: Cenobamate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 6 and at 12 months of maintenance treatment
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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.
Measured: 0-12 months of maintenance-dosing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start19 Dec 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Focal Epilepsy With and Without Secondary GeneralizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716801
- Sponsor's protocol ID
- 169(A)MD23324
- Status last verified
- Nov 2024
- First submitted
- 22 Nov 2024
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06716801
- Acronym / sponsor ID
- 169(A)MD23324
- Keywords
- focal-onset seizures, epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients affected by epilepsy with focal-onset seizures with or without secondary generalization | – | Drug: CenobamateAdult 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenobamateAdult 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. | Drug | Patients affected by epilepsy with focal-onset seizures with or without secondary generalization |
Primary outcome
Responder rate
Time frame: At 6 and at 12 months of maintenance treatment
To describe the ≥50% responder rate during the 6 and 12 months of maintenance-dosing treatment with cenobamate with respect to the pretreatment baseline.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Epilepsy With and Without Secondary Generalization, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valeria Tellone (+393452493461, valeria.tellone@angelinipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Responder rate (time frame: At 6 and at 12 months of maintenance treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.