ACTIVE_NOT_RECRUITING

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

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Conditions

Focal Onset SeizuresEpilepsy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2022-11-18
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05614063

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
  2. * 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.
  3. * 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
  4. * Able to keep accurate seizure diaries
  1. * Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
  2. * History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
  3. * 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.
  4. * History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
  5. * History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
  6. * 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.

Contacts and Locations

Principal Investigator

Medical Director
STUDY_DIRECTOR
Xenon Pharmaceuticals Inc.

Study Locations (Sites)

Strada Patient Care Center
Mobile, Alabama, 36604
United States
Xenoscience
Phoenix, Arizona, 85004
United States
University of Arizona, Health Sciences Center
Tucson, Arizona, 85724
United States
Clinical Trials, Inc
Little Rock, Arkansas, 72205
United States
Brain Science Research Institute
Los Angeles, California, 90025
United States
University of California, David Clinical & Translational Science Center Clinical Research (CCRC)
Sacramento, California, 95817
United States
Anschutz Health Sciences
Aurora, Colorado, 80011
United States
Floridian Community Research Center
Coral Gables, Florida, 33134
United States
Serenity Research
Miami, Florida, 33176
United States
Research Institute of Orlando, LLC
Orlando, Florida, 32806
United States
Panhandle Research & Medical Clinic
Pensacola, Florida, 32503
United States
Medsol Clinical Research Center
Port Charlotte, Florida, 33952
United States
University of South Florida
Tampa, Florida, 33606
United States
Encore Medical Research of Weston, LLC
Weston, Florida, 33021
United States
Emory Brain Health Center
Atlanta, Georgia, 30329
United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, 96817
United States
Consultants in Epilepsy and Neurology
Boise, Idaho, 83702
United States
Indiana University, IU Health Partners, Adult Neurology Clinic
Indianapolis, Indiana, 46202
United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Bluegrass Epilepsy Research, LLC
Lexington, Kentucky, 40504
United States
University of Kentucky, Dept. of Neurology
Lexington, Kentucky, 40536-0284
United States
MaineHealth Neurology - Scarborough
Scarborough, Maine, 04074
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, 20817
United States
MedStar Health Research Institute
Clinton, Maryland, 20735
United States
Medstar Health Research Institute
Hyattsville, Maryland, 20782
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Michigan State University
East Lansing, Michigan, 48824
United States
Cornwell Health
Grand Rapids, Michigan, 49506
United States
Minneapolis Clinic of Neurology
Burnsville, Minnesota, 55337
United States
Saint Louis University Medical School - Neurosciences Clinical Research Unit
St Louis, Missouri, 63104
United States
Washington University, St. Louis
St Louis, Missouri, 63110
United States
Northeast Epilepsy Group
Hackensack, New Jersey, 07601
United States
Dent Neurosciences Research Center
Buffalo, New York, 14226
United States
NYU Comprehensive Epilepsy Center (CEC)
New York, New York, 10016
United States
Weill Cornell Medicine/ New York-Presbyterian Hospital
New York, New York, 10021
United States
Mount Sinai Medical Center
New York, New York, 10029
United States
SUNY Upstate Medical University
Syracuse, New York, 13210
United States
Montefiore Medical Center
The Bronx, New York, 10467-2401
United States
Onsite Clinical Solutions, LLC
Charlotte, North Carolina, 28211
United States
Duke Neurology
Durham, North Carolina, 27713
United States
Meridian Clinical Research, LLC
Raleigh, North Carolina, 27607
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States
Summa Health
Akron, Ohio, 44304
United States
Providence Brain & Spine Institute
Portland, Oregon, 97225
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140-4105
United States
Austin Epilepsy Care Center (AECC)
Austin, Texas, 78758
United States
ANESC Research
El Paso, Texas, 79912
United States
UT Physicians Epilepsy Clinic
Houston, Texas, 77030
United States
UT Health San Antonio
San Antonio, Texas, 78229
United States
Carilion Clinic - Neurology
Roanoke, Virginia, 24013
United States
Sentara Neurology Specialists
Virginia Beach, Virginia, 23456
United States
University of Washington Main Hospital
Seattle, Washington, 98104
United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
United States

Collaborators and Investigators

Sponsor: Xenon Pharmaceuticals Inc.

  • Medical Director, STUDY_DIRECTOR, Xenon Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-18
Study Completion Date2026-02

Study Record Updates

Study Start Date2022-11-18
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • Epilepsy

Additional Relevant MeSH Terms

  • Focal Onset Seizures