A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Major Depressive Disorder
In brief
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)
Key facts
- Study ID
- NCT07076407
- Run by
- Xenon Pharmaceuticals Inc.
- People needed
- 450
- Starts
- 2025-07-08
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Hospital Universitari Vall D'Hebron — Barcelona, Spain (enrolling)
- University of Alabama at Birmingham, Huntsville Regional Medical Campus — Huntsville, Alabama, United States (enrolling)
- Pillar Clinical Research — Bentonville, Arkansas, United States (enrolling)
- SanRo Clinical Research Group — Bryant, Arkansas, United States (enrolling)
- Clinical Innovations Inc — Bellflower, California, United States (enrolling)
- Center for Neurohealth — La Jolla, California, United States (enrolling)
- Artemis Institute for Clinical Research — San Diego, California, United States (enrolling)
- California Neuroscience Research — Sherman Oaks, California, United States (enrolling)
- Dana Ignjatovićová, spol. s r.o — Banská Bystrica, Slovakia (enrolling)
- Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas — Liptovský Mikuláš, Slovakia (enrolling)
- Institute of Living — Hartford, Connecticut, United States (enrolling)
- Gulfcoast Clinical Research Center — Fort Myers, Florida, United States (enrolling)
- Sarkis Clinical Trials — Gainesville, Florida, United States (enrolling)
- Equipath Health and Research Tampa Bay, Llc — Riverview, Florida, United States (enrolling)
- Delricht Research — Atlanta, Georgia, United States (enrolling)
- Emory University Brain Health Center — Atlanta, Georgia, United States (enrolling)
- Advanced Quality Medical Research — Orland Park, Illinois, United States (enrolling)
- Smart Trials, LLC — Jefferson, Louisiana, United States (enrolling)
- Pharmasite Research Inc. — Baltimore, Maryland, United States (enrolling)
- Adams Clinical Boston — Boston, Massachusetts, United States (enrolling)
- Activmed Practices & Research, Llc - Methuen — Methuen, Massachusetts, United States (enrolling)
- Adams Clinical Watertown — Watertown, Massachusetts, United States (enrolling)
- Vitalix Clinical, Inc — Worcester, Massachusetts, United States (enrolling)
- Psychiatric Care and Research Center — O'Fallon, Missouri, United States (enrolling)
- St. Charles Psychiatric Associates - Midwest Research Group — Saint Charles, Missouri, United States (enrolling)
Full record on ClinicalTrials.gov
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