NCT07217860

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

A Multicenter, Long-term, Open-Label, Safety, Tolerability, and Efficacy Study of Azetukalner in Bipolar I or II Depression

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Xenon Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Depression
• Bipolar I Disorder
• Bipolar Disorder
• Bipolar II Disorder

Interventions

Type	Name	Description
DRUG	Azetukalner	Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.

Timeline

• Start date: 2025-10-30
• Primary completion: 2029-06-01
• Completion: 2029-08-01
• First posted: 2025-10-20
• Last updated: 2026-04-03

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study