EpilepsyBLESSNCT05859854
Cenobamate in Adults With Focal-Onset Seizures
An observational study of Epilepsy and Focal-Onset Seizure, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 10 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Epilepsy, Focal-Onset Seizure, Neurological Disorder
- How many people
- 936 participants
- Where
- 10 sitesItaly
- Study dates
- 24 Jan 2023to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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-
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Italy10 sites
Policlinico di Bari
Bari, Bari, 70124
Università degli Studi di Catanzaro "Magna Graecia"
Catanzaro, Catanzaro, 88100
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Conegliano, Treviso, 31015
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Pavia, 27100
IRCCS Neuromed
Pozzilli, Isernia, 86077
Campus Bio-Medico
Roma, Roma, 00128
Policlinico Umberto I
Roma, Roma, 00161
Humanitas Gradenigo
Torino, Torino, 10153
Azienda Sanitaria Universitaria (A.O.U.) Integrata
Udine, Udine, 33100
Ospedale San Bortolo
Vicenza, Vicenza, 36100
About this study
Official title: Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian
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.
Read the detailed 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.
- Conditions
- Epilepsy, Focal-Onset Seizure, Neurological Disorder
- Keywords
- cenobamate, Real-word, epilepsy, focal-onset seizure, observational, focal epilepsy uncontrolled
- Medical subject headings
- Epilepsy, Seizures, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients diagnosed treated with adjunctive cenobamate in Italy. | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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").
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12, 24 and 52 weeks of cenobamate treatment initiation
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start24 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859854
- Sponsor's protocol ID
- 153(A)IM21348
- Acronym
- BLESS
- Status last verified
- May 2025
- First submitted
- 26 Apr 2023
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lattanzi S, d'Orsi G, Di Claudio MT, D'Aniello A, Sensi SL, Dono F, Panebianco M, Sicurella L, Di Liberto A, Novara A, Di Bonaventura C, Bonanni P, Liguori C, Ranzato F, Gambardella A, Bisulli F, Pulitano P, Pauletto G, Tartara E, Vatti G, Assenza G, Giordano A, Vaudano AE, Mazza G, La Neve A, Pignatta P, Beretta S, Pezzella M, Cecconi M, Pizzanelli C, Andreone V, Vollono C, Puligheddu M, Gangitano M, Audenino D, Foschi N, Fallica E, Boero G, Stokelj D, Pasolini MP, Tramacere L, Strigaro G, Ferlazzo E, Zanoni T, Penza P, Elia M, Quadri S, De Maria G, Santo Sabato M, Giuliano L, Galli R, Labate A, Dainese F, Falcicchio G, De Simone R, Procaccini M, Villano V, Camattari G, Andreis D, Simoni L, Di Gennaro G; BLESS Study Group. Beyond seizure control: Non-seizure-related outcomes in focal-onset epilepsy treated with adjunctive cenobamate. Third interim results from the BLESS study. Epilepsia. 2026 Oct 15. doi: 10.1002/epi.70501. Online ahead of print.
PubMed 42879242Lattanzi S, Ranzato F, Di Bonaventura C, Bonanni P, Gambardella A, Tartara E, Assenza G, Procaccini M, Falsetto N, Villano V, Camattari G, Ori A, Di Gennaro G; BLESS Study Group. Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study. Neurol Ther. 2024 Aug;13(4):1203-1217. doi: 10.1007/s40120-024-00634-5. Epub 2024 Jun 8.
PubMed 38850402
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian
- ClinicalTrials.gov ID
- NCT05859854
- Acronym / sponsor ID
- BLESS / 153(A)IM21348
- Conditions
- Epilepsy, Focal-Onset Seizure, Neurological Disorder
- Keywords
- cenobamate, Real-word, epilepsy, focal-onset seizure, observational, focal epilepsy uncontrolled
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- IQVIA Pty Ltd
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients diagnosed treated with adjunctive cenobamate in Italy. | – | –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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure frequency (overall)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
17 secondary outcomes
Absolute frequency of patients achieving a ≥50%/≥75%/≥90%/=100% sustained reduction in the seizure frequency
Time frame: 24 and 52 weeks of cenobamate treatment initiation.
Absolute frequency of patients achieving a ≥75%/≥90%/=100% reduction in the seizure frequency
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
Time frame: 24 and 52 weeks of cenobamate treatment initiation.
Relative frequencies of patients achieving a ≥75%/≥90%/=100% reduction in the seizure frequency
Time frame: 12, 24 and 52 weeks of cenobamate treatment initiation.
Absolute frequency of patients with at least one AE
Time frame: Through study completion, an average of 1 year
Relative frequency of patients with at least one AE
Time frame: Through study completion, an average of 1 year
Absolute frequency of patients with at least one ADR
Time frame: Through study completion, an average of 1 year
Relative frequency of patients with at least one ADR
Time frame: Through study completion, an average of 1 year
Absolute frequency of patients treated with at least one SAE
Time frame: Through study completion, an average of 1 year
Relative frequency of patients treated with at least one SAE
Time frame: Through study completion, an average of 1 year
Health-Related Quality of life (HRQoL)
Time frame: 12, 24 and 52 weeks
Patient Global functioning (CGI-S)
Time frame: 12, 24 and 52 weeks
Patient Global functioning (CGI-I)
Time frame: 12, 24 and 52 weeks
Patient Global functioning (CGI-E)
Time frame: 12, 24 and 52 weeks
Daytime Sleepiness
Time frame: 12, 24 and 52 weeks
Hospital Anxiety and Depression
Time frame: 12, 24 and 52 weeks
Retention with cenobamate
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Derived from this study: PubMed 42879242Lattanzi S, d'Orsi G, Di Claudio MT, D'Aniello A, Sensi SL, Dono F, Panebianco M, Sicurella L, Di Liberto A, Novara A, Di Bonaventura C, Bonanni P, Liguori C, Ranzato F, Gambardella A, Bisulli F, Pulitano P, Pauletto G, Tartara E, Vatti G, Assenza G, Giordano A, Vaudano AE, Mazza G, La Neve A, Pignatta P, Beretta S, Pezzella M, Cecconi M, Pizzanelli C, Andreone V, Vollono C, Puligheddu M, Gangitano M, Audenino D, Foschi N, Fallica E, Boero G, Stokelj D, Pasolini MP, Tramacere L, Strigaro G, Ferlazzo E, Zanoni T, Penza P, Elia M, Quadri S, De Maria G, Santo Sabato M, Giuliano L, Galli R, Labate A, Dainese F, Falcicchio G, De Simone R, Procaccini M, Villano V, Camattari G, Andreis D, Simoni L, Di Gennaro G; BLESS Study Group. Beyond seizure control: Non-seizure-related outcomes in focal-onset epilepsy treated with adjunctive cenobamate. Third interim results from the BLESS study. Epilepsia. 2026 Oct 15. doi: 10.1002/epi.70501. Online ahead of print.
- Derived from this study: PubMed 38850402Lattanzi S, Ranzato F, Di Bonaventura C, Bonanni P, Gambardella A, Tartara E, Assenza G, Procaccini M, Falsetto N, Villano V, Camattari G, Ori A, Di Gennaro G; BLESS Study Group. Effectiveness and Safety of Adjunctive Cenobamate in People with Focal-Onset Epilepsy: Evidence from the First Interim Analysis of the BLESS Study. Neurol Ther. 2024 Aug;13(4):1203-1217. doi: 10.1007/s40120-024-00634-5. Epub 2024 Jun 8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Focal-Onset Seizure, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 10 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute frequency of patients achieving a 50 % or greater reduction in the seizure frequency (overall) (time frame: 12, 24 and 52 weeks of cenobamate treatment initiation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05859854, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.