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COMPLETED
NCT05614063
PHASE3

A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

Sponsor: Xenon Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

The X-TOLE2 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.

Official title: A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

380

Start Date

2022-11-18

Completion Date

2026-02-03

Last Updated

2026-05-14

Healthy Volunteers

No

Interventions

DRUG

XEN1101

XEN1101 Capsules

DRUG

Placebo

Placebo Capsules

Locations (125)

Strada Patient Care Center

Mobile, Alabama, United States

Xenoscience

Phoenix, Arizona, United States

University of Arizona, Health Sciences Center

Tucson, Arizona, United States

Clinical Trials, Inc

Little Rock, Arkansas, United States

Brain Science Research Institute

Los Angeles, California, United States

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

Sacramento, California, United States

Anschutz Health Sciences

Aurora, Colorado, United States

Serenity Research

Miami, Florida, United States

Research Institute of Orlando, LLC

Orlando, Florida, United States

Panhandle Research & Medical Clinic

Pensacola, Florida, United States

Medsol Clinical Research Center

Port Charlotte, Florida, United States

University of South Florida

Tampa, Florida, United States

Encore Medical Research of Weston, LLC

Weston, Florida, United States

Emory Brain Health Center

Atlanta, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Consultants in Epilepsy and Neurology

Boise, Idaho, United States

Indiana University, IU Health Partners, Adult Neurology Clinic

Indianapolis, Indiana, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Bluegrass Epilepsy Research, LLC

Lexington, Kentucky, United States

University of Kentucky, Dept. of Neurology

Lexington, Kentucky, United States

MaineHealth Neurology - Scarborough

Scarborough, Maine, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Medstar Franklin Square Medical Center

Baltimore, Maryland, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

MedStar Georgetown University Hospital

Clinton, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Michigan State University

East Lansing, Michigan, United States

Cornwell Health

Grand Rapids, Michigan, United States

Minneapolis Clinic of Neurology

Burnsville, Minnesota, United States

Saint Louis University Medical School - Neurosciences Clinical Research Unit

St Louis, Missouri, United States

Washington University, St. Louis

St Louis, Missouri, United States

Northeast Epilepsy Group

Hackensack, New Jersey, United States

Dent Neurosciences Research Center

Buffalo, New York, United States

NYU Comprehensive Epilepsy Center (CEC)

New York, New York, United States

Weill Cornell Medicine/ New York-Presbyterian Hospital

New York, New York, United States

Mount Sinai Medical Center

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Onsite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Duke Neurology

Durham, North Carolina, United States

Meridian Clinical Research, LLC

Raleigh, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Summa Health

Akron, Ohio, United States

Providence Brain & Spine Institute

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Austin Epilepsy Care Center (AECC)

Austin, Texas, United States

ANESC Research

El Paso, Texas, United States

UT Physicians Epilepsy Clinic

Houston, Texas, United States

UT Health San Antonio

San Antonio, Texas, United States

Carilion Clinic - Neurology

Roanoke, Virginia, United States

Sentara Neurology Specialists

Virginia Beach, Virginia, United States

University of Washington Main Hospital

Seattle, Washington, United States

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

INECO and Favoloro Fundation

Buenos Aires, Argentina

Hospital General de Agudos J.M. Ramos Mejia

Buenos Aires, Argentina

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

Buenos Aires, Argentina

STAT Research S.A.

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

CENyR

Caba, Argentina

Hospital Córdoba

Córdoba, Argentina

Sanatorio del Sur S.A.

San Miguel de Tucumán, Argentina

St Vincent's Hospital Melbourne

Fitzroy, Melbourne, Australia

Royal Prince Alfred Hospital (RAPH)

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Sydney, New South Wales, Australia

Southern Neurology

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

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

Brisbane, Queensland, Australia

Austin Health Pharmacy Clinical Trials

Heidelberg, Victoria, Australia

The Alfred Hospital (Alfred Health)

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Melbourne, Australia

MHAT Puls AD

Blagoevgrad, Bulgaria

Center For Neurologic Research

Lethbridge, Alberta, Canada

London Health Sciences Centre

London, Ontario, Canada

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

Montreal, Quebec, Canada

Centro de investigación Clinica UC

Santiago, Chile

Hospital Clínico Vina del Mar

Viña del Mar, Chile

FORBELI s.r.o., Neurologicka ambulance

Prague, Czechia

American Hospital Network LLC

Tbilisi, Georgia

Institute of Neurology and Neuropsychology

Tbilisi, Georgia

Epilepsy Center Bethel

Bielefeld, Germany

Universitatsklinikum Bonn

Bonn, Germany

Epilepsiezentrum Frankfurt Rhein-Main

Frankfurt, Germany

University Medical Center Freiburg

Freiburg im Breisgau, Germany

Philipps-Universität Marburg

Marburg, Germany

LMU Munich, Department of Neurology

Munich, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitatsklinik fur neurologie, universitats - und Rehabilitationskliniken Ulm

Ulm, Germany

Beaumont Hospital

Dublin, Ireland

Istituto delle Scienze Neurologiche di Bologna

Bologna, Italy

Università Degli Studi Gabriele d'Annunzio Di Chieti

Pescara, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Azienda Ospedaliero-Universitaria Policlinico Umberto I

Rome, Italy

Pauls Stradina Clinical university hospital

Riga, Latvia

Riga East University Hospital

Riga, Latvia

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

Mexico City, Mexico

Neurocencias Esudios Clinicos SC

Sinaloa, Mexico

University of Auckland

Auckland, New Zealand

Waikato Hospital

Hamilton, New Zealand

Centrum Medyczne Neuromed

Bydgoszcz, Poland

NZOZ Novo-Med

Katowice, Poland

Twoja Przychodnia NCM

Nowa Sól, Poland

Neurosphera Sp. z o.o.

Warsaw, Poland

Unidade Local de Saúde de São João

Porto, Portugal

Hospital Pedro Hispano

Porto, Portugal

Centro Hospitalar de Entre o Douro e Vouga

Santa Maria da Feira, Portugal

Unitat d'Assaigs Clínics. Servei de Farmàcia

Barcelona, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital Vithas La Milagrosa

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

IIS-Fundacion Jimenez Diaz/Farmacia

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional De Malaga

Málaga, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain

Hospital Clínico Universitario Valladolid

Valladolid, Spain

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

University Hospital of Wales

Cardiff, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

St. George's Hospital NHS Foundation Trust

London, United Kingdom

Royal London Hospital for Integrated Medicine

London, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

Northern Care Alliance NHS Foundation Trust, Salford Care Organisation

Salford, United Kingdom