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

Purpose

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.

Condition

  • Focal Onset Seizures

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
XEN1101 25 mg/day 		XEN1101 25 mg/day
  • Drug: XEN1101
    XEN1101 Capsules
    Other names:
    • Azetukalner
Experimental
XEN1101 15 mg/day 		XEN1101 15 mg/day
  • Drug: XEN1101
    XEN1101 Capsules
    Other names:
    • Azetukalner
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Placebo Capsules

Recruiting Locations

Strada Patient Care Center
Mobile, Alabama 36604

Xenoscience
Phoenix, Arizona 85004

St. Joseph's Hospital
Phoenix, Arizona 85013

University of Arizona, Health Sciences Center
Tucson, Arizona 85724

Clinical Trials, Inc
Little Rock, Arkansas 72205

Brain Science Research Institute
Los Angeles, California 90025

University of California, David Clinical & Translational Science Center Clinical Research (CCRC)
Sacramento, California 95817

Anschutz Health Sciences
Aurora, Colorado 80011

Floridian Community Research Center
Coral Gables, Florida 33134

Serenity Research
Miami, Florida 33176

Research Institute of Orlando, LLC
Orlando, Florida 32806

Panhandle Research & Medical Clinic
Pensacola, Florida 32503

Medsol Clinical Research Center
Port Charlotte, Florida 33952

University of South Florida
Tampa, Florida 33606

Encore Medical Research of Weston, LLC
Weston, Florida 33021

Emory Brain Health Center
Atlanta, Georgia 30329

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817

Consultants in Epilepsy and Neurology
Boise, Idaho 83702

Rush University Medical Center
Chicago, Illinois 60612

Indiana University, IU Health Partners, Adult Neurology Clinic
Indianapolis, Indiana 46202

The University of Kansas Medical Center
Kansas City, Kansas 66160

Bluegrass Epilepsy Research, LLC
Lexington, Kentucky 40504

University of Kentucky, Dept. of Neurology
Lexington, Kentucky 40536-0284

MaineHealth Neurology - Scarborough
Scarborough, Maine 04074

University of Maryland Medical Center
Baltimore, Maryland 21201

Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817

MedStar Health Research Institute
Clinton, Maryland 20735

Medstar Health Research Institute
Hyattsville, Maryland 20782

Brigham and Women's Hospital
Boston, Massachusetts 02115

UMass Memorial Medical Center
Worcester, Massachusetts 01655

University of Michigan
Ann Arbor, Michigan 48109

Michigan State University
East Lansing, Michigan 48824

Cornwell Health
Grand Rapids, Michigan 49506

Minneapolis Clinic of Neurology
Burnsville, Minnesota 55337

Saint Louis University Medical School - Neurosciences Clinical Research Unit
Saint Louis, Missouri 63104

Washington University, St. Louis
Saint Louis, Missouri 63110

Northeast Epilepsy Group
Hackensack, New Jersey 07601

Montefiore Medical Center
Bronx, New York 10467-2401

Dent Neurosciences Research Center
Buffalo, New York 14226

NYU Comprehensive Epilepsy Center (CEC)
New York, New York 10016

Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York 10021

Mount Sinai Medical Center
New York, New York 10029

SUNY Upstate Medical University
Syracuse, New York 13210

Onsite Clinical Solutions, LLC
Charlotte, North Carolina 28211

Duke Neurology
Durham, North Carolina 27713

Meridian Clinical Research, LLC
Raleigh, North Carolina 27607

Wake Forest Baptist Health
Winston-Salem, North Carolina 27157

Summa Health
Akron, Ohio 44304

Providence Brain & Spine Institute
Portland, Oregon 97225

Thomas Jefferson University
Philadelphia, Pennsylvania 19107

Temple University Hospital
Philadelphia, Pennsylvania 19140-4105

Austin Epilepsy Care Center (AECC)
Austin, Texas 78758

ANESC Research
El Paso, Texas 79912

UT Physicians Epilepsy Clinic
Houston, Texas 77030

UT Health San Antonio
San Antonio, Texas 78229

Carilion Clinic - Neurology
Roanoke, Virginia 24013

Sentara Neurology Specialists
Virginia Beach, Virginia 23456

University of Washington Main Hospital
Seattle, Washington 98104

Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215

More Details

NCT ID
NCT05614063
Status
Recruiting
Sponsor
Xenon Pharmaceuticals Inc.

Study Contact

Xenon Medical Affairs
1-604-484-3300
XenonCares@xenon-pharma.com

Detailed Description

Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal. Subjects who complete the 12-week DBP will have the opportunity to qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.

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Vanderbilt University Medical Center