Cenobamate in Adults With Focal-Onset Seizures

Launched by AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO S.P.A · May 5, 2023

Keywords

ClinConnect Summary

The BLESS Study is a clinical trial looking at a medication called cenobamate for adults who have focal-onset seizures, a type of epilepsy that can be hard to control. This study aims to gather information from clinical practice in Italy to better understand how well cenobamate works, how safe it is, and how well patients tolerate it. The trial is currently recruiting participants who are at least 18 years old and have already tried two other epilepsy medications without success.

To join the study, participants need to have been diagnosed with focal epilepsy that hasn’t been controlled, even after using other treatments. They should also have been taking cenobamate for at least 12 weeks and be able to provide information about their seizures from before starting this medication. During the trial, participants will be asked to share their experiences and may need to complete some questionnaires. Importantly, this study will help doctors learn more about cenobamate's effects in real-world settings, which can ultimately benefit others living with epilepsy.

Gender

ALL

Eligibility 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.