An observational study in Epilepsy, Focal-Onset Seizure and Neurological Disorder, sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A. Active, not recruiting at 10 sites in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2025-09-08.
Sponsored by Aziende Chimiche Riunite Angelini Francesco S.p.A · Observational
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.
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.
1,848 studies on the registry are indexed under Epilepsy; 422 are open to participants now.
This study's enrollment of 936 is above the median of 112 across 540 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Aziende Chimiche Riunite Angelini Francesco S.p.A is the lead sponsor of 40 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure frequency (overall)
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").
Time frame: 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)
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").
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation
Intra-patient percent change in the seizure frequency (overall)
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.
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure (stratified)
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).
Time frame: 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)
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).
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation
Intra-patient percent change in the seizure frequency (stratified)
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).
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation
Absolute frequency of patients achieving a ≥50%/≥75%/≥90%/=100% sustained reduction in the seizure frequency
Sustained seizure frequency reduction will be defined as a ≥50%/≥75%/≥90%/=100% reduction in baseline seizure frequency achieved at 12 weeks of cenobamate treatment initiation, that continues (is sustained) without interruption and without cenobamate permanent discontinuation through the observation period until 24 and 52 weeks of cenobamate treatment initiation, respectively.
Time frame: 24 and 52 weeks of cenobamate treatment initiation.
Absolute frequency of patients achieving a ≥75%/≥90%/=100% reduction in the seizure frequency
Seizure frequency reduction will be defined as a ≥75%/≥90%/=100% reduction in baseline seizure frequency achieved at 12, 24 and 52 weeks of cenobamate treatment initiation, respectively.
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation.
Relative frequencies of patients achieving a ≥50%/≥75%/≥90%/=100% sustained reduction in the seizure frequency
Sustained seizure frequency reduction will be defined as a ≥50%/≥75%/≥90%/=100% reduction in baseline seizure frequency achieved at 12 weeks of cenobamate treatment initiation, that continues (is sustained) without interruption and without cenobamate permanent discontinuation through the observation period until 24 and 52 weeks of cenobamate treatment initiation, respectively
Time frame: 24 and 52 weeks of cenobamate treatment initiation.
Relative frequencies of patients achieving a ≥75%/≥90%/=100% reduction in the seizure frequency
Seizure frequency reduction will be defined as a ≥75%/≥90%/=100% reduction in baseline seizure frequency achieved at 12, 24 and 52 weeks of cenobamate treatment initiation.
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation.
Absolute frequency of patients with at least one AE
Absolute frequency of patients treated with cenobamate who experienced at least one AE during the applicable observation period
Time frame: Through study completion, an average of 1 year
Relative frequency of patients with at least one AE
Relative frequency of patients treated with cenobamate who experienced at least one AE during the applicable observation period
Time frame: Through study completion, an average of 1 year
Absolute frequency of patients with at least one ADR
Absolute frequency of patients treated with cenobamate who experienced at least one ADR during the applicable observation period
Time frame: Through study completion, an average of 1 year
Relative frequency of patients with at least one ADR
Relative frequency of patients treated with cenobamate who experienced at least one ADR during the applicable observation period
Time frame: Through study completion, an average of 1 year
Absolute frequency of patients treated with at least one SAE
Absolute frequency of patients treated with at least one SAE during the applicable observation period
Time frame: Through study completion, an average of 1 year
Relative frequency of patients treated with at least one SAE
Relative frequency of patients treated with at least one SAE during the applicable observation period
Time frame: Through study completion, an average of 1 year
Health-Related Quality of life (HRQoL)
The Health-Related Quality of life (HRQoL) of patients will be assessed by means of the 31-item Quality Of Life In Epilepsy inventory (QOLIE-31). The 31-item Quality Of Life In Epilepsy inventory (QOLIE-31) is a patient self-reported instrument that contains 31 items grouped in seven multi-item scales ( "seizure worry", "overall QoL", "emotional well-being", "energy fatigue", "cognitive functioning", "medication effects" and "social functioning"). Different items in the QOLIE-31 have different ranges of precoded numeric values, so the scoring procedure requires conversion from raw, precoded numeric values to scores of 0-100 points, with higher scores reflecting better quality of life. The QOLIE-31 overall score is calculated by summing the product of each scale score times its weight and summing over all scales, according to the instructions obtained from copyright holders.
Time frame: 12, 24 and 52 weeks
Patient Global functioning (CGI-S)
The patient global functioning will be assessed by means of the Clinical Global Impression (CGI) Scales. The Early Clinical Drug Evaluation Program (ECDEU) version of the CGI is a 3-item clinician rated scale that measures illness severity (CGI-S), global improvement or change (CGI-I) and treatment response (efficacy index: CGI-E). The CGI-S score ranges from 1 (normal) through to 7 (amongst the most severely ill patients). The calculation of the scores will be performed according to the instructions obtained from copyright holders.
Time frame: 12, 24 and 52 weeks
Patient Global functioning (CGI-I)
The patient global functioning will be assessed by means of the Clinical Global Impression (CGI) Scales. The Early Clinical Drug Evaluation Program (ECDEU) version of the CGI is a 3-item clinician rated scale that measures illness severity (CGI-S), global improvement or change (CGI-I) and treatment response (efficacy index: CGI-E). The CGI-I score ranges from 1 (very much improved) through to 7 (very much worse). The calculation of the scores will be performed according to the instructions obtained from copyright holders.
Time frame: 12, 24 and 52 weeks
Patient Global functioning (CGI-E)
The patient global functioning will be assessed by means of the Clinical Global Impression (CGI) Scales. The Early Clinical Drug Evaluation Program (ECDEU) version of the CGI is a 3-item clinician rated scale that measures illness severity (CGI-S), global improvement or change (CGI-I) and treatment response (efficacy index: CGI-E). The CGI-E score should take account of both therapeutic effect and tolerance, and ranges from 0 (marked improvement and no toxicity) and 4 (unchanged or worse and toxicity outweigh the therapeutic effects). Each component of the CGI is rated separately; the instrument does not yield a global score. The calculation of the scores will be performed according to the instructions obtained from copyright holders.
Time frame: 12, 24 and 52 weeks
Daytime Sleepiness
Daytime Sleepiness will be assessed by means of the Epworth Sleepiness Scale (ESS). The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different daily activities. The ESS score can range from 0 to 24. The higher the ESS score, the higher that person Average Sleep Propensity in Daily Life (ASP), or their daytime sleepiness across a wide range of activities in their daily lives.
Time frame: 12, 24 and 52 weeks
Hospital Anxiety and Depression
Anxiety and depression symptoms will be assessed by means of the the Hospital Anxiety and Depression Scale (HADS). This is a patient self-reported instrument consisting of 14 items that provide scores on two specific subscales: "Anxiety" subscale (HADS-A, 7 items) and "Depression" subscale (HADS-D, 7 items). All items were scored on a 4-point Likert scale from 0 ("never") to 3 ("almost every day") referring to overt symptoms within the last week. Total scores range from 0 to 21 points for each subscale, with higher scores indicating higher levels of symptoms.
Time frame: 12, 24 and 52 weeks
Retention with cenobamate
Retention with cenobamate will be assessed by calculating the frequency of patients still on treatment with cenobamate at 52 weeks of treatment initiation.
Time frame: 52 weeks
Started Jan 2023 (actual). Primary completion is estimated for Dec 2025, 35 months after the start.
Of 37 industry-sponsored observational studies under Epilepsy, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 59. This study's planned 35 months is close to that.
Counting every sponsor, half of 230 studies reached it within 59 months; a quarter within 24 and three quarters within 119.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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