A Phase 3 interventional study of Azetukalner in Major Depressive Disorder, sponsored by Xenon Pharmaceuticals Inc.. Enrolling by invitation at 71 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Xenon Pharmaceuticals Inc. · Phase 3, Interventional, and Treatment
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 antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).
2,741 studies on the registry are indexed under Depressive Disorder, Major; 559 are open to participants now.
This study's planned enrollment of 460 is above the median of 80 across 2,283 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Xenon Pharmaceuticals Inc. is the lead sponsor of 23 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest
Time frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose
Change from baseline in the Hamilton Depression Rating Scale, 17-Item (HAMD-17) total score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change in the Clinical Global Impression of Severity (CGI-S) score over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) total score, Q-LES-Q-SF medication and life satisfaction and contentment in item scores over time
Time frame: From baseline through the active extension treatment (Week 52)
Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores over time
Time frame: From baseline through the active extension treatment (Week 52)
Plan to share: No
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Xenon Pharmaceuticals Inc.