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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure frequency (overall) — 12, 24 and 52 weeks of cenobamate treatment initiation Seizure frequency during the baseline and post-baseline assessments was calculated by summing the total number of seizures (all types of seizures) reported in each considered period and dividing by the duration of that period (number of days), excluding days with no available diary data, and multiplying by 28 to normalize to a monthly rate ("monthly seizure frequency").
Relative frequency of patients achieving a ≥50% (50% or greater) reduction in the seizure frequency (overall) — 12, 24 and 52 weeks of cenobamate treatment initiation Seizure frequency during the baseline and post-baseline assessments was calculated by summing the total number of seizures (all types of seizures) reported in each considered period and dividing by the duration of that period (number of days), excluding days with no available diary data, and multiplying by 28 to normalize to a monthly rate ("monthly seizure frequency").
Intra-patient percent change in the seizure frequency (overall) — 12, 24 and 52 weeks of cenobamate treatment initiation Intra-patient percent change from baseline will be defined as \[(monthly seizure frequency at post-baseline assessments - monthly seizure frequency at baseline), divided by the monthly seizure frequency at baseline\] multiplied by 100.
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure (stratified) — 12, 24 and 52 weeks of cenobamate treatment initiation Seizure frequency during the baseline and post-baseline assessments was calculated by summing the total number of seizures (all types of seizures) reported in each considered period and dividing by the duration of that period (number of days), excluding days with no available diary data, and multiplying by 28 to normalize to a monthly rate ("monthly seizure frequency").
Population will be stratified according to the following:
* Age class of patient at the time of cenobamate treatment initiation (i.e., \<65 years; ≥65 years).
* Setting of cenobamate treatment initiation (i.e., CUP; current clinical practice).
* Cenobamate final target daily dose prescribed (i.e., 200 mg; \>200 mg).
* Number of ASMs concomitant with cenobamate (i.e., ≤2 ASMs; \>2 ASMs).
Relative frequency of patients achieving a ≥50% (50% or greater) reduction in the seizure frequency (stratified) — 12, 24 and 52 weeks of cenobamate treatment initiation Seizure frequency during the baseline and post-baseline assessments was calculated by summing the total number of seizures (all types of seizures) reported in each considered period and dividing by the duration of that period (number of days), excluding days with no available diary data, and multiplying by 28 to normalize to a monthly rate ("monthly seizure frequency").
Population will be stratified according to the following:
* Age class of patient at the time of cenobamate treatment initiation (i.e., \<65 years; ≥65 years).
* Setting of cenobamate treatment initiation (i.e., CUP; current clinical practice).
* Cenobamate final target daily dose prescribed (i.e., 200 mg; \>200 mg).
* Number of ASMs concomitant with cenobamate (i.e., ≤2 ASMs; \>2 ASMs).
Intra-patient percent change in the seizure frequency (stratified) — 12, 24 and 52 weeks of cenobamate treatment initiation Intra-patient percent change from baseline will be defined as \[(monthly seizure frequency at post-baseline assessments - monthly seizure frequency at baseline), divided by the monthly seizure frequency at baseline\] multiplied by 100.
Population will be stratified according to the following:
* Age class of patient at the time of cenobamate treatment initiation (i.e., \<65 years; ≥65 years).
* Setting of cenobamate treatment initiation (i.e., CUP; current clinical practice).
* Cenobamate final target daily dose prescribed (i.e., 200 mg; \>200 mg).
* Number of ASMs concomitant with cenobamate (i.e., ≤2 ASMs; \>2 ASMs).
Trial sites (10)
Facility
City
Region
Status
Policlinico di Bari
Bari
Bari
Università degli Studi di Catanzaro "Magna Graecia"
Catanzaro
Catanzaro
IRCCS Neuromed
Pozzilli
Isernia
Fondazione Istituto Neurologico Casimiro Mondino
Pavia
Pavia
Campus Bio-Medico
Roma
Roma
Policlinico Umberto I
Roma
Roma
Humanitas Gradenigo
Torino
Torino
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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