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An Open-label Study of XEN1101 in Epilepsy

NCT05718817 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 880

Last updated 2026-05-14

No results posted yet for this study

Summary

This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.

Conditions

  • Focal Epilepsy
  • Tonic-Clonic Seizures

Interventions

DRUG

XEN1101

XEN1101 capsules

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Xenon Pharmaceuticals Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2033-04-30
Completion
2033-06-30
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Croatia
  • Czechia
  • Finland
  • France
  • Georgia
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Mexico
  • New Zealand
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT05718817 on ClinicalTrials.gov