Status:
ENROLLING_BY_INVITATION
An Open-Label Study of Azetukalner in Major Depressive Disorder
Lead Sponsor:
Xenon Pharmaceuticals Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an anteceden...
Eligibility Criteria
Inclusion
- Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD.
- 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.
- Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
Exclusion
- Participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study.
- Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
- Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
- 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.
- Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug.
- Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
- Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
Key Trial Info
Start Date :
March 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2027
Estimated Enrollment :
460 Patients enrolled
Trial Details
Trial ID
NCT06922110
Start Date
March 18 2025
End Date
March 1 2027
Last Update
September 9 2025
Active Locations (24)
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1
Ima Clinical Research - Phoenix
Phoenix, Arizona, United States, 85012
2
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
3
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
4
Excell Research Inc.
Oceanside, California, United States, 92056