Cenobamate treatment for adults with focal-onset seizures
Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian
This study is testing how well cenobamate works for adults in Italy with uncontrolled focal seizures who haven't found relief from other epilepsy medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Aziende Chimiche Riunite Angelini Francesco S.p.A Industry-sponsored |
| Locations | 10 sites (Pozzilli, Isernia and 9 other locations) |
| Trial ID | NCT05859854 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather real-world data on the effectiveness, safety, and tolerability of cenobamate in adult patients with uncontrolled focal epilepsy in Italy. It will analyze the clinical profile of patients who have not responded to at least two antiepileptic medications and have been treated with cenobamate for a period of 52 weeks. The study will assess changes in seizure frequency and other relevant factors such as age, treatment setting, and dosage of cenobamate. Data will be collected from medical charts and seizure diaries to provide a comprehensive understanding of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with uncontrolled focal epilepsy despite prior treatment with at least two antiepileptic medications.
Not a fit: Patients who have not received prior treatment with at least two antiepileptic medications or those with other types of seizures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness of cenobamate, potentially leading to improved treatment options for patients with uncontrolled focal epilepsy.
How similar studies have performed: Other studies have shown promising results with similar approaches in evaluating the effectiveness of new treatments for epilepsy, suggesting that this study could build on existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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 Johnson syndrome * Patients enrolled in a clinical trial in which treatments for epilepsy are managed through a study protocol * 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.
Where this trial is running
Pozzilli, Isernia and 9 other locations
- IRCCS Neuromed — Pozzilli, Isernia, Italy (Recruiting)
- Associazione La Nostra Famiglia - IRCCS Eugenio Medea — Conegliano, Treviso, Italy (Recruiting)
- Policlinico di Bari — Bari, Italy (Recruiting)
- Università degli Studi di Catanzaro "Magna Graecia" — Catanzaro, Italy (Recruiting)
- Fondazione Istituto Neurologico Casimiro Mondino — Pavia, Italy (Recruiting)
- Campus Bio-Medico — Roma, Italy (Recruiting)
- Policlinico Umberto I — Roma, Italy (Recruiting)
- Humanitas Gradenigo — Torino, Italy (Recruiting)
- Azienda Sanitaria Universitaria (A.O.U.) Integrata — Udine, Italy (Recruiting)
- Ospedale San Bortolo — Vicenza, Italy (Recruiting)
Study contacts
- Study coordinator: Valentina Villano, MD
- Email: valentina.villano@angelinipharma.com
- Phone: +390691045340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.