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

NCT07217860 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: XPF-010-B302
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

Bipolar; XEN1101; Azetukalner

Outcome Measures

Primary Outcomes (1)

• Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest

  From the start of treatment in the open-label extension study through 8 weeks after the last dose

Secondary Outcomes (3)

• Change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score over time

  From baseline through the active extension treatment (Week 52)

• Change in Clinical Global Impression of Severity (CGI-S) score over time

  From baseline through the active extension treatment (Week 52)

• Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time

  From baseline through the active extension treatment (Week 52)

Study Arms (1)

Azetukalner 20 mg

EXPERIMENTAL

Drug: Azetukalner

Interventions

Azetukalner DRUG

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

Azetukalner 20 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (10)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

Location

Clinical Neuroscience Solutions

Orlando, Florida, 32801, United States

Location

CenExel iResearch

Decatur, Georgia, 30030, United States

Location

Denali Health Atlanta, LLC

Stone Mountain, Georgia, 30083, United States

Location

Lumina Clinical Research Center

Cherry Hill, New Jersey, 92866, United States

Location

Neurobehavioral Research Inc

Cedarhurst, New York, 11516, United States

Location

Clinical Neuroscience Solutions Memphis

Memphis, Tennessee, 38119, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Related Links

• A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression) (X-CEED)

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)