drugset / Trial / NCT07217860

An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)

NCT07217860 ↗

Phase 3 Enrolling by invitation 400 enrolled Xenon Pharmaceuticals Inc.
NaSingle-groupOpen-labelTreatment

Summary

X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.

Timeline

Start
2025-10-30
Primary completion
2029-06
Completion
2029-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Azetukalner Small molecule 20 mg Oral