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ACTIVE NOT RECRUITING
NCT03796962
PHASE2

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

Sponsor: Xenon Pharmaceuticals Inc.

View on ClinicalTrials.gov

Summary

The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy, followed by an optional open-label extension (OLE).

Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, With an Open-label Extension

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

325

Start Date

2019-01-30

Completion Date

2028-10

Last Updated

2024-09-24

Healthy Volunteers

No

Conditions

Interventions

DRUG

XEN1101

Oral dose

Locations (95)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Strada Patient Care Center

Mobile, Alabama, United States

Xenoscience, Inc.

Phoenix, Arizona, United States

Clinical Trials, Inc.

Little Rock, Arkansas, United States

Altman Clinical Translational Research Institute (ACTRI)

La Jolla, California, United States

California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program

San Francisco, California, United States

University of Colorado Hospital Anschutz Outpatient Pavilion

Aurora, Colorado, United States

University of Florida Jacksonville

Jacksonville, Florida, United States

Mayo Clinic Florida

Jacksonville, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Don Clinical Research Center

Miami, Florida, United States

The Neurology Research Group, LLC.

Miami, Florida, United States

Research Institute of Orlando, LLC

Orlando, Florida, United States

Medsol Clinical Research Center

Port Charlotte, Florida, United States

Tallahassee Neurological Clinic

Tallahassee, Florida, United States

University of South Florida

Tampa, Florida, United States

Georgia Neurology and Sleep Medicine Associate

Suwanee, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, United States

Northwestern Medical Group, Department of Neurology

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Bluegrass Epilepsy Research

Lexington, Kentucky, United States

Maine Medical Partners Neurology

Scarborough, Maine, United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, United States

Boston Neuro Research Center

South Dartmouth, Massachusetts, United States

Minneapolis Clinic of Neurology, Ltd.

Golden Valley, Minnesota, United States

Minnesota Epilepsy Group, P. A.

Saint Paul, Minnesota, United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, United States

Institute of Neurology and Neurosurgery at Saint Barnabas

Livingston, New Jersey, United States

Northeast Regional Epilepsy Group

Morristown, New Jersey, United States

Dent Neurosciences Research Center

Amherst, New York, United States

NYU Langone Medical Center/NYU School of Medicine

New York, New York, United States

Northwell Health - Lenox Hill

New York, New York, United States

SUNY Upstate Medical University Institute for Human Performance

Syracuse, New York, United States

Five Towns Neuroscience Research

Woodmere, New York, United States

Asheville Neurology Specialists, PA

Asheville, North Carolina, United States

UC Gardner Neuroscience Institute

Cincinnati, Ohio, United States

Miami Valley Hospital

Dayton, Ohio, United States

University of Toledo Medical Center

Toledo, Ohio, United States

Providence Neurological Specialties East

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Comprehensive Epilepsy Center

Philadelphia, Pennsylvania, United States

Allegheny Neurological Associates

Pittsburgh, Pennsylvania, United States

Vanderbilt Epilepsy Clinic

Nashville, Tennessee, United States

Austin Epilepsy Care Center

Austin, Texas, United States

James W. Aston Ambulatory Care Center

Dallas, Texas, United States

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

University of Utah Health Clinical Neurosciences Center

Salt Lake City, Utah, United States

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Carilion Neurology Clinic

Roanoke, Virginia, United States

Winchester Neurological Consultants

Winchester, Virginia, United States

UW Medicine Valle Medical Center

Renton, Washington, United States

University of Washington School of Medicine, Regional Epilepsy Center at Harborview Medical Center

Seattle, Washington, United States

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

Vancouver, British Columbia, Canada

London Health Sciences Center

London, Ontario, Canada

University Health Network-Toronto Western Hospital

Toronto, Ontario, Canada

LLC Arensia Exploratory Medicine

Tbilisi, Georgia

Epilepsiezentrum Berlin-Brandenburg

Berlin, Germany

Bethel Epilepsy Centre

Bielefeld, Germany

Univ.-Klinik Bonn, Klinik und Poliklinik fur Epileptologie

Bonn, Germany

Universitatsklinikym Frankfurt

Frankfurt, Germany

Universitatsklinikum Freiburg, Neurozentrum/Epilepsiezentrum

Freiburg im Breisgau, Germany

University Hospital Munster (UKM)

Münster, Germany

Klinikum Osnabruck

Osnabrück, Germany

Krankenhaus Barmherzige Brueder Regensburg

Regensburg, Germany

University of Tubingen-Dept. of Neurology and Epileptology

Tübingen, Germany

IRCCS- Istituto delle Scienze Neurologiche, Bellaria Hospital

Bologna, Italy

Dipartimento Scienze Mediche e Chirurgiche, Universita Magna Graecia di Catanzaro

Catanzaro, Italy

Fondazione IRCCS Istituto Neurologico C. Besta

Milan, Italy

IRCCS Istituto Neurologico Nazionale C. Mondino

Pavia, Italy

Azienda Ospedaliera Universita' Pisana

Pisa, Italy

Azienda Ospedaliera "Bianchi-Melacrino-Morelle"di Reggio Calabria

Reggio Calabria, Italy

Policlinico di Roma Umberto I

Roma, Italy

PMSI Republican Clinical Hospital, ARENSIA Exploratory Medicine

Chisinau, Moldova

Hospital Virgen Macarena

Seville, Andalusia, Spain

Centro de Neurologia Avanzada

Seville, Andalusia, Spain

Hospital Germans Trias I Pujol

Badalona, Barcelona, Spain

Clínica Universidad Navarra

Pamplona, Navarre, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Hospital Vithas La Salud

Granada, Spain

Hospital U. Ramón y Cajal

Madrid, Spain

Hospital Ruber Internacional

Madrid, Spain

Hospital U. Clínico San Carlos

Madrid, Spain

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Regional Universitario de Málaga

Málaga, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Hospital Clínico Universitario Valladolid

Valladolid, Spain

Medical Center of Limited Liability Company "Harmoniya Krasy"

Kyiv, Ukraine

Institute of Neurological Sciences

Glasgow, Scotland, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

King's College Hospital NHS Foundation Trust

London, United Kingdom

St. George's University Hospitals NHS Foundation Trust

London, United Kingdom