drugset / Trial / NCT07172516

A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

NCT07172516 ↗

Phase 3 Recruiting 400 enrolled Xenon Pharmaceuticals Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

X-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

Timeline

Start
2025-08-08
Primary completion
2028-06
Completion
2028-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Azetukalner Small molecule 20 mg Oral