RecruitingPhase 3NCT07076407

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

A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder


Sponsor

Xenon Pharmaceuticals Inc.

Enrollment

450 participants

Start Date

Jul 8, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study (called X-NOVA3) is testing a drug called azetukalner versus a placebo (inactive pill) for adults with major depressive disorder (MDD) who are currently in a depressive episode. **You may be eligible if...** - You are between 18 and 74 years old - You have a diagnosis of major depressive disorder and are currently in a depressive episode - Your first major depressive episode started before you were 50 years old - Your current episode has lasted at least 6 weeks but no longer than 24 months - Your BMI is 40 or below **You may NOT be eligible if...** - Your primary diagnosis is a different mood disorder (not MDD) - You have a history of bipolar disorder, psychosis, schizophrenia, catatonia, OCD, or certain other psychiatric conditions - Your MDD has psychotic or mixed features Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzetukalner

Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks

DRUGPlacebo

Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks


Locations(42)

Harmonex Neuroscience Research

Dothan, Alabama, United States

University of Alabama at Birmingham, Huntsville Regional Medical Campus

Huntsville, Alabama, United States

Pillar Clinical Research

Bentonville, Arkansas, United States

SanRo Clinical Research Group

Bryant, Arkansas, United States

Clinical Innovations Inc

Bellflower, California, United States

Center for Neurohealth

La Jolla, California, United States

Artemis Institute for Clinical Research

San Diego, California, United States

California Neuroscience Research

Sherman Oaks, California, United States

Pacific Clinical Research Management Group

Upland, California, United States

Institute of Living

Hartford, Connecticut, United States

Gulfcoast Clinical Research Center

Fort Myers, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Equipath Health and Research Tampa Bay, Llc

Riverview, Florida, United States

Delricht Research

Atlanta, Georgia, United States

Emory University Brain Health Center

Atlanta, Georgia, United States

Advanced Quality Medical Research

Orland Park, Illinois, United States

Smart Trials, LLC

Jefferson, Louisiana, United States

Pharmasite Research Inc.

Baltimore, Maryland, United States

Adams Clinical Boston

Boston, Massachusetts, United States

Activmed Practices & Research, Llc - Methuen

Methuen, Massachusetts, United States

Adams Clinical Watertown

Watertown, Massachusetts, United States

Vitalix Clinical, Inc

Worcester, Massachusetts, United States

Psychiatric Care and Research Center

O'Fallon, Missouri, United States

St. Charles Psychiatric Associates - Midwest Research Group

Saint Charles, Missouri, United States

Lumina Clinical Research Center

Cherry Hill, New Jersey, United States

Princeton Medical Institute

Princeton, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Bioscience Research, LLC

Mount Kisco, New York, United States

Fieve Clinical Research, Inc.

New York, New York, United States

IMA Clinical Research

New York, New York, United States

Magnolia Clinical Research, Llc

Cary, North Carolina, United States

Insight Clinical Trials

Independence, Ohio, United States

Sooner Clinical Research

Oklahoma City, Oklahoma, United States

Austin Clinical Trial Partners

Austin, Texas, United States

Boeson Research

Provo, Utah, United States

Suomen Terveystalo Oy

Helsinki, Finland

Oulu Mentalcare Oy

Oulu, Finland

Clinical Medical Research Sp. z o.o.

Katowice, Poland

Praktyka Lekarska Malgorzata Wojtanowska-Bogacka

Poznan, Poland

Specjalistyczna Praktyka Lekarska, Filip Rybakowski

Poznan, Poland

Clinica Nutrimed Cercetare Sr

Bucharest, Romania

Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas

Liptovský Mikuláš, Slovakia

View Full Details on ClinicalTrials.gov

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NCT07076407


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