An Open-Label Study of Azetukalner in Major Depressive Disorder
NCT ID: NCT06922110
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
PHASE3
460 participants
INTERVENTIONAL
2025-03-18
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Azetukalner 20 mg
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Interventions
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Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.
Eligibility Criteria
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Inclusion Criteria
* Participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them.
* Participant is willing to comply with the contraception requirements.
* Male participants must agree not to donate sperm until 3 months after the last dose of study drug. Female participants must agree not to donate ova until 3 months after the last dose of study drug.
Exclusion Criteria
* Participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study.
* Participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator.
* Participant has any medical condition, personal circumstance, or ongoing AE (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol.
* Female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug.
* Participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study.
* Participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the C-SSRS or in the opinion of the investigator.
18 Years
ALL
No
Sponsors
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Xenon Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Locations
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Ima Clinical Research - Phoenix
Phoenix, Arizona, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest
Rogers, Arkansas, United States
Excell Research Inc.
Oceanside, California, United States
Atp Clinical Research
Orange, California, United States
Nrc Research Institute
Orange, California, United States
Cenexel Cns - Torrance
Torrance, California, United States
Pharmasouth Research
Coral Gables, 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
Combined Research Orlando Phase I-Iv
Orlando, Florida, United States
Panhandle Research and Medical Clinic
Pensacola, Florida, United States
Cenexel Iresearch - Atlanta
Decatur, Georgia, United States
Psych Atlanta, Pc
Marietta, Georgia, United States
Chicago Research Center Inc.
Chicago, Illinois, United States
Ima Clinical Research - Las Vegas
Las Vegas, Nevada, United States
Redbird Research
Las Vegas, Nevada, 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
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Other Identifiers
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XPF-010-D303
Identifier Type: -
Identifier Source: org_study_id
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