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Clinical Trials in the USA / NCT07217860
Enrolling by invitation Phase 3

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

NCT07217860 · tracked via the Priya Life Science USA tracker
Sponsor
Xenon Pharmaceuticals Inc.
Phase
Phase 3
Started
2025-10-30
Last updated
2026-09-02

Condition(s) studied

Bipolar DepressionBipolar I DisorderBipolar DisorderBipolar II Disorder

Investigational drug(s) / intervention(s)

Azetukalner

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (20)

FacilityCityRegionStatus
Woodland International Research Group Little Rock Arkansas
Woodland Research Northwest Rogers Arkansas
Clinical Innovations, Inc, dba CITrials Bellflower California
ProScience Research Group Culver City California
Clinical Innovations, Inc Riverside California
PharmaSouth Research, LLC Coral Gables Florida
Clinical Neuroscience Solutions, LLC Jacksonville Florida
Central Miami Medical Institute Miami Florida
Clinical Neuroscience Solutions, LLC Orlando Florida
Synexus Clinical Research, Inc. Atlanta Georgia
Atlanta Center for Medical Research Atlanta Georgia
CenExel iResearch Decatur Georgia
Denali Health Atlanta, LLC Stone Mountain Georgia
Advanced Quality Medical Research Orland Park Illinois
Lumina Clinical Research Center Cherry Hill New Jersey
Neurobehavioral Research Inc Cedarhurst New York
Lehigh Center for Clinical Research Allentown Pennsylvania
Clinical Neuroscience Solutions, LLC Memphis Tennessee
Grayline Research Center Wichita Falls Texas
Core Clinical Research Everett Washington

More Xenon Pharmaceuticals Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07217860 on ClinicalTrials.gov ↗ ← All trials in the USA