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Clinical Trial Summary

The X-TOLE3 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05716100
Study type Interventional
Source Xenon Pharmaceuticals Inc.
Contact Xenon Medical Affairs
Phone 1-604-484-3300
Email XenonCares@xenon-pharma.com
Status Recruiting
Phase Phase 3
Start date May 9, 2023
Completion date December 2025

See also
  Status Clinical Trial Phase
Recruiting NCT05614063 - A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures Phase 3
Completed NCT04836559 - A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy Phase 2
Not yet recruiting NCT06377930 - Study Evaluating the Safety and Efficacy of RAP-219 in Adult Participants With Refractory Focal Epilepsy Phase 2
Terminated NCT05473442 - Study of EQU-001 for Uncontrolled Focal Onset Seizures Phase 2