RecruitingPhase 3NCT05716100

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

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

Sponsor

Xenon Pharmaceuticals Inc.

Enrollment

360 participants

Start Date

May 9, 2023

Study Type

INTERVENTIONAL

Conditions

Focal Onset Seizures

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called XEN1101 for people with focal onset seizures. The study is currently recruiting participants at 95 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGXEN1101

XEN1101 Capsules

DRUGPlacebo

Placebo Capsules

Locations(95)

Clinical Trials, Inc.

Little Rock, Arkansas, United States

Rancho Research Institute

Downey, California, United States

University of California Los Angeles (UCLA)

Los Angeles, California, United States

University of California Irvine Health

Orange, California, United States

Panhandle Research and Medical Clinic

Gulf Breeze, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

9D University Health Center

Detroit, Michigan, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Five Towns Neuroscience Research

Woodmere, New York, United States

Duke University Clinic

Durham, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

OhioHealth

Columbus, Ohio, United States

Providence Neurological Specialities

Portland, Oregon, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Austin Epilepsy Care Center

Austin, Texas, United States

University of Utah Clinical Neurosciences Center

Salt Lake City, Utah, United States

Hospital Ramos Mejia

Buenos Aires, Argentina

Hospital De Alta Complejidad en Red el Cruce

Buenos Aires, Argentina

Policlinico Lomas

Buenos Aires, Argentina

Instituto de Neurologia Cognitiva (INECO)

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

Buenos Aires, Argentina

STAT Resarch S.A.

Buenos Aires, Argentina

CENyR Centro de Especialidades Neurologicas y Rehabilitacion

C.a.b.a., Argentina

FLENI

C.a.b.a., Argentina

Hospital Córdoba

Córdoba, Argentina

Hospital Central Ramon Carrilo

San Luis, Argentina

Sanatori del Sur S.A.

San Miguel de Tucumán, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Alfred Hospital

Melbourne, Victoria, Australia

Austin Health

Melbourne, Victoria, Australia

Royal Melbourne Hospital

Melbourne, Australia

University Hospital Innsbruck

Innsbruck, Austria

Universitätsklinik für Neurologie

Salzburg, Austria

Medical University of Vienna

Vienna, Austria

Cliniques Universitaires Saint-Luc (UCL)

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

MHATNPsy Sveti Naum EAD

Sofia, Bulgaria

Medical center OPHTHA-NEURO

Sofia, Bulgaria

Clinica Universidad de Los Andes

Santiago, Chile

Centro de Investigacion Clinica UC

Santiago, Chile

CINSAN

Santiago, Chile

Hospital Clínico Viña del Mar

Viña del Mar, Chile

University Hospital Center Osijek

Osijek, Croatia

Clinical Hospital Center Rijeka, Klinika za Neurologiju

Rijeka, Croatia

Poliklinika Bonifarm

Zagreb, Croatia

University Hospital Center Zagreb

Zagreb, Croatia

Poliklinika LF MEDICAL

Zagreb, Croatia

EUC Hradec Kralove Clinic

Hradec Králové, Czechia

Nemocnicni lekarna FN Motol / Motol University Hospital

Prague, Czechia

Forbeli s.r.o.

Prague, Czechia

Kuopio University Hospital

Kuopio, Finland

Hopital Neurologique Pierre Wertheimer

Bron, France

Centre Hospitalier Universitaire de Lille (CHU de Lille)

Lille, France

Hôpital de la Pitié Salpêtrière

Paris, France

Hôpital Fondation A. de Rothschild

Paris, France

Chu de Rennes Hôpital Pontchaillou

Rennes, France

Hôpital de Hautepierre

Strasbourg, France

Universitätsklinikum Aachen

Aachen, Germany

Krankenhaus Mara gGmbH

Bielefeld, Germany

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

Frankfurt, Germany

Semmelweis Egyetem, Idegsebészeti és Neurointervenciós Klinika

Budapest, Hungary

Hadassah Medical Center

Jerusalem, Israel

The Chaim Sheba Medical Center

Ramat Gan, Israel

Kaplan Medical Center

Rehovot, Israel

The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Ospedali Riuniti di Ancona

Ancona, Italy

Università degli studi di Bari Aldo Moro

Bari, Italy

Grupo Medico Camino

Benito Juárez, Mexico

Human Science Research Trials

Mexico City, Mexico

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

Monterrey, Mexico

Neurocencias Esudios Clinicos S.C.

Sinaloa, Mexico

Kempenhaeghe

Heeze, Netherlands

COPERNICUS Podmiot Leczniczy

Gdansk, Poland

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

Lublin, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne

Nowa Sól, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Poland

Neurosphera Sp. z o.o.

Warsaw, Poland

Centro Hospitalar Universitário de Coimbra - CHUC

Coimbra, Portugal

Hospital da Senhora da Oliveira

Guimarães, Portugal

Centro Hospitalar de Lisboa Norte

Lisbon, Portugal

Centro Hospitalar Lisboa Ocidental

Lisbon, Portugal

Centro Hospitalar Universitário de Santo António

Porto, Portugal

Hospital Pedro Hispano

Porto, Portugal

Centro Hospitalar de Entre o Douro e Vouga

Santa Maria da Feira, Portugal

ULS de Trás-os-Montes e Alto Douro

Vila Real, Portugal

Hospital Universitario Cruces

Barakaldo, Spain

Hospital Unversitario Ramon y Cajal

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital universitario Fundación Jiménez Díaz

Madrid, Spain

View Full Details on ClinicalTrials.gov

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NCT05716100

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