A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorXenon Pharmaceuticals Inc.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
XEN1101
DrugXEN1101 capsules
Placebo
DrugPlacebo capsules
Treatment groups
160 Participants
are divided into 3 treatment groupsGroup A: XEN1101 25 mg/dayExperimental treatment 1 intervention
Group B: XEN1101 15 mg/dayExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Median percent change (MPC) in monthly (28 days) PGTCS frequency
Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Time frame
Baseline through DBP (Week 12)Secondary outcomes
1
Proportion of subjects
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Time frame
Baseline through DBP (Week 12)2
Proportion of subjects
Proportion of subjects experiencing PGTCS freedom from baseline through the DBP for XEN1101 versus placebo.
Time frame
Baseline through Week 12Other outcomes
1
Incidence of adverse events
To assess the safety and tolerability of XEN1101 in subjects with PGTCS (e.g., adverse events).
Time frame
From Screening Through to 56 Days Post-Final DoseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Xenon Pharmaceuticals Inc.
Lead sponsor
Worldwide Clinical Trials
Collaborator
Source ClinicalTrials.gov