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New hope for Hard-to-Treat seizures: cenobamate under study

NCT ID NCT07474285

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the drug cenobamate can help reduce seizures in adults with autoimmune epilepsy, a condition where the immune system attacks the brain. Researchers will track 30 participants for 24 weeks to see if seizure frequency drops by at least half. The goal is to find a better treatment option for people whose seizures persist despite standard therapies.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population will include adult patients (\>18 years) who provide written informed consent and have a diagnosis of autoimmune epilepsy according to the ILAE 2017 criteria. Eligible participants must have been on a stable treatment regimen with immunotherapy and antiseizure medications (ASMs) for at least 3 months prior to initiating cenobamate (CNB). Patients will be excluded if they have a familial short QT syndrome, known hypersensitivity to CNB or any excipients, or a history of severe adverse drug reactions, including DRESS or Stevens-Johnson syndrome. Additional exclusion criteria include inability to read and write in Italian, as well as pregnancy or breastfeeding.

Ages

18 years and older

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. * Signed informed consent. * Diagnosis of autoimmune epilepsy according to the ILAE 2017 criteria. * Stable treatment regimen with immunotherapy and antiseizure medications (ASMs) during the 3 months preceding the initiation of CNB treatment. Exclusion Criteria: * Diagnosis of familial short QT syndrome. * Hypersensitivity to CNB or any of its excipients. * History of severe adverse drug reactions, including DRESS and Stevens-Johnson syndrome. * Inability to read and write in Italian. * Pregnant or breastfeeding patients

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Conditions

The condition(s) this trial relates to.

autoimmune epilepsy epilepsy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autoimmune epilepsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UOC di Neurologia

    Rome, Lazio, 00168, Italy