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 range18 Years – 99 Years

SexALL

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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…

What they're measuring

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

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

Intra-patient percent change in the seizure frequency (overall)

Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation

Absolute frequency of patients achieving a 50 % or greater reduction in the seizure (stratified)

Timeframe: 12, 24 and 52 weeks of cenobamate treatment initiation

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

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

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Epilepsy trials