An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
← catalyst calendarNCT07217860 · readout ≤ 1,046 d
Sponsored by Xenon Pharmaceuticals Inc. (industry) · XENE — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Na · None · Treatment
Enrollment
400estimated
Sites
15
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 | 2025-10-30 | actual | When the study began enrolling |
| Primary completion | Jun 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Aug 2029 | estimated | The whole study's end, after follow-up |
| First posted | 2025-10-20 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Bipolar Depression
- Bipolar I Disorder
- Bipolar Disorder
- Bipolar II Disorder
Intervention
- Drug: Azetukalner
Primary outcome
what the primary-completion date above is the date OFSeverity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
measured From the start of treatment in the open-label extension study through 8 weeks after the last dose
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