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New hope for epilepsy: Real-World data on Cenobamate's impact

NCT ID NCT05859854

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

936 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

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

18 to 99 years

Sex

Anyone

Healthy volunteers

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

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

  • Associazione La Nostra Famiglia - IRCCS Eugenio Medea

    Conegliano, Treviso, 31015, Italy

  • Azienda Sanitaria Universitaria (A.O.U.) Integrata

    Udine, Udine, 33100, Italy

  • Campus Bio-Medico

    Roma, Roma, 00128, Italy

  • Fondazione Istituto Neurologico Casimiro Mondino

    Pavia, Pavia, 27100, Italy

  • Humanitas Gradenigo

    Torino, Torino, 10153, Italy

  • IRCCS Neuromed

    Pozzilli, Isernia, 86077, Italy

  • Ospedale San Bortolo

    Vicenza, Vicenza, 36100, Italy

  • Policlinico Umberto I

    Roma, Roma, 00161, Italy

  • Policlinico di Bari

    Bari, Bari, 70124, Italy

  • Università degli Studi di Catanzaro "Magna Graecia"

    Catanzaro, Catanzaro, 88100, Italy

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