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 (51) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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)
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
Arkansas
Woodland International Research Group
RECRUITING
Little Rock
Woodland Research Northwest
RECRUITING
Rogers
Arizona
IMA Clinical Research Phoenix
RECRUITING
Phoenix
California
Behavioral Research Specialists, Llc
RECRUITING
Glendale
Marvel Clinical Research
WITHDRAWN
Huntington Beach
Irvine Clinical Research
RECRUITING
Irvine
CalNeuro Research Group, Inc.
RECRUITING
Los Angeles
Excell Research Inc.
RECRUITING
Oceanside
Atp Clinical Research
RECRUITING
Orange
Nrc Research Institute
RECRUITING
Orange
CenExel CNS-TO (Collaborative Neuroscience Research)
RECRUITING
Torrance
Sunwise Clinical Research
RECRUITING
Walnut Creek
Kinetic Clinical Research, LLC
RECRUITING
West Covina
Colorado
Mountain View Clinical Research
RECRUITING
Denver
Connecticut
Ct Clinical Research Associates
RECRUITING
Cromwell
Florida
CNS Clinical Research Group
RECRUITING
Coral Springs
NeoClinical Research
ACTIVE_NOT_RECRUITING
Hialeah
Clinical Neuroscience Solutions, Inc.
RECRUITING
Jacksonville
Accel Research Sites Lakeland
RECRUITING
Lakeland
Accel Research Sites - St. Petersburg-Largo
RECRUITING
Largo
PharmaSouth Research
RECRUITING
Miami
Quantum Clinical Trials
TERMINATED
Miami Beach
Harmony Clinical Research Inc
ACTIVE_NOT_RECRUITING
North Miami Beach
Clinical Neuroscience Solutions, Inc.
RECRUITING
Orlando
Combined Research Orlando Phase I-Iv
ACTIVE_NOT_RECRUITING
Orlando
Panhandle Research and Medical Clinic
RECRUITING
Pensacola
Georgia
Advanced Discovery Research
RECRUITING
Atlanta
Synexus - Atlanta
RECRUITING
Atlanta
CenExel iResearch
ACTIVE_NOT_RECRUITING
Decatur
Psych Atlanta, Pc
RECRUITING
Marietta
Cenexel Iresearch - Savannah
RECRUITING
Savannah
Idaho
Northwest Clinical Trials Inc
RECRUITING
Boise
Illinois
IMA Clinical Research
ACTIVE_NOT_RECRUITING
Chicago
Massachusetts
Boston Clinical Trials Llc
RECRUITING
Boston
ELIXIA
RECRUITING
Springfield
Missouri
Tekton Research
RECRUITING
St Louis
North Carolina
New Hope Clinical Research
RECRUITING
Charlotte
New Mexico
IMA Clinical Research
RECRUITING
Albuquerque
Nevada
IMA Clinical Research Las Vegas
RECRUITING
Las Vegas
Redbird Research
ACTIVE_NOT_RECRUITING
Las Vegas
New York
Integrative Clinical Trials
RECRUITING
Brooklyn
Richmond Behavioral Associates
RECRUITING
Staten Island
Ohio
Neuro-Behavioral Clinical Research
RECRUITING
North Canton
Oklahoma
Pahl Pharmaceutical Professionals Llc
RECRUITING
Oklahoma City
Pennsylvania
Lehigh Center For Clinical Research
RECRUITING
Allentown
Adams Clinical - Philadelphia
RECRUITING
Philadelphia
Tennessee
Clinical Neuroscience Solutions, Inc.
RECRUITING
Memphis
Texas
Aim Trials, Llc
RECRUITING
Plano
Delricht Research - Plano
RECRUITING
Plano
Grayline Research Center
RECRUITING
Wichita Falls
Washington
Core Clinical Research
RECRUITING
Everett
Contact Information
Primary
Xenon Medical Affairs
XenonCares@xenon-pharma.com
1-604-484-3300
Time Frame
Start Date: 2024-12-20
Estimated Completion Date: 2026-10
Participants
Target number of participants: 450
Treatments
Experimental: Azetukalner
Azetukalner 20 mg
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: Xenon Pharmaceuticals Inc.