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A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder
NCT06775379 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Xenon Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06775379 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Arkansas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06775379?
The interventions under investigation include: Placebo (DRUG), Azetukalner (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06775379?
This trial is sponsored by Xenon Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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