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NCT05859854Active, not recruiting

Cenobamate in Adults With Focal-Onset Seizures

Cenobamate in Adults With Focal-Onset Seizures: a Real-World Multicenter Observational Italian

Source: ClinicalTrials.gov · Last updated 8 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
936 (actual)
First submitted
26 Apr 2023
Start date
24 Jan 2023
Primary completion date
Dec 2025
Lead sponsor
Aziende Chimiche Riunite Angelini Francesco S.p.A
Diseases
Epilepsy
NCT number
NCT05859854

What you commit to

  • Study type: Observational
  • Participants enrolled: 936
  • From 24 Jan 2023 to the primary completion date, Dec 2025
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Lab values

  • Patients diagnosed with familial short-QT syndrome

Other

  • 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.

Who the study is looking for

  • 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-

Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico di Bari
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BariItalyUnknown status
Università degli Studi di Catanzaro "Magna Graecia"
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CatanzaroItalyUnknown status
Associazione La Nostra Famiglia - IRCCS Eugenio Medea
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ConeglianoItalyUnknown status
Fondazione Istituto Neurologico Casimiro Mondino
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PaviaItalyUnknown status
IRCCS Neuromed
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PozzilliItalyUnknown status
Campus Bio-Medico
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RomaItalyUnknown status
Policlinico Umberto I
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RomaItalyUnknown status
Humanitas Gradenigo
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TorinoItalyUnknown status
Azienda Sanitaria Universitaria (A.O.U.) Integrata
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UdineItalyUnknown status
Ospedale San Bortolo
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VicenzaItalyUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.