A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
← catalyst calendarNCT06775379 · readout ≤ 12 d
Sponsored by Xenon Pharmaceuticals Inc. (industry) · XENE — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
450estimated
Sites
51
Country
United States
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 | 2024-12-20 | actual | When the study began enrolling |
| Primary completion | Aug 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Oct 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Major Depressive Disorder
Interventions
- Drug: Azetukalner — also filed as XEN1101
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6
measured Baseline to Week 6
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