A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

NCT05716100 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: XPF-010-3022022-502281-25-00
• Study Type: interventional
• Target: 360
• Locations: 19 countries
• Sites: 91

Brief Summary

The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.

Conditions

Focal Onset Seizures

Keywords

Epilepsy

Outcome Measures

Primary Outcomes (1)

• Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.

  From baseline through to the double blind period (week 12).

Secondary Outcomes (4)

• Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.

  From baseline through to the double blind period (week 12).

• MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.

  From baseline through to the week 1.

• Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).

  From baseline through to the double blind period (week 12).

• To assess adverse events as criteria for safety and tolerability of XEN1101.

  From screening through to 56 days post-final dose

Study Arms (3)

XEN1101 25 mg/day

EXPERIMENTAL

XEN1101 25 mg/day

Drug: XEN1101

XEN1101 15 mg/day

EXPERIMENTAL

XEN1101 15 mg/day

Drug: XEN1101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

XEN1101 DRUG

XEN1101 Capsules

Also known as: Azetukalner

XEN1101 15 mg/day; XEN1101 25 mg/day

Placebo DRUG

Placebo Capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead
• Worldwide Clinical Trials: collaborator

Study Sites (94)

Clinical Trials, Inc.

Little Rock, Arkansas, 72205, United States

RECRUITING

Rancho Research Institute

Downey, California, 90242, United States

RECRUITING

University of California Los Angeles (UCLA)

Los Angeles, California, 90095, United States

RECRUITING

University of California Irvine Health

Orange, California, 92868, United States

RECRUITING

Panhandle Research and Medical Clinic

Gulf Breeze, Florida, 32651, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, 83702, United States

RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, 62794, United States

RECRUITING

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

RECRUITING

9D University Health Center

Detroit, Michigan, 48201, United States

RECRUITING

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

RECRUITING

Five Towns Neuroscience Research

Woodmere, New York, 11598, United States

WITHDRAWN

Duke University Clinic

Durham, North Carolina, 27705, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

OhioHealth

Columbus, Ohio, 43214, United States

RECRUITING

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

RECRUITING

Austin Epilepsy Care Center

Austin, Texas, 78758, United States

RECRUITING

University of Utah Clinical Neurosciences Center

Salt Lake City, Utah, 84132, United States

RECRUITING

Hospital Ramos Mejia

Buenos Aires, 1221, Argentina

RECRUITING

Hospital De Alta Complejidad en Red el Cruce

Buenos Aires, 1888, Argentina

RECRUITING

Policlinico Lomas

Buenos Aires, B1832BQD, Argentina

RECRUITING

Instituto de Neurologia Cognitiva (INECO)

Buenos Aires, C1060AAF, Argentina

RECRUITING

Hospital Italiano

Buenos Aires, C1199ABB, Argentina

RECRUITING

Hospital Britanico de Buenos Aires

Buenos Aires, C1280AEB, Argentina

RECRUITING

STAT Resarch S.A.

Buenos Aires, Argentina

RECRUITING

CENyR Centro de Especialidades Neurologicas y Rehabilitacion

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

RECRUITING

FLENI

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

RECRUITING

Hospital Córdoba

Córdoba, X5000, Argentina

RECRUITING

Hospital Central Ramon Carrilo

San Luis, 5701, Argentina

RECRUITING

Sanatori del Sur S.A.

San Miguel de Tucumán, Argentina

RECRUITING

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

RECRUITING

Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia

RECRUITING

Westmead Hospital

Westmead, New South Wales, 2145, Australia

RECRUITING

Alfred Hospital

Melbourne, Victoria, 30004, Australia

RECRUITING

Austin Health

Melbourne, Victoria, 3084, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, 3050, Australia

RECRUITING

University Hospital Innsbruck

Innsbruck, Austria

RECRUITING

Universitätsklinik für Neurologie

Salzburg, 5020, Austria

RECRUITING

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

Cliniques Universitaires Saint-Luc (UCL)

Brussels, 1200, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

MHATNPsy Sveti Naum EAD

Sofia, 1113, Bulgaria

RECRUITING

Medical center OPHTHA-NEURO

Sofia, 1172, Bulgaria

RECRUITING

Clinica Universidad de Los Andes

Santiago, 7620157, Chile

WITHDRAWN

Centro de Investigacion Clinica UC

Santiago, 833073, Chile

RECRUITING

CINSAN

Santiago, 8431657, Chile

WITHDRAWN

Hospital Clínico Viña del Mar

Viña del Mar, Chile

RECRUITING

University Hospital Center Osijek

Osijek, 31000, Croatia

WITHDRAWN

Clinical Hospital Center Rijeka, Klinika za Neurologiju

Rijeka, 51000, Croatia

WITHDRAWN

Poliklinika Bonifarm

Zagreb, 10000, Croatia

RECRUITING

University Hospital Center Zagreb

Zagreb, 10000, Croatia

RECRUITING

Poliklinika LF MEDICAL

Zagreb, 1000, Croatia

RECRUITING

EUC Hradec Kralove Clinic

Hradec Králové, Czechia

WITHDRAWN

Nemocnicni lekarna FN Motol / Motol University Hospital

Prague, 150 06, Czechia

RECRUITING

Forbeli s.r.o.

Prague, Czechia

RECRUITING

Kuopio University Hospital

Kuopio, 70210, Finland

RECRUITING

Hopital Neurologique Pierre Wertheimer

Bron, 69500, France

RECRUITING

Centre Hospitalier Universitaire de Lille (CHU de Lille)

Lille, 59037, France

RECRUITING

Hôpital de la Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Hôpital Fondation A. de Rothschild

Paris, 75019, France

RECRUITING

Chu de Rennes Hôpital Pontchaillou

Rennes, 35033, France

RECRUITING

Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

Universitätsklinikum Aachen

Aachen, D-52074, Germany

RECRUITING

Krankenhaus Mara gGmbH

Bielefeld, 33617, Germany

RECRUITING

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

Frankfurt, 60528, Germany

RECRUITING

Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika

Budapest, 1145, Hungary

RECRUITING

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

The Chaim Sheba Medical Center

Ramat Gan, 6265601, Israel

RECRUITING

Kaplan Medical Center

Rehovot, 76100, Israel

RECRUITING

The Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

RECRUITING

Ospedali Riuniti di Ancona

Ancona, 60126, Italy

WITHDRAWN

Università degli studi di Bari Aldo Moro

Bari, 70124, Italy

RECRUITING

Grupo Medico Camino

Benito Juárez, Mexico

RECRUITING

Human Science Research Trials

Mexico City, 14050, Mexico

RECRUITING

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

Monterrey, Mexico

RECRUITING

Neurocencias Esudios Clinicos S.C.

Sinaloa, 80020, Mexico

RECRUITING

Kempenhaeghe

Heeze, Netherlands

RECRUITING

COPERNICUS Podmiot Leczniczy

Gdansk, Poland

RECRUITING

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

Lublin, 20-064, Poland

WITHDRAWN

Twoja Przychodnia Nowosolskie Centrum Medyczne

Nowa Sól, 67-100, Poland

RECRUITING

MTZ Clinical Research Powered by Pratia

Warsaw, 02-172, Poland

RECRUITING

Neurosphera Sp. z o.o.

Warsaw, 02-829, Poland

RECRUITING

Centro Hospitalar Universitário de Coimbra - CHUC

Coimbra, Portugal

RECRUITING

Hospital da Senhora da Oliveira

Guimarães, 4835-044, Portugal

RECRUITING

Centro Hospitalar de Lisboa Norte

Lisbon, 1649-035, Portugal

RECRUITING

Centro Hospitalar Lisboa Ocidental

Lisbon, Portugal

RECRUITING

Centro Hospitalar Universitário de Santo António

Porto, 4099-001, Portugal

RECRUITING

Hospital Pedro Hispano

Porto, 4464-513, Portugal

RECRUITING

Centro Hospitalar de Entre o Douro e Vouga

Santa Maria da Feira, 520-211, Portugal

RECRUITING

ULS de Trás-os-Montes e Alto Douro

Vila Real, 5000-508, Portugal

RECRUITING

Hospital Universitario Cruces

Barakaldo, 48903, Spain

RECRUITING

Hospital Unversitario Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, 28040, Spain

RECRUITING

Hospital universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Conditions

Seizures; Epilepsy

Interventions

XEN1101

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases

Study Officials

• Xenon Medical Director

  Xenon Pharmaceuticals Inc.

  STUDY DIRECTOR

Central Study Contacts

Xenon Medical Affairs

CONTACT

1-604-484-3300; XenonCares@xenon-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 8, 2023
• Study Start: May 9, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); AU (6); ME (4); AR (12); CR (5); FR (6); DE (3); HU (1); US (18); CZ (3); IL (4); IT (2); NL (1); PL (5); BE (2); BU (2); FI (1); CL (4); PT (8)