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NCT06775379 · ClinicalTrials.gov registry record · Phase 3
A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Xenon Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT06775379: Recruiting Phase 3 study of Major Depressive Disorder, sponsored by Xenon Pharmaceuticals.
NCT06775379 is a Phase 3 study of Major Depressive Disorder that is actively recruiting participants, run by Xenon Pharmaceuticals. The registered enrollment target is 450 participants, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06775379, a Phase 3 study of Major Depressive Disorder, is actively recruiting participants, sponsored by Xenon Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
X-NOVA2 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)
Primary Outcome
The HAMD-17 consists of 17 items that are used to rate the severity of depression symptoms. Each item is scored in a range of 0 to 2 points or 0 to 4 points, with higher scores indicating a greater degree of depression. The score for each item is summed to compute a total score, which ranges from 0 to 52 points.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Azetukalner
Study Locations (20)
California
- Behavioral Research Specialists, Llc - Glendale
- Marvel Clinical Research - Huntington Beach
- Irvine Clinical Research - Irvine
- CalNeuro Research Group, Inc. - Los Angeles
- Excell Research Inc. - Oceanside
- Atp Clinical Research - Orange
- Nrc Research Institute - Orange
- CenExel CNS-TO (Collaborative Neuroscience Research) - Torrance
- Sunwise Clinical Research - Walnut Creek
Florida
- CNS Clinical Research Group - Coral Springs
- NeoClinical Research - Hialeah
- Clinical Neuroscience Solutions, Inc. - Jacksonville
- Accel Research Sites Lakeland - Lakeland
- Accel Research Sites - St. Petersburg-Largo - Largo
- PharmaSouth Research - Miami
- Quantum Clinical Trials - Miami Beach
Arkansas
- Woodland International Research Group - Little Rock
- Woodland Research Northwest - Rogers
Arizona
- IMA Clinical Research Phoenix - Phoenix
Connecticut
- Ct Clinical Research Associates - Cromwell
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2024-12-20 |
| Est. Completion | 2026-10 |
| Phase | Phase 3 |
What NCT06775379 shows while recruiting
NCT06775379 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06775379 names 20 study sites across 5 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06775379 about?
NCT06775379 is a clinical study titled "A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder". X-NOVA2 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)
What is the current status of trial NCT06775379?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2024-12-20. Estimated completion is 2026-10.
What conditions does trial NCT06775379 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT06775379?
The interventions under investigation include: Placebo (DRUG), Azetukalner (DRUG).
Who is sponsoring clinical trial NCT06775379?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06775379 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06775379's enrollment target sits among peer trials
450 42nd of 282 higher than 239 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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