Cenobamate in Adults With Focal-Onset Seizures (BLESS)

Angelini Pharma

Status: Enrolling

Conditions: Focal-Onset Seizure; Epilepsy; Neurological Disorder

Study type: Observational

Funder types: Industry

Identifiers

NCT05859854

153(A)IM21348

Details and patient eligibility

About

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.

Full description

The main objective of the study is to describe the effectiveness of adjunctive cenobamate treatment in adult patients with uncontrolled focal epilepsy in Italy, overall and according to age class, setting of cenobamate treatment, cenobamate final target daily dose prescribed, and number of concomitant Anti Seizure Medications (ASMs). This will be assessed by intra-patient percent change and achievement of a ≥50% reduction in the seizure frequency from the pre-treatment baseline over a period of 52 weeks.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,200 participants in 1 patient group

Adult patients diagnosed treated with adjunctive cenobamate in Italy.

Description:

Adult patients diagnosed with focal epilepsy uncontrolled despite the use of at least two antiepileptic medicinal products, treated with adjunctive cenobamate in Italy. A single cohort of patients will be involved in the study, enrolling both subjects who initiated cenobamate treatment in accordance with the current clinical practice, and subjects previously included in the cenobamate Compassionate Use Programme in Italy, provided that they fulfil all of the eligibility criteria listed below