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)
Median percent change (MPC) in monthly (28 days) PGTCS frequency — Baseline through DBP (Week 12) Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Trial sites (138)
Facility
City
Region
Status
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.
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.
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