Cenobamate in Adults With Focal-Onset Seizures (NCT05859854) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Cenobamate in Adults With Focal-Onset Seizures
Italy936 participantsStarted 2023-01-24
Plain-language summary
The BLESS Study contributes to filling this information gap by collecting data from the Italian clinical practice and the Compassionate Use Program, to better characterize the clinical profile of cenobamate describing its effectiveness, safety and tolerability in adult patients diagnosed with uncontrolled focal epilepsy despite the use of at least two antiepileptic medicinal products.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥18 years at the time of cenobamate treatment initiation
* Male or female patients
* Patients diagnosed with focal epilepsy uncontrolled despite a history of treatment with at least two antiepileptic medicinal products at the time of cenobamate treatment initiation in agreement with the Summary of Product Characteristics (SmPC)
* Patients who at enrolment had received at least 12 weeks (titration period up to the initial recommended target dose of 200 mg daily completed) but no more than 52 weeks of cenobamate as adjunctive treatment of focal-onset seizures with or without secondary generalization
* Patients with available retrospective data in medical charts and seizure diaries, including information about baseline seizure frequency prior to cenobamate treatment initiation
* Patients who gave written informed consent to take part into the study and personal data processing consent following local regulation.
* Patients who received adjunctive cenobamate for at least 12 weeks and discontinued permanently treatment before enrolment will also be included in the study-
Exclusion Criteria:
* Patients diagnosed with familial short-QT syndrome
* Patients affected by hypersensitivity to the active substance cenobamate or to any of the excipients (e.g., lactose monohydrate)
* Patients with history of severe drug-induced hypersensitivity reaction, including (but not limited to) drug reaction with eosinophilia and systemic symptoms (DRESS), and Stevens John…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure frequency (overall)
Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation
2
Relative frequency of patients achieving a ≥50% (50% or greater) reduction in the seizure frequency (overall)
Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation
3
Intra-patient percent change in the seizure frequency (overall)
Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation
4
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure (stratified)
Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation
5
Relative frequency of patients achieving a ≥50% (50% or greater) reduction in the seizure frequency (stratified)
Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation
6
Intra-patient percent change in the seizure frequency (stratified)
Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation
Trial details
NCT IDNCT05859854
SponsorAziende Chimiche Riunite Angelini Francesco S.p.A