Tests XEN1101 as an add-on treatment for generalized tonic-clonic seizures
Tests XEN1101 alongside usual medicine in people with generalized tonic-clonic seizures.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Key facts
- Where
- Akron, Amherst, Ann Arbor, Atlanta, Aurora, Austin, Baltimore, Bethesda, Boise, Boys Town, Charleston, Charlotte, Chestnut Hill, Cleveland, Clinton, Columbus, Detroit, Durham, East Lansing, El Paso, Grand Rapids, Hackensack, Honolulu, Houston, Indianapolis, Jacksonville, Kansas City, Lexington, Little Rock, Los Angeles, Miami, Milwaukee, Mobile, Orange, Orlando, Pensacola, Philadelphia, Phoenix, Pittsburgh, Port Charlotte, Sacramento, Salt Lake City, San Antonio, Seattle, Springfield, St Louis, Suwanee, Syracuse, Tampa, Tucson, Virginia Beach, Weston, Winston-Salem, Woodmere, and Worcester, United StatesSee the 62 sites
- Phase
- Phase 3
Where in United States
- Summa Health Clinical Research CenterAkron, United StatesTaking people
- Dent Neurosciences Research FacilityAmherst, United StatesNo longer taking part
- University of Michigan HospitalsAnn Arbor, United StatesTaking people
- Children's Healthcare of AtlantaAtlanta, United StatesTaking people
- Emory Brain Health CenterAtlanta, United StatesTaking people
- University of Colorado Anschutz Medical CampusAurora, United StatesNo longer taking part
- Child Neurology Consultants of AustinAustin, United StatesTaking people
- MedStar Franklin Square Medical CenterBaltimore, United StatesTaking people
- University of Maryland Medical CenterBaltimore, United StatesTaking people
- Mid-Atlantic Epilepsy and Sleep CenterBethesda, United StatesTaking people
- Consultants in Epilepsy and Neurology PLLCBoise, United StatesTaking people
- Boys Town National Research HospitalBoys Town, United StatesTaking people
- Medical University of South Carolina (MUSC)Charleston, United StatesNo longer taking part
- Atrium HealthCharlotte, United StatesTaking people
- Onsite Clinical Solutions, LLCCharlotte, United StatesTaking people
- Brigham and Women's HospitalChestnut Hill, United StatesTaking people
- Cleveland Clinic FoundationCleveland, United StatesTaking people
- Medstar Georgetown University HospitalClinton, United StatesTaking people
- OhioHealth Riverside Methodist HospitalColumbus, United StatesTaking people
- The Ohio State UniversityColumbus, United StatesTaking people
- Wayne State UniversityDetroit, United StatesTaking people
- Duke University Clinical ResearchDurham, United StatesTaking people
- Michigan State University Department of NeurologyEast Lansing, United StatesTaking people
- ANESC ResearchEl Paso, United StatesTaking people
- Spectrum HealthGrand Rapids, United StatesTaking people
- Northeast Regional Epilepsy GroupHackensack, United StatesTaking people
- Hawaii Pacific Neuroscience, Comprehensive Epilepsy CenterHonolulu, United StatesNo longer taking part
- UTHealth Science Center at HoustonHouston, United StatesTaking people
- Indiana University School of MedicineIndianapolis, United StatesNo longer taking part
- Mayo Clinic FloridaJacksonville, United StatesTaking people
- University of Kansas Medical CenterKansas City, United StatesTaking people
- Bluegrass Epilepsy Research, LLCLexington, United StatesTaking people
- University of Kentucky Albert B. Chandler Hospital (UK Healthcare)Lexington, United StatesTaking people
- University of Arkansas for Medical SciencesLittle Rock, United StatesTaking people
- Brain Science Research InstituteLos Angeles, United StatesTaking people
- Serenity Research Center, LLCMiami, United StatesTaking people
- Advocate Aurora Research institute, St. Luke's Medical CenterMilwaukee, United StatesNo longer taking part
- University of Alabama - Strada Patient Care Center, NeurologyMobile, United StatesNo longer taking part
- University of California, Irvine - Health Neurology ServicesOrange, United StatesTaking people
- Orlando Health Neuroscience InstituteOrlando, United StatesTaking people
- Research Institute of Orlando LLCOrlando, United StatesNo longer taking part
- Panhandle Research and Medical ClinicPensacola, United StatesTaking people
- University of PennsylvaniaPhiladelphia, United StatesTaking people
- Temple University HospitalPhiladelphia, United StatesNo longer taking part
- XenosciencePhoenix, United StatesTaking people
- UPMC Comprehensive Epilepsy CenterPittsburgh, United StatesTaking people
- Medsol Clinical Research Center Harbor Professional CentrePort Charlotte, United StatesNo longer taking part
- University California, Davis Clinical & Translation Science Center Clinical Research (CCRC)Sacramento, United StatesNo longer taking part
- University of Utah Clinical Neurosciences CenterSalt Lake City, United StatesNo longer taking part
- University of Texas Health Science Center at San AntonioSan Antonio, United StatesTaking people
- University of Washington, Regional Epilepsy Center at Harborview Medical CenterSeattle, United StatesTaking people
- Southern Illinois University School of MedicineSpringfield, United StatesTaking people
- Saint Louis University Medical SchoolSt Louis, United StatesTaking people
- Georgia Neurology & Sleep Medicine AssociatesSuwanee, United StatesNo longer taking part
- SUNY Upstate Medical UniversitySyracuse, United StatesTaking people
- University of South FloridaTampa, United StatesTaking people
- University of Arizona - Health Science CenterTucson, United StatesTaking people
- Sentara Neurology SpecialistsVirginia Beach, United StatesTaking people
- Encore Medical Research of Weston, LLCWeston, United StatesTaking people
- Wake Forest Baptist HealthWinston-Salem, United StatesTaking people
- Five Towns NeurologyWoodmere, United StatesNo longer taking part
- Umass Memorial Medical CenterWorcester, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Xenon Pharmaceuticals Inc.
- Trial code
- NCT05667142EU 2022-502286-16-00
- Record updated
- 2 November 2026
- Original 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).Read full original descriptionShow less
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
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).
Inclusion: 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.
Exclusion: Subject has had status epilepticus within the 12 months prior to Visit 1; 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 history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to Visit 1; 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 has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted; 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 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:; 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:; 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.