An Open-Label Study of Azetukalner in Major Depressive Disorder

Launched by XENON PHARMACEUTICALS INC. · Apr 8, 2025

Keywords

ClinConnect Summary

X-NOVA-OLE is a long-term, open-label study (meaning everyone knows the treatment) to see if azetukalner, used by itself (no other antidepressants), is safe, tolerable, and helpful for adults with Major Depressive Disorder who finished a previous azetukalner Phase 3 trial. Participants take azetukalner 20 mg once daily with food for about 52 weeks. The study will closely monitor safety, including any side effects or serious problems, and will also measure whether depression symptoms and quality of life improve over time, with results tracked up to 8 weeks after the last dose.

To join, adults 18 and older who completed the earlier azetukalner trial and gave informed consent can be invited, and they must follow study rules (including contraception requirements). Exclusions include being at high risk for self-harm, inability to follow procedures, pregnancy or planning pregnancy, recent withdrawal from a previous azetukalner study, or other safety concerns identified by the investigator. The study is conducted at multiple sites across the United States, with about 460 participants expected. Key outcomes include standard mood and functioning scales (like HAM-D-17, SHAPS, CGI-S, Q-LES-Q-SF, and SDS) to understand how long-term use of azetukalner affects symptoms, daily life, and overall well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.