New drug cenobamate tested in real life for stubborn seizures
NCT ID NCT06716801
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is tracking 300 adults with focal epilepsy whose seizures are not well controlled despite trying 2-3 other medications. Researchers are observing how well cenobamate works when added to their current treatment in real-world clinics across France, Germany, and Spain. The main goal is to see how many patients have at least a 50% reduction in seizures after 6 and 12 months of treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cenobamate (a drug to reduce seizures)
- What this could lead to
- If successful, this study could show that cenobamate helps more people with hard-to-control focal seizures achieve better seizure control in everyday clinical practice.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by other factors. It is also relatively small (300 participants) and early in real-world use, so findings may not apply to everyone.
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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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Mar 2027
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 affected by epilepsy with focal-onset seizures with or without secondary generalization who have not been adequately controlled despite a history of treatment with 2 or 3 anti-seizure medications (ASMs).
- Ages
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18 years and older
- 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: 1. Male and female patients ≥18 years old at the time of cenobamate treatment initiation. 2. Patients with a diagnosis of epilepsy with focal-onset seizures, with or without secondary generalization. 3. Patients under titration phase (i.e., maintenance dose not reached yet according to clinical judgement) with cenobamate as adjunctive therapy in third or fourth line with 1 to maximum 2 (for third line)/3 (for fourth line) concomitant anti-seizure medications (ASMs). 4. Patients who have not been adequately controlled despite treatment with 2 or 3 (maximum) ASMs before cenobamate treatment initiation (including concomitant ASMs started before initiating cenobamate). 5. Patients with available retrospective data in medical charts, seizure diaries or patient's notes, including reliable information about seizure frequency (intended as the number of seizures and the corresponding time period) in the last 3 months before cenobamate treatment initiation. 6. Written informed consent (including consent for the processing of personal data) signed by the patient, or by the legally designated representative in case of patient lacking capacity, prior to entering the study following local regulation. Exclusion Criteria: 1. Patients who meet any of the contraindications to the administration of cenobamate according to its approved Summary of Product Characteristics (SmPC). 2. Patients with progressive neurodegenerative central nervous system (CNS) diseases or (benign or malignant) brain tumors. 3. Patients with unstable psychiatric diagnosis, including suicidal ideation and behavior within 6 months prior to enrolment, current psychotic disorder, or acute mania. 4. Patients with known substance abuse or dependence (except for caffeine and nicotine). 5. Patients participating in any interventional study from cenobamate treatment initiation until enrolment visit. 6. Patients with ongoing pregnancy or breast-feeding from cenobamate treatment initiation until enrolment visit. 7. Patients who are seizure-free in the last 3 months before cenobamate treatment initiation.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Hôpital TARNIER COCHIN
RECRUITINGParis, France, France
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