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An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Sponsor: Xenon Pharmaceuticals Inc.
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
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