Major Depressive Disorder / Azetukalner · Phase 3 Trial

A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

ClinicalTrials.gov · September 8, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

X-NOVA3 is a Phase 3 randomized controlled trial of azetukalner in major depressive disorder that is currently recruiting participants. No efficacy or safety results have been posted in this registry record, so no clinical evidence on the drug's effect can be drawn from this source.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Major Depressive Disorder; age from 18 Years; to 74 Years. Intervention: Azetukalner. Compared with: Placebo — Placebo Comparator. n = 450. 50 sites across 7 countries.

Key findings

Safety

No efficacy, safety, or tolerability data are available from this source.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a trial registration with no results posted; the study is currently recruiting and has not yet reported efficacy or safety data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6 (assessed at Baseline to Week 6)

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationMajor Depressive Disorder; age from 18 Years; to 74 Years

Sample size450

InterventionAzetukalner

ComparatorPlacebo — Placebo Comparator

Setting50 sites across 7 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment450

Study phasePhase 3

Primary outcome measureChange from baseline in Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6

Follow-up durationWeek 6

Caveats

This is a registry record only; no results have been reported.
Recruitment status is ongoing; trial is not complete.
No efficacy, safety, or tolerability data are available from this source.
Study eligibility criteria and baseline characteristics are not provided in the registry excerpt.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Phase 3, multicenter, randomized, double-blind, placebo-controlled design.

Directness

strong

Primary outcome is HAMD-17 change, a direct measure of depression severity.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry entry.

Risk of bias

moderate

Double-blind, placebo-controlled design reduces bias; blinding methods not detailed in registry.

Sample adequacy

moderate

Estimated 450 participants enrolled; adequacy for primary endpoint not justified in registry.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07076407). This is a study registration, not published results. Lead sponsor: Xenon Pharmaceuticals Inc.. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 450 participants (ESTIMATED). Conditions: Major Depressive Disorder. Interventions: DRUG: Azetukalner; DRUG: Placebo. Primary outcome measures: Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6 , Baseline to Week 6. Brief summary: X-NOVA3 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Xenon PharmaceuticalsNCT07076407Major Depressive DisorderAzetukalner