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 (9) 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
California
California Neuroscience Research
RECRUITING
Sherman Oaks
Georgia
Delricht Research
RECRUITING
Atlanta
Illinois
Advanced Quality Medical Research
RECRUITING
Orland Park
Massachusetts
Activmed Practices & Research, Llc - Methuen
RECRUITING
Methuen
Maryland
Pharmasite Research Inc.
RECRUITING
Baltimore
Missouri
Psychiatric Care and Research Center
RECRUITING
O'fallon
North Carolina
Magnolia Clinical Research, Llc
RECRUITING
Cary
New Jersey
Center for Emotional Fitness
RECRUITING
Cherry Hill
Bio Behavioral Health
RECRUITING
Toms River
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.