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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)

NCT05716100 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-05-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

XEN1101

XEN1101 Capsules

DRUG

Placebo

Placebo Capsules

Sponsors & Collaborators

Principal Investigators

  • Xenon Medical Director · Xenon Pharmaceuticals Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-09
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Chile
  • Croatia
  • Czechia
  • Finland
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05716100 on ClinicalTrials.gov