The X-TOLE2 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
Approximately 360 subjects will be randomized in a blinded manner to one of two active treatment groups or placebo in a 1:1:1 fashion (XEN1101 25 mg : 15 mg : Placebo). Eligible subjects will have up to 9.5 weeks of baseline to assess frequency of seizures, followed by 12 weeks of blinded treatment. In order to be included in the study, subjects must be treated with a stable dose of 1 to 3 allowable antiseizure medications (ASMs) for at least one month prior to screening, during baseline, and throughout the double-blind treatment period (DBP) of the study. 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 qualify and enroll in a separate open-label extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter a 8-week post treatment follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Time frame: From baseline through to the double blind period (week 12)
Proportion of subjects experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline through the DBP for XEN1101 versus placebo.
Time frame: From baseline through to the double blind period (week 12)
MPC in weekly (7 days) focal seizure frequency from baseline to Week 1 for XEN1101 versus placebo.
Time frame: From baseline through to the week 1
Proportion of subjects experiencing "at least much improved" (including "much" and "very much improved") in Patient Global Impression of Change (PGI-C).
Time frame: From baseline through to the double blind period (week 12)
To assess adverse events as criteria for safety and tolerability of XEN1101
Time frame: From screening through to 56 days post-final dose.
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Strada Patient Care Center
Mobile, Alabama, United States
Xenoscience
Phoenix, Arizona, United States
University of Arizona, Health Sciences Center
Tucson, Arizona, United States
Clinical Trials, Inc
Little Rock, Arkansas, United States
Brain Science Research Institute
Los Angeles, California, United States
University of California, David Clinical & Translational Science Center Clinical Research (CCRC)
Sacramento, California, United States
Anschutz Health Sciences
Aurora, Colorado, United States
Serenity Research
Miami, Florida, United States
Research Institute of Orlando, LLC
Orlando, Florida, United States
Panhandle Research & Medical Clinic
Pensacola, Florida, United States
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