RecruitingPhase 3NCT05667142

A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Sponsor

Xenon Pharmaceuticals Inc.

Enrollment

160 participants

Start Date

Feb 14, 2023

Study Type

INTERVENTIONAL

Conditions

Primary Generalized Tonic-Clonic Seizures

Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).

Eligibility

Min Age: 12 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 primary generalized tonic-clonic seizures. The study is currently recruiting participants at 138 locations. People eligible for this study include aged 12 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(138)

University of Alabama - Strada Patient Care Center, Neurology

Mobile, Alabama, United States

Xenoscience

Phoenix, Arizona, United States

University of Arizona - Health Science Center

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Brain Science Research Institute

Los Angeles, California, United States

University of California, Irvine - Health Neurology Services

Orange, California, United States

University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)

Sacramento, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Serenity Research Center, LLC

Miami, Florida, United States

Research Institute of Orlando, LLC

Orlando, Florida, United States

Panhandle Research and Medical Clinic

Pensacola, Florida, United States

Medsol Clinical Research Center Harbor Professional Centre

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

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Georgia Neurology & Sleep Medicine Associates

Suwanee, Georgia, United States

Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center

Honolulu, Hawaii, United States

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Bluegrass Epilepsy Research, LLC

Lexington, Kentucky, United States

University of Kentucky Albert B. Chandler Hospital (UK Healthcare)

Lexington, Kentucky, 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

Chestnut Hill, Massachusetts, United States

UMass Memorial Medical Center

Worcester, Massachusetts, United States

University of Michigan Hospitals

Ann Arbor, Michigan, United States

Wayne State University

Detroit, Michigan, United States

Michigan State University Department of Neurology

East Lansing, Michigan, United States

Spectrum Health

Grand Rapids, Michigan, United States

Saint Louis University Medical School

St Louis, Missouri, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Dent Neurosciences Research Facility

Amherst, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Five Towns Neurology

Woodmere, New York, United States

Atrium Health

Charlotte, North Carolina, United States

Onsite Clinical Solutions, LLC

Charlotte, North Carolina, United States

Duke University Clinical Research

Durham, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Summa Health Clinical Research Center

Akron, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

UPMC Comprehensive Epilepsy Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

ANESC Research

El Paso, Texas, United States

UTHealth Science Center at Houston

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Utah Clinical Neurosciences Center

Salt Lake City, Utah, United States

Sentara Neurology Specialists

Virginia Beach, Virginia, United States

University of Washington, Regional Epilepsy Center at Harborview Medical Center

Seattle, Washington, United States

Advocate Aurora Research institute, St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Hospital General de Agudos J.M. Ramos Mejia

Buenos Aires, Argentina

STAT Research S.A.

Buenos Aires, Argentina

Hospital Italiano

Buenos Aires, Argentina

Sanatorio del Sur S.A

San Miguel de Tucumán, Argentina

Southern Neurology

Kogarah, New South Wales, Australia

Mater Misericordiae Ltd

South Brisbane, Queensland, Australia

The Alfred Hospital

Melbourne, VC, Australia

Austin Health Pharmacy Clinical Trials

Heidelberg, Victoria, Australia

St Vincent's Hospital Melbourne, Clinical Neurosciences

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Australia

University Hospital Innsbruck

Innsbruck, Austria

Universitaetsklinik fuer Kinder

Linz, Austria

Universitätsklinik für Neurologie

Salzburg, Austria

Universitätsklinik für Neurologie, Medizinische Universität Wien

Vienna, Austria

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Universitair Ziekenhuis Gent

Ghent, Belgium

Multiprofile hospital for active treatment Puls AD

Blagoevgrad, Bulgaria

MHATNP 'Sveti Naum' EAD

Sofia, Bulgaria

First University Multiprofile Hospital for Active Treatment Sofia Sv. Joan Krastitel

Sofia, Bulgaria

Center for Neurologic Research

Lethbridge, Alberta, Canada

Children and Women's Health Centre of BC (BC Children's Hospital)

Vancouver, British Columbia, Canada

London Health Sciences Center

London, Ontario, Canada

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

Montreal, Quebec, Canada

Centro de investigación Clinica UC-CICUC

Santiago, Chile

Clinical Hospital Center Osijek

Osijek, Croatia

Clinical Hospital Center Rijeka

Rijeka, Croatia

University Hospital Center Zagreb

Zagreb, Croatia

Fakultni nemocnice v Motole Neurologicka klinika 2. LF UK a FN Motol

Prague, Czechia

CHU de Lille, Hôpital Roger Salengro - Neurophysiologie clinique

Lille, France

Hopital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

Lyon, France

Hôpital Fondation A. de Rothschild

Paris, France

CHU de Rennes - Hôpital Pontchaillou

Rennes, France

CHU de Strasbourg - Hôpital de Hautepierre

Strasbourg, France

Universitätsklinikum Aachen

Aachen, Germany

Vivantes Humboldt Klinikum

Berlin, Germany

Bethel Epilepsy Centre

Bielefeld, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

Epilepsiezentrum im Neuozentrum

Freiburg im Breisgau, Germany

Philipps-Universität Marburg

Marburg, Germany

Klinikum der Universität München

München, Germany

Epilepsiezentrum Kleinwachau gemeinnützige GmbH

Radeberg, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Universitätsklinikum Ulm

Ulm, Germany

Hadassah University 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

Azienda Ospedaliero Universitaria Ospedali Riuniti Ancona

Ancona, Italy

Università Degli Studi Gabriele d'Annunzio Di Chieti

Chieti, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Ospedalo Pediatrico Bambino Gesu

Roma, Italy

Policlinico Umberto I

Roma, Italy

Grupo Medico Camino SC

Mexico City, Mexico

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

Mexico City, Mexico

Neurociencias Estudios Clínicos S.C

Sinaloa, Mexico

Kempenhaeghe

Heeze, Netherlands

Centrum Medyczne Neuromed

Bydgoszcz, Poland

COPERNICUS Podmiot Leczniczy Sp. z o.o.

Gdansk, Poland

Novo-Med Zielinski I Wspolnicy Sp. J.

Katowice, Poland

NZOZ Neuromed M. i M.

Lublin, Poland

Twoja Przychodnia Nowosolskie Centrum Medyczne

Nowa Sól, Poland

Centro Hospitalar Universitário de Coimbra (CHUC)

Coimbra, Portugal

Hospital da Senhora da Oliveira

Guimarães, Portugal

Centro Hospitalar Lisboa Ocidental, Hospital Egas Moniz

Lisbon, Portugal

Centre Hospitalar Universitario de Lisboa Norte (CHULN)

Lisbon, Portugal

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, Portugal

Centro Hospitalar Universitário de Santo António

Porto, Portugal

Centro Hospitalar de Entre o Douro e Vouga

Santa Maria da Feira, Portugal

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Vithas Madrid La Milagrosa

Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Hospital Clinico Universitario de Valladolid

Valladolid, Spain

Hospital Clinico Viña del Mar

Valparaíso, Spain

University Hospital of Wales

Cardiff, Wales, United Kingdom

Mid Yorkshire Hospitals NHS Trust

Wakefield, West Yorkshire, United Kingdom

St George's University Hospitals NHS Foundation Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

John Radcliffe Hospital

Oxford, United Kingdom

Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)

Salford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05667142

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