A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Major Depressive Disorder

In brief

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)

Key facts

Study ID

NCT06775379

Run by

Xenon Pharmaceuticals Inc.

People needed

450

Starts

2024-12-20

Expected to finish

2026-10-01

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

• Synexus - Atlanta — Atlanta, Georgia, United States (enrolling)
• Psych Atlanta, Pc — Marietta, Georgia, United States (enrolling)
• IMA Clinical Research Phoenix — Phoenix, Arizona, United States (enrolling)
• Advanced Discovery Research — Atlanta, Georgia, United States (enrolling)
• Woodland Research Northwest — Rogers, Arkansas, United States (enrolling)
• CalNeuro Research Group, Inc. — Los Angeles, California, United States (enrolling)
• Behavioral Research Specialists, Llc — Glendale, California, United States (enrolling)
• Atp Clinical Research — Orange, California, United States (enrolling)
• Nrc Research Institute — Orange, California, United States (enrolling)
• Panhandle Research and Medical Clinic — Pensacola, Florida, United States (enrolling)
• Irvine Clinical Research — Irvine, California, United States (enrolling)
• Kinetic Clinical Research, LLC — West Covina, California, United States (enrolling)
• Mountain View Clinical Research — Denver, Colorado, United States (enrolling)
• Ct Clinical Research Associates — Cromwell, Connecticut, United States (enrolling)
• CNS Clinical Research Group — Coral Springs, Florida, United States (enrolling)
• Excell Research Inc. — Oceanside, California, United States (enrolling)
• Clinical Neuroscience Solutions, Inc. — Jacksonville, Florida, United States (enrolling)
• Accel Research Sites Lakeland — Lakeland, Florida, United States (enrolling)
• Accel Research Sites - St. Petersburg-Largo — Largo, Florida, United States (enrolling)
• PharmaSouth Research — Miami, Florida, United States (enrolling)
• CenExel CNS-TO (Collaborative Neuroscience Research) — Torrance, California, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
• Clinical Neuroscience Solutions, Inc. — Orlando, Florida, United States (enrolling)
• Sunwise Clinical Research — Walnut Creek, California, United States (enrolling)
• Cenexel Iresearch - Savannah — Savannah, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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