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New pill could tame focal seizures when other drugs fail

NCT ID NCT05716100

Disease control Sponsor: Xenon Pharmaceuticals Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether XEN1101 (azetukalner) can safely reduce seizure frequency in people with focal-onset seizures. About 360 adults whose seizures aren't controlled by current medications will receive either XEN1101 or a placebo added to their existing treatment. The study is double-blind, so neither participants nor doctors know who gets the real drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XEN1101 (azetukalner)
What this could lead to
If successful, XEN1101 could become a new add-on treatment option for people with focal seizures who haven't found relief from existing medications.
What could go wrong
This is a Phase 3 trial, but results from earlier phases may not hold up. The drug may cause side effects or fail to show meaningful seizure reduction compared to placebo.
Why investors are watching

Xenon Pharmaceuticals is testing XEN1101, an add-on seizure drug, in a late-stage Phase 3 trial with 360 participants who have focal-onset seizures. For a small company, this readout is a major event because a positive result could support a regulatory approval application, while a negative result would set the program back significantly.

If it works: If the trial shows XEN1101 reduces seizures better than placebo with acceptable safety, Xenon could move toward seeking approval to sell the drug. That would give the company a commercial product and a potential revenue source.

If it fails: Phase 3 trials often fail, and a negative or unclear result would likely force Xenon to abandon or redesign the program, hurting its prospects. Delays in completing the trial would also push back any potential approval and keep the company dependent on its pipeline.

AI-written from the trial record. Speculative, and not investment advice.

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.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 360 people

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

Started

May 2023

Expected to finish

Dec 2026

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.

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: * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study * Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom. * Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration of the DBP * Able to keep accurate seizure diaries Exclusion Criteria: * Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures. * History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome. * Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive central nervous system (CNS) disease. * History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted. * History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment. * Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol.

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Conditions

The condition(s) this trial relates to.

epilepsy focal epilepsy visual epilepsy

As listed by the trial registrant

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

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

    59 sites in 14 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

  • 9D University Health Center

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Alfred Hospital

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 30004, Australia

  • Austin Epilepsy Care Center

    RECRUITING

    Austin, Texas, 78758, United States

  • Austin Health

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, 3084, Australia

  • Axis Heilsa S. de R.L. de C.V. Althian

    ACTIVE_NOT_RECRUITING

    Monterrey, Mexico

  • CENyR Centro de Especialidades Neurologicas y Rehabilitacion

    ACTIVE_NOT_RECRUITING

    C.a.b.a., C1424, Argentina

  • CINSAN

    WITHDRAWN

    Santiago, 8431657, Chile

  • COPERNICUS Podmiot Leczniczy

    RECRUITING

    Gdansk, Poland

  • Centre Hospitalier Universitaire de Lille (CHU de Lille)

    RECRUITING

    Lille, 59037, France

  • Centro Hospitalar Lisboa Ocidental

    RECRUITING

    Lisbon, Portugal

  • Centro Hospitalar Universitário de Coimbra - CHUC

    RECRUITING

    Coimbra, Portugal

  • Centro Hospitalar Universitário de Santo António

    RECRUITING

    Porto, 4099-001, Portugal

  • Centro Hospitalar de Entre o Douro e Vouga

    RECRUITING

    Santa Maria da Feira, 520-211, Portugal

  • Centro Hospitalar de Lisboa Norte

    RECRUITING

    Lisbon, 1649-035, Portugal

  • Centro de Investigacion Clinica UC

    ACTIVE_NOT_RECRUITING

    Santiago, 833073, Chile

  • Chu de Rennes Hôpital Pontchaillou

    RECRUITING

    Rennes, 35033, France

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Universidad de Los Andes

    WITHDRAWN

    Santiago, 7620157, Chile

  • Clinical Hospital Center Rijeka, Klinika za Neurologiju

    WITHDRAWN

    Rijeka, 51000, Croatia

  • Clinical Trials, Inc.

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Cliniques Universitaires Saint-Luc (UCL)

    RECRUITING

    Brussels, 1200, Belgium

  • Consultants in Epilepsy and Neurology, PLLC

    RECRUITING

    Boise, Idaho, 83702, United States

  • Duke University Clinic

    RECRUITING

    Durham, North Carolina, 27705, United States

  • EUC Hradec Kralove Clinic

    WITHDRAWN

    Hradec Králové, Czechia

  • FLENI

    ACTIVE_NOT_RECRUITING

    C.a.b.a., C1428DGG, Argentina

  • Five Towns Neuroscience Research

    WITHDRAWN

    Woodmere, New York, 11598, United States

  • Forbeli s.r.o.

    RECRUITING

    Prague, Czechia

  • Grupo Medico Camino

    ACTIVE_NOT_RECRUITING

    Benito Juárez, Mexico

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hopital Neurologique Pierre Wertheimer

    RECRUITING

    Bron, 69500, France

  • Hospital Britanico de Buenos Aires

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1280AEB, Argentina

  • Hospital Central Ramon Carrilo

    ACTIVE_NOT_RECRUITING

    San Luis, 5701, Argentina

  • Hospital Clínico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Clínico Viña del Mar

    ACTIVE_NOT_RECRUITING

    Viña del Mar, Chile

  • Hospital Córdoba

    ACTIVE_NOT_RECRUITING

    Córdoba, X5000, Argentina

  • Hospital De Alta Complejidad en Red el Cruce

    ACTIVE_NOT_RECRUITING

    Buenos Aires, 1888, Argentina

  • Hospital Italiano

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1199ABB, Argentina

  • Hospital Pedro Hispano

    RECRUITING

    Porto, 4464-513, Portugal

  • Hospital Ramos Mejia

    ACTIVE_NOT_RECRUITING

    Buenos Aires, 1221, Argentina

  • Hospital Universitario Cruces

    RECRUITING

    Barakaldo, 48903, Spain

  • Hospital Unversitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital da Senhora da Oliveira

    RECRUITING

    Guimarães, 4835-044, Portugal

  • Hospital universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Human Science Research Trials

    ACTIVE_NOT_RECRUITING

    Mexico City, 14050, Mexico

  • Hôpital Fondation A. de Rothschild

    RECRUITING

    Paris, 75019, France

  • Hôpital de Hautepierre

    RECRUITING

    Strasbourg, 67098, France

  • Hôpital de la Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Instituto de Neurologia Cognitiva (INECO)

    ACTIVE_NOT_RECRUITING

    Buenos Aires, C1060AAF, Argentina

  • Kaplan Medical Center

    RECRUITING

    Rehovot, 76100, Israel

  • Kempenhaeghe

    RECRUITING

    Heeze, Netherlands

  • Krankenhaus Mara gGmbH

    RECRUITING

    Bielefeld, 33617, Germany

  • Kuopio University Hospital

    RECRUITING

    Kuopio, 70210, Finland

  • MHATNPsy Sveti Naum EAD

    ACTIVE_NOT_RECRUITING

    Sofia, 1113, Bulgaria

  • MTZ Clinical Research Powered by Pratia

    RECRUITING

    Warsaw, 02-172, Poland

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical University of Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Medical center OPHTHA-NEURO

    WITHDRAWN

    Sofia, 1172, Bulgaria

  • Mid-Atlantic Epilepsy and Sleep Center

    RECRUITING

    Bethesda, Maryland, 20817, United States

  • NZOZ Neuromed M. i M. Nastaj Sp. P.

    WITHDRAWN

    Lublin, 20-064, Poland

  • Nemocnicni lekarna FN Motol / Motol University Hospital

    RECRUITING

    Prague, 150 06, Czechia

  • Neurocencias Esudios Clinicos S.C.

    ACTIVE_NOT_RECRUITING

    Sinaloa, 80020, Mexico

  • Neurosphera Sp. z o.o.

    RECRUITING

    Warsaw, 02-829, Poland

  • Northeast Regional Epilepsy Group

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • OhioHealth

    RECRUITING

    Columbus, Ohio, 43214, United States

  • Ospedali Riuniti di Ancona

    WITHDRAWN

    Ancona, 60126, Italy

  • Panhandle Research and Medical Clinic

    RECRUITING

    Gulf Breeze, Florida, 32651, United States

  • Policlinico Lomas

    ACTIVE_NOT_RECRUITING

    Buenos Aires, B1832BQD, Argentina

  • Poliklinika Bonifarm

    RECRUITING

    Zagreb, 10000, Croatia

  • Poliklinika LF MEDICAL

    RECRUITING

    Zagreb, 1000, Croatia

  • Prince of Wales Hospital

    ACTIVE_NOT_RECRUITING

    Randwick, New South Wales, 2031, Australia

  • Providence Neurological Specialities

    RECRUITING

    Portland, Oregon, 97225, United States

  • Rancho Research Institute

    RECRUITING

    Downey, California, 90242, United States

  • Royal Melbourne Hospital

    ACTIVE_NOT_RECRUITING

    Melbourne, 3050, Australia

  • Royal Prince Alfred Hospital

    ACTIVE_NOT_RECRUITING

    Camperdown, New South Wales, 2050, Australia

  • STAT Resarch S.A.

    ACTIVE_NOT_RECRUITING

    Buenos Aires, Argentina

  • Sanatori del Sur S.A.

    ACTIVE_NOT_RECRUITING

    San Miguel de Tucumán, Argentina

  • Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika

    ACTIVE_NOT_RECRUITING

    Budapest, 1145, Hungary

  • Southern Illinois University School of Medicine

    RECRUITING

    Springfield, Illinois, 62794, United States

  • The Chaim Sheba Medical Center

    RECRUITING

    Ramat Gan, 6265601, Israel

  • The Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 64239, Israel

  • Twoja Przychodnia Nowosolskie Centrum Medyczne

    RECRUITING

    Nowa Sól, 67-100, Poland

  • ULS de Trás-os-Montes e Alto Douro

    RECRUITING

    Vila Real, 5000-508, Portugal

  • Universitair Ziekenhuis Gent

    RECRUITING

    Ghent, 9000, Belgium

  • University Hospital Center Osijek

    WITHDRAWN

    Osijek, 31000, Croatia

  • University Hospital Center Zagreb

    RECRUITING

    Zagreb, 10000, Croatia

  • University Hospital Frankfurt, ZNN - Epilepsy Center Frankfurt Rhine-Main

    RECRUITING

    Frankfurt, 60528, Germany

  • University Hospital Innsbruck

    RECRUITING

    Innsbruck, Austria

  • University of California Irvine Health

    RECRUITING

    Orange, California, 92868, United States

  • University of California Los Angeles (UCLA)

    RECRUITING

    Los Angeles, California, 90095, United States

  • University of Utah Clinical Neurosciences Center

    ACTIVE_NOT_RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Università degli studi di Bari Aldo Moro

    RECRUITING

    Bari, 70124, Italy

  • Universitätsklinik für Neurologie

    RECRUITING

    Salzburg, 5020, Austria

  • Universitätsklinikum Aachen

    RECRUITING

    Aachen, D-52074, Germany

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Westmead Hospital

    ACTIVE_NOT_RECRUITING

    Westmead, New South Wales, 2145, Australia

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