A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
← catalyst calendarNCT05716100 · readout ≤ 73 d
Sponsored by Xenon Pharmaceuticals Inc. (industry) · XENE — their whole pipeline →. With Worldwide Clinical Trials.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
360estimated
Sites
95
Countries
Argentina, Australia, Austria +17
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| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-05-09 | actual | When the study began enrolling |
| Primary completion | Oct 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-08 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-14 | actual | The 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 OFMedian percent change (MPC) in 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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