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New study checks if seizure drug cuts hospital trips

NCT ID NCT06922175

Knowledge-focused Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 back at medical records of 200 adults with uncontrolled focal seizures to see if adding cenobamate to their treatment reduces hospital stays, ER visits, and doctor appointments. Researchers will compare healthcare use before and after starting cenobamate. The goal is to understand if this drug helps lower the burden on patients and the healthcare system.

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 200 people

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

Started

Dec 2024

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 affected by epilepsy with focal-onset seizures not adequately controlled after 2 or more anti-seizure medications (ASMs), due to efficacy or tolerability issues, who start a treatment with cenobamate as an adjunctive therapy (according to SmPC), in real world setting, and have at least 6 months of data on treatment and healthcare resources utilization (HCRU) (if any) prior to cenobamate starting date.

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: 1. Male and female patients of any ethnic origin ≥18 years old at index date; 2. Patients with a diagnosis of epilepsy with uncontrolled focal-onset seizures despite the previous treatment with from 2 to 5 ASMs who started treatment with cenobamate at index date; 3. Patients presenting at least 1 seizure a month in the last 6 months prior to index date; 4. Patients with at least 6 months of data coverage in the medical records prior to the index date; 5. Patients with at least 12 months of data in the medical records after index date (with a maximum interval between data of 6 months). 6. Patients who give the consent to the processing of personal data according to the General Data Protection Regulation (GDPR) and/or other applicable local regulation. Exclusion Criteria: 1. Patients who meet any of the contraindications to the administration of adjunctive ASMs according to their approved SmPC; 2. Patients who started cenobamate within an EAP; 3. Progressive neurological disease, including degenerative CNS diseases and/or progressive brain tumors; 4. Patients with specific syndrome (e.g. LGS and Dravet); 5. Pregnancy or lactation; 6. Patients without self-judgement ability; 7. Patients with substance and alcohol abuse or dependence (except for caffeine and nicotine); 8. Patients participating in any pharmacological or nonpharmacological interventional study starting from 6 months before the index date.

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Conditions

The condition(s) this trial relates to.

epilepsy focal epilepsy

As listed by the trial registrant

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

Epilepsy with uncontrolled focal-onset seizures

How to take part

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

  1. The places running it

    10 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Consorcio Hosp. General Universitario Valencia

    RECRUITING

    Valencia, Spain, Spain

  • Department of Neurology, University Hospital Zurich

    RECRUITING

    Zurich, Switzerland, Switzerland

  • Diakonie Kork, Epilepsiezentrum

    NOT_YET_RECRUITING

    Kork, Germany, Germany

  • Epilepsies - The Royal Wolverhampton NHS Trust

    RECRUITING

    Wolverhampton, UK, United Kingdom

  • Epilepsiezentrums am Neurozentrum des Universitätsklinikum Freiburg

    NOT_YET_RECRUITING

    Freiburg im Breisgau, Germany, Germany

  • Epilepsy Unit - Neurology Department Valle de Hebron Hospital

    RECRUITING

    Barcelona, Spain, Spain

  • Epilepsy Unit of the Neurology Department of the Hospital Clínico San Carlos

    RECRUITING

    Madrid, Spain, Spain

  • Epileptologicum

    NOT_YET_RECRUITING

    Hamburg, Germany, Germany

  • Institute of Neurosciences NHS Greater Glasgow and Clyde

    RECRUITING

    Glasgow, UK, United Kingdom

  • Kempenhaeghe - Academisch Centrum voor Epilepsie

    NOT_YET_RECRUITING

    Heeze, Netherlands, Netherlands