Last updated 19 days ago
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
160 patients around the world
Available in Spain, United States, Argentina
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 subjects diagnosed with generalized epilepsy and experiencing
probable or possible PGTCS (with or without other subtypes of generalized seizures), and
taking 1 to 3 anti-seizure medications (ASMs). Eligible subjects will be randomly
assigned 1:1 to XEN1101 or placebo: subjects aged ≥ 18 years will receive XEN1101 25 mg
or placebo, and subjects aged ≥12 years and <18 years will receive either XEN1101 15 mg,
25 mg, or placebo. Randomization will be stratified based on region, age group, and
background use of CYP3A4-inducer ASMs. Eligible subjects will have up to 9.5 weeks
durations to assess the baseline frequency of seizures, followed by a double-blind
treatment period (DBP) where subjects will receive 12 weeks of blinded treatment. During
the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an
evening meal.
Subjects who complete the 12-week DBP will have the opportunity to enroll in a separate
open-label-extension (OLE) study for continued treatment with XEN1101. Subjects who do
not enroll in the OLE will enter an 8 week post-treatment follow-up period.
Xenon Pharmaceuticals Inc.
1Research sites
160Patients around the world
This study is for people with
Seizure
Primary generalized tonic-clonic seizure
Requirements for the patient
From 12 Years
All Gender
Medical requirements
- 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 1 month prior to screening Visit 1, during screening/baseline, and throughout the DBP.Subject is able to keep accurate seizure diaries.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.Seizure diary was completed a minimum of 80% of all days, that is, ≥45 days during the last 56 days of the baseline period that preceded randomization as evidence of adequate compliance.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.
- 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.Subject has a concomitant diagnosis of 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 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, 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.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.
Sites
STAT Research - CABA
Recruiting
StudyX-ACKT
SponsorXenon Pharmaceuticals Inc.
Conditions
Primary generalized tonic-clonic seizure
Requirements
From 12 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05667142
