A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age
• Body Mass Index (BMI) ≤40 kg/m2
• Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI)
• Participant's current MDE has a duration of ≥6 weeks and ≤24 months.
Locations
United States
Alabama
Harmonex Neuroscience Research
TERMINATED
Dothan
University of Alabama at Birmingham, Huntsville Regional Medical Campus
RECRUITING
Huntsville
Arkansas
Pillar Clinical Research
RECRUITING
Bentonville
SanRo Clinical Research Group
RECRUITING
Bryant
California
Clinical Innovations Inc
RECRUITING
Bellflower
Center for Neurohealth
RECRUITING
La Jolla
Artemis Institute for Clinical Research
RECRUITING
San Diego
California Neuroscience Research
RECRUITING
Sherman Oaks
Pacific Clinical Research Management Group
TERMINATED
Upland
Connecticut
Institute of Living
RECRUITING
Hartford
Florida
Gulfcoast Clinical Research Center
RECRUITING
Fort Myers
Sarkis Clinical Trials
RECRUITING
Gainesville
Equipath Health and Research Tampa Bay, Llc
RECRUITING
Riverview
Georgia
Delricht Research
RECRUITING
Atlanta
Emory University Brain Health Center
RECRUITING
Atlanta
Illinois
Advanced Quality Medical Research
RECRUITING
Orland Park
Louisiana
Smart Trials, LLC
RECRUITING
Jefferson
Massachusetts
Adams Clinical Boston
RECRUITING
Boston
Activmed Practices & Research, Llc - Methuen
RECRUITING
Methuen
Adams Clinical Watertown
RECRUITING
Watertown
Vitalix Clinical, Inc
RECRUITING
Worcester
Maryland
Pharmasite Research Inc.
RECRUITING
Baltimore
Missouri
Psychiatric Care and Research Center
RECRUITING
O'fallon
St. Charles Psychiatric Associates - Midwest Research Group
RECRUITING
Saint Charles
North Carolina
Magnolia Clinical Research, Llc
RECRUITING
Cary
New Jersey
Lumina Clinical Research Center
RECRUITING
Cherry Hill
Princeton Medical Institute
RECRUITING
Princeton
Bio Behavioral Health
RECRUITING
Toms River
New York
Bioscience Research, LLC
RECRUITING
Mount Kisco
Fieve Clinical Research, Inc.
RECRUITING
New York
IMA Clinical Research
RECRUITING
New York
Ohio
Insight Clinical Trials
RECRUITING
Independence
Oklahoma
Sooner Clinical Research
RECRUITING
Oklahoma City
Texas
Austin Clinical Trial Partners
RECRUITING
Austin
Utah
Boeson Research
RECRUITING
Provo
Other Locations
Finland
Suomen Terveystalo Oy
RECRUITING
Helsinki
Oulu Mentalcare Oy
RECRUITING
Oulu
Poland
In Vivo Sp. z.o.o.
RECRUITING
Bydgoszcz
Clinical Medical Research Sp. z o.o.
RECRUITING
Katowice
Praktyka Lekarska Malgorzata Wojtanowska-Bogacka
RECRUITING
Poznan
Specjalistyczna Praktyka Lekarska, Filip Rybakowski
RECRUITING
Poznan
Romania
Clinica Nutrimed Cercetare Sr
RECRUITING
Bucharest
Slovakia
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas
RECRUITING
Liptovský Mikuláš
Spain
Hospital Universitari Vall D'Hebron
RECRUITING
Barcelona
Contact Information
Primary
Xenon Medical Affairs
XenonCares@xenon-pharma.com
1-604-484-3300
Time Frame
Start Date: 2025-07-08
Estimated Completion Date: 2027-07
Participants
Target number of participants: 450
Treatments
Experimental: Azetukalner
Azetukalner 20 mg
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: Xenon Pharmaceuticals Inc.