A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
360 patients around the world
Available in Spain, Chile, Argentina, United States
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.