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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 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.
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)
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06775379
The ClinicalTrials.gov registry entry for NCT06775379 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 375-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (20% higher). The listed sponsor is Xenon Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.