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ENROLLING BY INVITATION
NCT07217860
PHASE3

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

Sponsor: Xenon Pharmaceuticals Inc.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-10-30

Completion Date

2029-08

Last Updated

2026-04-03

Healthy Volunteers

No

Interventions

DRUG

Azetukalner

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

Locations (12)

Woodland International Research Group

Little Rock, Arkansas, United States

Woodland Research Northwest

Rogers, Arkansas, United States

PharmaSouth Research, LLC

Coral Gables, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Clinical Neuroscience Solutions

Orlando, Florida, United States

Synexus Clinical Research, Inc.

Atlanta, Georgia, United States

CenExel iResearch

Decatur, Georgia, United States

Denali Health Atlanta, LLC

Stone Mountain, Georgia, United States

Lumina Clinical Research Center

Cherry Hill, New Jersey, United States

Neurobehavioral Research Inc

Cedarhurst, New York, United States

Clinical Neuroscience Solutions Memphis

Memphis, Tennessee, United States

Grayline Research Center

Wichita Falls, Texas, United States