NCT05859854Active, not recruiting
Cenobamate in Adults With Focal-Onset Seizures
Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian
Source: ClinicalTrials.gov · Last updated 8 Sept 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 936 (actual)
- First submitted
- 26 Apr 2023
- Start date
- 24 Jan 2023
- Primary completion date
- Dec 2025
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Diseases
- Epilepsy
- NCT number
- NCT05859854
What you commit to
- Study type: Observational
- Participants enrolled: 936
- From 24 Jan 2023 to the primary completion date, Dec 2025
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 Johnson syndrome
- Patients enrolled in a clinical trial in which treatments for epilepsy are managed through a study protocol
Lab values
- Patients diagnosed with familial short-QT syndrome
Other
- Patient unable to read and write in Italian language and to autonomously fill in questionnaires and scales
- Patients with a known pregnancy or who are breast-feeding from cenobamate treatment initiation till enrolment visit.
Who the study is looking for
- 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-
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico di Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Università degli Studi di Catanzaro "Magna Graecia" Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| Associazione La Nostra Famiglia - IRCCS Eugenio Medea Coordinator of this site? Confirm its status | Conegliano | Italy | Unknown status |
| Fondazione Istituto Neurologico Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| IRCCS Neuromed Coordinator of this site? Confirm its status | Pozzilli | Italy | Unknown status |
| Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| Humanitas Gradenigo Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| Azienda Sanitaria Universitaria (A.O.U.) Integrata Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Ospedale San Bortolo Coordinator of this site? Confirm its status | Vicenza | Italy | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.