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

June 1, 2026 updated by: Xenon Pharmaceuticals Inc.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Woodland International Research Group
      • Rogers, Arkansas, United States, 72758
        • Woodland Research Northwest
    • California
      • Culver City, California, United States, 90230
        • ProScience Research Group
    • Florida
      • Coral Gables, Florida, United States, 33146
        • PharmaSouth Research, LLC
      • Jacksonville, Florida, United States, 32256
        • Clinical Neuroscience Solutions, Inc.
      • Orlando, Florida, United States, 32801
        • Clinical Neuroscience Solutions
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Synexus Clinical Research, Inc.
      • Decatur, Georgia, United States, 30030
        • CenExel iResearch
      • Stone Mountain, Georgia, United States, 30083
        • Denali Health Atlanta, LLC
    • New Jersey
      • Cherry Hill, New Jersey, United States, 92866
        • Lumina Clinical Research Center
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research Inc
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Center for Clinical Research
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions Memphis
    • Texas
      • Wichita Falls, Texas, United States, 76309
        • Grayline Research Center
    • Washington
      • Everett, Washington, United States, 98201
        • Core Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Azetukalner 20 mg
Drug: Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Time Frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose
From the start of treatment in the open-label extension study through 8 weeks after the last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
Time Frame: From baseline through the active extension treatment (Week 52)
From baseline through the active extension treatment (Week 52)
Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time
Time Frame: From baseline through the active extension treatment (Week 52)
From baseline through the active extension treatment (Week 52)
Change in Clinical Global Impression of Severity (CGI-S) score over time
Time Frame: From baseline through the active extension treatment (Week 52)
From baseline through the active extension treatment (Week 52)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xenon Pharmaceuticals Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

August 1, 2029

Study Registration Dates

First Submitted

October 14, 2025

First Submitted That Met QC Criteria

October 14, 2025

First Posted (Actual)

October 20, 2025

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XPF-010-B302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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