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New epilepsy drug shows promise in final stage trial

NCT ID NCT05614063

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested a drug called XEN1101 (azetukalner) in 380 adults with focal-onset seizures that were not well-controlled by other medications. Participants took either XEN1101 or a placebo alongside their usual seizure drugs. The study measured whether XEN1101 reduced monthly seizure frequency more than placebo. Results are not yet available, but if positive, XEN1101 could offer a new option for people with hard-to-treat focal epilepsy.

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 medication to help reduce seizure frequency in people with focal epilepsy who haven't responded well to other drugs.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. Even if effective, XEN1101 is an add-on therapy, not a cure, and may cause side effects or not work for 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.

Phase

Phase 3

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

Participants

380 people

The number who actually took part.

Started

Nov 2022

Finished

Feb 2026

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

Contacts and locations

Locations

  • ANESC Research

    El Paso, Texas, 79912, United States

  • American Hospital Network LLC

    Tbilisi, 0121, Georgia

  • Anschutz Health Sciences

    Aurora, Colorado, 80011, United States

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Austin Epilepsy Care Center (AECC)

    Austin, Texas, 78758, United States

  • Austin Health Pharmacy Clinical Trials

    Heidelberg, Victoria, 3079, Australia

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56100, Italy

  • Azienda Ospedaliero-Universitaria Policlinico Umberto I

    Rome, 00186, Italy

  • Beaumont Hospital

    Dublin, D09 YD60, Ireland

  • Bluegrass Epilepsy Research, LLC

    Lexington, Kentucky, 40504, United States

  • Brain Science Research Institute

    Los Angeles, California, 90025, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • CENyR

    Caba, C1424, Argentina

  • Carilion Clinic - Neurology

    Roanoke, Virginia, 24013, United States

  • Center For Neurologic Research

    Lethbridge, Alberta, T1J 0N9, Canada

  • Centro Hospitalar de Entre o Douro e Vouga

    Santa Maria da Feira, 4520-220, Portugal

  • Centro de investigación Clinica UC

    Santiago, 833073, Chile

  • Centrum Medyczne Neuromed

    Bydgoszcz, 85-163, Poland

  • Clinical Trials, Inc

    Little Rock, Arkansas, 72205, United States

  • Consultants in Epilepsy and Neurology

    Boise, Idaho, 83702, United States

  • Cornwell Health

    Grand Rapids, Michigan, 49506, United States

  • Dent Neurosciences Research Center

    Buffalo, New York, 14226, United States

  • Duke Neurology

    Durham, North Carolina, 27713, United States

  • Emory Brain Health Center

    Atlanta, Georgia, 30329, United States

  • Encore Medical Research of Weston, LLC

    Weston, Florida, 33021, United States

  • Epilepsiezentrum Frankfurt Rhein-Main

    Frankfurt, 60528, Germany

  • Epilepsy Center Bethel

    Bielefeld, 33617, Germany

  • FORBELI s.r.o., Neurologicka ambulance

    Prague, 160-00, Czechia

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817, United States

  • Hospital Clinico San Carlos

    Madrid, 28040, Spain

  • Hospital Clínico Universitario Valladolid

    Valladolid, 47003, Spain

  • Hospital Clínico Vina del Mar

    Viña del Mar, 2520612, Chile

  • Hospital Córdoba

    Córdoba, CP 5000, Argentina

  • Hospital De Alta Complejidad en Red el Cruce Nestor Kirchner - SAMIC

    Buenos Aires, B1888AAE, Argentina

  • Hospital General de Agudos J.M. Ramos Mejia

    Buenos Aires, 1221, Argentina

  • Hospital Italiano

    Buenos Aires, C1199ABB, Argentina

  • Hospital Pedro Hispano

    Porto, 4464-513, Portugal

  • Hospital Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Regional De Malaga

    Málaga, 29010, Spain

  • Hospital Ruber Internacional

    Madrid, 28034, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026, Spain

  • Hospital Vithas La Milagrosa

    Madrid, 28034, Spain

  • Human Science Research Trials S. de R.L. de C.V.

    Mexico City, 14050, Mexico

  • IIS-Fundacion Jimenez Diaz/Farmacia

    Madrid, 28040, Spain

  • INECO and Favoloro Fundation

    Buenos Aires, 1060, Argentina

  • Indiana University, IU Health Partners, Adult Neurology Clinic

    Indianapolis, Indiana, 46202, United States

  • Institute of Neurology and Neuropsychology

    Tbilisi, 0186, Georgia

  • Istituto delle Scienze Neurologiche di Bologna

    Bologna, 40139, Italy

  • John Radcliffe Hospital

    Oxford, OX3 9DU, United Kingdom

  • LMU Munich, Department of Neurology

    Munich, 81277, Germany

  • Le Centre Hospitalier de l'Universite' de Montreal (CHUM)

    Montreal, Quebec, H2X3E4, Canada

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS1 3EX, United Kingdom

  • London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

  • MHAT Puls AD

    Blagoevgrad, 2700, Bulgaria

  • MaineHealth Neurology - Scarborough

    Scarborough, Maine, 04074, United States

  • MedStar Georgetown University Hospital

    Clinton, Maryland, 20735, United States

  • Medsol Clinical Research Center

    Port Charlotte, Florida, 33952, United States

  • Medstar Franklin Square Medical Center

    Baltimore, Maryland, 21237, United States

  • Meridian Clinical Research, LLC

    Raleigh, North Carolina, 27607, United States

  • Michigan State University

    East Lansing, Michigan, 48824, United States

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland, 20817, United States

  • Minneapolis Clinic of Neurology

    Burnsville, Minnesota, 55337, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467-2401, United States

  • Mount Sinai Medical Center

    New York, New York, 10029, United States

  • NYU Comprehensive Epilepsy Center (CEC)

    New York, New York, 10016, United States

  • NZOZ Novo-Med

    Katowice, 40-650, Poland

  • Neurocencias Esudios Clinicos SC

    Sinaloa, 80020, Mexico

  • Neurosphera Sp. z o.o.

    Warsaw, 02-829, Poland

  • Northeast Epilepsy Group

    Hackensack, New Jersey, 07601, United States

  • Northern Care Alliance NHS Foundation Trust, Salford Care Organisation

    Salford, M6 8HD, United Kingdom

  • Onsite Clinical Solutions, LLC

    Charlotte, North Carolina, 28211, United States

  • Panhandle Research & Medical Clinic

    Pensacola, Florida, 32503, United States

  • Pauls Stradina Clinical university hospital

    Riga, LV-1002, Latvia

  • Philipps-Universität Marburg

    Marburg, 35043, Germany

  • Prince of Wales Hospital

    Sydney, New South Wales, 2031, Australia

  • Providence Brain & Spine Institute

    Portland, Oregon, 97225, United States

  • Research Institute of Orlando, LLC

    Orlando, Florida, 32806, United States

  • Riga East University Hospital

    Riga, LV-1024, Latvia

  • Royal London Hospital for Integrated Medicine

    London, WC1N 3HR, United Kingdom

  • Royal Prince Alfred Hospital (RAPH)

    Camperdown, New South Wales, 2050, Australia

  • STAT Research S.A.

    Buenos Aires, C1023AAB, Argentina

  • SUNY Upstate Medical University

    Syracuse, New York, 13210, United States

  • Saint Louis University Medical School - Neurosciences Clinical Research Unit

    St Louis, Missouri, 63104, United States

  • Sanatorio del Sur S.A.

    San Miguel de Tucumán, 4000, Argentina

  • Sentara Neurology Specialists

    Virginia Beach, Virginia, 23456, United States

  • Serenity Research

    Miami, Florida, 33176, United States

  • Southern Neurology

    Sydney, New South Wales, 2217, Australia

  • St Vincent's Hospital Melbourne

    Fitzroy, Melbourne, 3065, Australia

  • St. George's Hospital NHS Foundation Trust

    London, SW17 0QT, United Kingdom

  • Strada Patient Care Center

    Mobile, Alabama, 36604, United States

  • Summa Health

    Akron, Ohio, 44304, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140-4105, United States

  • The Alfred Hospital (Alfred Health)

    Melbourne, Victoria, 3004, Australia

  • The Royal Melbourne Hospital

    Melbourne, 3052, Australia

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • The University of Queensland (UQ) - Mater Research Institute (MRI)

    Brisbane, Queensland, 4101, Australia

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100, Poland

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655, United States

  • UT Health San Antonio

    San Antonio, Texas, 78229, United States

  • UT Physicians Epilepsy Clinic

    Houston, Texas, 77030, United States

  • Unidade Local de Saúde de São João

    Porto, 4200-450, Portugal

  • Unitat d'Assaigs Clínics. Servei de Farmàcia

    Barcelona, 08036, Spain

  • Universitatsklinik fur neurologie, universitats - und Rehabilitationskliniken Ulm

    Ulm, 89081, Germany

  • Universitatsklinikum Bonn

    Bonn, Germany

  • University Hospital of Wales

    Cardiff, CF144XW, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B152GW, United Kingdom

  • University Medical Center Freiburg

    Freiburg im Breisgau, 79106, Germany

  • University of Arizona, Health Sciences Center

    Tucson, Arizona, 85724, United States

  • University of Auckland

    Auckland, 1023, New Zealand

  • University of California, David Clinical & Translational Science Center Clinical Research (CCRC)

    Sacramento, California, 95817, United States

  • University of Kentucky, Dept. of Neurology

    Lexington, Kentucky, 40536-0284, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Washington Main Hospital

    Seattle, Washington, 98104, United States

  • Università Degli Studi Gabriele d'Annunzio Di Chieti

    Pescara, 66100, Italy

  • Universitätsklinikum Tübingen

    Tübingen, 72076, Germany

  • Waikato Hospital

    Hamilton, 3204, New Zealand

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157, United States

  • Washington University, St. Louis

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine/ New York-Presbyterian Hospital

    New York, New York, 10021, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • Xenoscience

    Phoenix, Arizona, 85004, United States

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