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Clinical Trials in the UK / NCT05667142
Recruiting Phase 3

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

NCT05667142 · tracked via the Priya Life Science UK tracker
Sponsor
Xenon Pharmaceuticals Inc.
Phase
Phase 3
Started
2023-02-14
Last updated
2026-08-10

Condition(s) studied

Primary Generalized Tonic-Clonic Seizures

Investigational drug(s) / intervention(s)

XEN1101Placebo

XEN1101: XEN1101 capsules

Placebo: Placebo capsules

Study summary

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).

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
Key Inclusion 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 3 months prior to the planned randomization (Visit 2), during screening/baseline, and throughout the DBP. 6. Subject is able to keep accurate seizure diaries. Key Exclusion Criteria: 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 within 10 years prior to Visit 1. 4. Subject has a concomitant diagnosis of focal-onset seizures (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 central nervous system (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, 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: a. History or presence of long QT syndrome; QTcF \>450 msec at baseline; family history of sudden death of unknown cause. 10. Any personal circumstance that, in the opinion of the investigator, prevents adherence to the protocol. The criteria to be eligible for randomization are: 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. 2. 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). 3. 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.

Primary outcome measure(s)

Trial sites (138)

FacilityCityRegionStatus
University of Alabama - Strada Patient Care Center, Neurology Mobile Alabama Recruiting
Xenoscience Phoenix Arizona Recruiting
University of Arizona - Health Science Center Tucson Arizona Recruiting
University of Arkansas for Medical Sciences Little Rock Arkansas Recruiting
Brain Science Research Institute Los Angeles California Recruiting
University of California, Irvine - Health Neurology Services Orange California Recruiting
University California, Davis Clinical & Translation Science Center Clinical Research (CCRC) Sacramento California Withdrawn
University of Colorado Anschutz Medical Campus Aurora Colorado Withdrawn
Mayo Clinic Florida Jacksonville Florida Recruiting
Serenity Research Center, LLC Miami Florida Recruiting
Research Institute of Orlando, LLC Orlando Florida Terminated
Panhandle Research and Medical Clinic Pensacola Florida Recruiting
Medsol Clinical Research Center Harbor Professional Centre Port Charlotte Florida Recruiting
University of South Florida Tampa Florida Recruiting
Encore Medical Research of Weston, LLC Weston Florida Recruiting
Emory Brain Health Center Atlanta Georgia Recruiting
Children's Healthcare of Atlanta Atlanta Georgia Recruiting
Georgia Neurology & Sleep Medicine Associates Suwanee Georgia Withdrawn
Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center Honolulu Hawaii Withdrawn
Consultants in Epilepsy and Neurology, PLLC Boise Idaho Recruiting
Southern Illinois University School of Medicine Springfield Illinois Recruiting
Indiana University School of Medicine Indianapolis Indiana Withdrawn
University of Kansas Medical Center Kansas City Kansas Recruiting
Bluegrass Epilepsy Research, LLC Lexington Kentucky Recruiting
University of Kentucky Albert B. Chandler Hospital (UK Healthcare) Lexington Kentucky Recruiting
University of Maryland Medical Center Baltimore Maryland Recruiting
MedStar Franklin Square Medical Center Baltimore Maryland Recruiting
Mid-Atlantic Epilepsy and Sleep Center Bethesda Maryland Recruiting
Medstar Georgetown University Hospital Clinton Maryland Recruiting
Brigham and Women's Hospital Chestnut Hill Massachusetts Recruiting
UMass Memorial Medical Center Worcester Massachusetts Withdrawn
University of Michigan Hospitals Ann Arbor Michigan Recruiting
Wayne State University Detroit Michigan Recruiting
Michigan State University Department of Neurology East Lansing Michigan Recruiting
Spectrum Health Grand Rapids Michigan Recruiting
Saint Louis University Medical School St Louis Missouri Recruiting
Northeast Regional Epilepsy Group Hackensack New Jersey Recruiting
Dent Neurosciences Research Facility Amherst New York Terminated
SUNY Upstate Medical University Syracuse New York Recruiting
Five Towns Neurology Woodmere New York Withdrawn

+ 98 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05667142 on ClinicalTrials.gov ↗ ← All trials in the UK