A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Recruiting · NCT05667142 · Interventional (participants receive a specific treatment) · Lead sponsor: Xenon Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboXEN1101
What this trial is about
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).
Who can take part
Age range
12 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
- Subject is ≥12 years of age with a BMI ≤40 kg/m2 at Visit 1.
- 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.
- 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).
- Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 3 months prior to the planned randomization (Visit 2), during screening/baseline, and throughout the DBP.
- Subject is able to keep accurate seizure diaries.
- Key
Exclusion criteria
- Subject has had status epilepticus within the 12 months prior to Visit 1.
- Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1.
- Subject has a concomitant diagnosis of focal-onset seizures (FOS).
- Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- 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 central nervous system (CNS) disease.
- Subject has history of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to Visit 1.
- Subject has schizophrenia and other psychotic disorders (eg, schizophreniform disorder, schizoaffective disorder, psychosis not otherwise specified), bipolar disorder, or another serious mental health disorder. Subject has uncontrolled unipolar major depression where changes in pharmacotherapy are needed or anticipated during the study.
- 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:
- a. History or presence of long QT syndrome; QTcF \>450 msec at baseline; family history of sudden death of unknown cause.
- Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol.
- The criteria to be eligible for randomization are:
- During the last 56 days 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. Retrospective seizure data documented up to 4 weeks prior to Visit 1 may be used in combination with a minimum of 4 weeks of prospective seizure data recorded in the study eDiary.
- Study eDiary was completed a minimum of 80% of all applicable days during the last 28-56 days of the baseline period that preceded randomization as evidence of adequate compliance (eg, \>45 of 56 days, if no retrospective data prior to Visit 1 are used).
- Subject did not change dose of, stop, or initiate any new ASM(s) during the 3 months that preceded randomization and plans on maintaining a stable dose of ASM(s) during the DBP.
Where it is running
60 locations listed across 28 US states.
- 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
- Universitätsklinikum Aachen - Aachen, Germany
Showing 60 of 138 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →