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.