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A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

← catalyst calendar

NCT05614063

Sponsored by Xenon Pharmaceuticals Inc. (industry) · XENE — their whole pipeline →. With Worldwide Clinical Trials.

Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
380actual
Sites
125
Countries
Argentina, Australia, Bulgaria +15

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2022-11-18actualWhen the study began enrolling
Primary completion2026-01-12actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-02-03actualThe whole study's end, after follow-up
First posted2022-11-14actualWhen this record first appeared on the registry
Results postedWhen the sponsor posted results to the registry
Record updated2026-05-14actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Focal Onset Seizures

Interventions

  • Drug: XEN1101 — also filed as Azetukalner
  • Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF
Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
measured From baseline through to the double blind period (week 12)

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