NCT07217860
An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)
Enrolling by Invitation
PHASE3Ages 18–75InterventionalTreatmentXenon Pharmaceuticals Inc.
~400 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Azetukalner
At a glance
Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Measured over From the start of treatment in the open-label extension study through 8 weeks after the last dose
Conditions
Where it's being run
15 sites across 10 statesFlorida3
Georgia3
Arkansas2
California1
New Jersey1
New York1
Pennsylvania1
Tennessee1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interestFrom the start of treatment in the open-label extension study through 8 weeks after the last dose