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An Open-Label Study of Azetukalner in Major Depressive Disorder
Sponsor: Xenon Pharmaceuticals Inc.
Summary
X-NOVA-OLE is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent Phase 3 study of azetukalner in Major Depressive Disorder (MDD).
Official title: A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of Azetukalner in Major Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
460
Start Date
2025-03-18
Completion Date
2027-03
Last Updated
2026-02-03
Healthy Volunteers
No
Conditions
Interventions
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Locations (49)
Ima Clinical Research - Phoenix
Phoenix, Arizona, United States
Sanro Clinical Research Group, Llc
Bryant, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Calneuro Research Group, Inc.
Los Angeles, California, United States
Excell Research Inc.
Oceanside, California, United States
Atp Clinical Research
Orange, California, United States
Nrc Research Institute
Orange, California, United States
Artemis Institute For Clinical Research - San Diego
San Diego, California, United States
Cenexel Cnr - Sherman Oaks
Sherman Oaks, California, United States
Cenexel Cns - Torrance
Torrance, California, United States
Pacific Clinical Research Management
Upland, California, United States
Sunwise Clinical Research
Walnut Creek, California, United States
Pharmasouth Research
Coral Gables, Florida, United States
Cns Clinical Research - Coral Springs
Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Neoclinical Research
Hialeah, Florida, United States
Clinical Neuroscience Solutions Inc. - Jacksonville
Jacksonville, Florida, United States
Accel Research Sites - St. Petersburg-Largo
Largo, Florida, United States
Harmony Clinical Research Inc
North Miami Beach, Florida, United States
Clinical Neuroscience Solutions Inc. - Orlando
Orlando, Florida, United States
Combined Research Orlando Phase I-Iv
Orlando, Florida, United States
Panhandle Research and Medical Clinic
Pensacola, Florida, United States
Advanced Discovery Research, Llc
Atlanta, Georgia, United States
Synexus - Atlanta
Atlanta, Georgia, United States
DelRicht Research
Atlanta, Georgia, United States
Cenexel Iresearch - Atlanta
Decatur, Georgia, United States
Psych Atlanta, Pc
Marietta, Georgia, United States
Cenexel Iresearch - Savannah
Savannah, Georgia, United States
Chicago Research Center Inc.
Chicago, Illinois, United States
Advanced Quality Medical Research, LLC
Orland Park, Illinois, United States
Adams Clinical - Boston
Boston, Massachusetts, United States
Boston Clinical Trials Llc
Boston, Massachusetts, United States
Elixia MA, LLC
Springfield, Massachusetts, United States
Adams Clinical - Watertown
Watertown, Massachusetts, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Ima Clinical Research - Las Vegas
Las Vegas, Nevada, United States
Redbird Research
Las Vegas, Nevada, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Integrative Clinical Trials, Llc
Brooklyn, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Insight Clinical Trials Llc
Independence, Ohio, United States
Lehigh Center For Clinical Research
Allentown, Pennsylvania, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Delricht Research - Plano
Plano, Texas, United States
Grayline Research Center
Wichita Falls, Texas, United States
Core Clinical Research
Everett, Washington, United States