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

Enrolling by invitation · Phase 3

Conditions studied: Bipolar Depression, Bipolar I Disorder, Bipolar Disorder, Bipolar II Disorder

In brief

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.

Key facts

Study ID

NCT07217860

Run by

Xenon Pharmaceuticals Inc.

People needed

400

Starts

2025-10-30

Expected to finish

2029-08-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant successfully completed the treatment period in a Phase 3 antecedent study evaluating azetukalner in participants with bipolar depression.
• Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
• Participant is willing to comply with the contraception requirements.

You may not qualify if…

• Participant met any of the withdrawal criteria, discontinued study drug early, or was terminated early from an antecedent study.
• Participant had any protocol deviations in an antecedent study that, in the opinion of the investigator, would preclude participation in this study.
• Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
• Participant is pregnant, breastfeeding, or planning to become pregnant.
• Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for the treatment of any medical condition during the study or within 28 days after completion of this study.
• Participant is judged by the investigator to have a significant risk for self-harm or suicidal behavior during their participation in the study or is considered to be an imminent danger to themself or others.

Where it is running

• Woodland International Research Group — Little Rock, Arkansas, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• ProScience Research Group — Culver City, California, 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
• Lehigh Center for Clinical Research — Allentown, Pennsylvania, United States
• Clinical Neuroscience Solutions Memphis — Memphis, Tennessee, United States
• Grayline Research Center — Wichita Falls, Texas, United States
• Core Clinical Research — Everett, Washington, United States

Full record on ClinicalTrials.gov

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