RECRUITING

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

Conditions

Primary Generalized Tonic-Clonic Seizures Epilepsy

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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

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).

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 Primary Generalized Tonic-Clonic Seizures

Quick Facts

Study Start:2023-02-14

Study Completion:2025-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05667142

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:12 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study. 2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1. 3. 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. 4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC). 5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP. 6. Subject is able to keep accurate seizure diaries.	1. Subject has had status epilepticus within the 12 months prior to Visit 1. 2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted. 3. Subject has a history of non-epileptic psychogenic seizures. 4. Subject has a concomitant diagnosis of FOS. 5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome. 6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease. 7. Subject has history of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to Visit 1. 8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, obsessive-compulsive disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study. 9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to: 10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol. 1. During the last 56 days of the baseline period that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including ≥1 PGTCS during each of the first and second 4-week periods preceding randomization. 2. Seizure diary was completed a minimum of 80% of all days (ie, ≥45 days) during the last 56 days of the baseline period that preceded randomization as evidence of adequate compliance. 3. Subject did not change dose of, stop, or initiate any new ASM(s) during the baseline period and plans on maintaining a stable dose of ASM(s) during the DBP.

Inclusion Criteria

Exclusion Criteria

1. Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study (for adult subjects) and for adolescent subjects parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
2. Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
3. 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.
4. Subject has probable or possible PGTCS (with or without other subtypes of generalized seizures) for ≥1 year, in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by The Epilepsy Study Consortium (TESC).
5. Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
6. Subject is able to keep accurate seizure diaries.

1. Subject has had status epilepticus within the 12 months prior to Visit 1.
2. Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
3. Subject has a history of non-epileptic psychogenic seizures.
4. Subject has a concomitant diagnosis of FOS.
5. Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
6. Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease.
7. Subject has history of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to Visit 1.
8. Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, obsessive-compulsive disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
9. Subject has any clinically significant laboratory abnormalities or clinically significant abnormalities on prestudy physical examination, vital signs, or ECG that, in the judgment of the investigator, indicate a medical problem that would preclude study participation, including but not limited to:
10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.
1. During the last 56 days of the baseline period that preceded the randomization visit (Visit 2), subject must have had a sufficient documented seizure frequency of PGTCS, including ≥1 PGTCS during each of the first and second 4-week periods preceding randomization.
2. Seizure diary was completed a minimum of 80% of all days (ie, ≥45 days) during the last 56 days of the baseline period that preceded randomization as evidence of adequate compliance.
3. Subject did not change dose of, stop, or initiate any new ASM(s) during the baseline period and plans on maintaining a stable dose of ASM(s) during the DBP.

Contacts and Locations

Study Contact

Xenon Medical Affairs

CONTACT

1-604-484-3300

XenonCares@xenon-pharma.com

Principal Investigator

Medical Director

STUDY_DIRECTOR

Xenon Pharmaceuticals Inc.

Study Locations (Sites)

University of Alabama - Strada Patient Care Center, Neurology

Mobile, Alabama, 36604

United States

Xenoscience

Phoenix, Arizona, 85004

United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Brain Science Research Institute

Los Angeles, California, 90025

United States

University of California, Irvine - Health Neurology Services

Orange, California, 92868

United States

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

Sacramento, California, 95817

United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Serenity Research Center, LLC

Miami, Florida, 33176

United States

Research Institute of Orlando, LLC

Orlando, Florida, 32806

United States

Panhandle Research and Medical Clinic

Pensacola, Florida, 32503

United States

Medsol Clinical Research Center Harbor Professional Centre

Port Charlotte, Florida, 33952

United States

University of South Florida

Tampa, Florida, 33606

United States

Encore Medical Research of Weston, LLC

Weston, Florida, 33331

United States

Emory Brain Health Center

Atlanta, Georgia, 30329

United States

Georgia Neurology & Sleep Medicine Associates

Suwanee, Georgia, 30024

United States

Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center

Honolulu, Hawaii, 96817

United States

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, 83702

United States

Southern Illinois University School of Medicine

Springfield, Illinois, 62794

United States

Indiana University School of Medicine

Indianapolis, Indiana, 46202

United States

University of Kansas Medical Center

Kansas City, Kansas, 66160

United States

Bluegrass Epilepsy Research, LLC

Lexington, Kentucky, 40504

United States

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

Lexington, Kentucky, 40536

United States

University of Maryland Medical Center

Baltimore, Maryland, 21201

United States

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817

United States

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467

United States

UMass Memorial Medical Center

Worcester, Massachusetts, 01655

United States

University of Michigan Hospitals

Ann Arbor, Michigan, 48109

United States

Wayne State University

Detroit, Michigan, 48201

United States

Michigan State University Department of Neurology

East Lansing, Michigan, 48824

United States

Spectrum Health

Grand Rapids, Michigan, 49503

United States

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601

United States

Dent Neurosciences Research Facility

Amherst, New York, 14226

United States

SUNY Upstate Medical University

Syracuse, New York, 13201

United States

Five Towns Neurology

Woodmere, New York, 11598

United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27104

United States

Summa Health Clinical Research Center

Akron, Ohio, 44304

United States

Cleveland Clinic Foundation

Cleveland, Ohio, 44195

United States

The Ohio State University

Columbus, Ohio, 43210

United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio, 43214

United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Temple University Hospital

Philadelphia, Pennsylvania, 19140

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425

United States

ANESC Research

El Paso, Texas, 79912

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

University of Utah Clinical Neurosciences Center

Salt Lake City, Utah, 84132

United States

Sentara Neurology Specialists

Virginia Beach, Virginia, 23456

United States

University of Washington, Regional Epilepsy Center at Harborview Medical Center

Seattle, Washington, 98104

United States

Advocate Aurora Research institute, 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 Date2023-02-14

Study Completion Date2025-10

Study Record Updates

Study Start Date2023-02-14

Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

Epilepsy

Additional Relevant MeSH Terms

Primary Generalized Tonic-Clonic Seizures