New hope for epilepsy: Real-World data on Cenobamate's impact
NCT ID NCT05859854
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This study looks at how well the drug cenobamate works for adults with focal seizures that don't improve with at least two other epilepsy medicines. Researchers are collecting data from Italian clinics and a compassionate use program to measure seizure reduction and side effects. About 936 participants are being followed to see if cenobamate can safely lower seizure frequency in real-world settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cenobamate
- What this could lead to
- If successful, this study could confirm that cenobamate helps reduce seizure frequency in adults with hard-to-control focal epilepsy.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be less reliable. It also focuses on real-world use, not a new treatment discovery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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936 people
The number who actually took part.
- Started
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Jan 2023
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
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18 to 99 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Associazione La Nostra Famiglia - IRCCS Eugenio Medea
Conegliano, Treviso, 31015, Italy
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Azienda Sanitaria Universitaria (A.O.U.) Integrata
Udine, Udine, 33100, Italy
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Campus Bio-Medico
Roma, Roma, 00128, Italy
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Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Pavia, 27100, Italy
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Humanitas Gradenigo
Torino, Torino, 10153, Italy
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IRCCS Neuromed
Pozzilli, Isernia, 86077, Italy
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Ospedale San Bortolo
Vicenza, Vicenza, 36100, Italy
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Policlinico Umberto I
Roma, Roma, 00161, Italy
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Policlinico di Bari
Bari, Bari, 70124, Italy
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Università degli Studi di Catanzaro "Magna Graecia"
Catanzaro, Catanzaro, 88100, Italy
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