An Open-Label Study of Azetukalner in Major Depressive Disorder

Last updated: January 30, 2026
Sponsor: Xenon Pharmaceuticals Inc.
Overall Status: Active - Enrolling

Phase

3

Condition

Affective Disorders

Depression (Major/severe)

Depression

Treatment

Azetukalner

Clinical Study ID

NCT06922110
XPF-010-D303
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participant successfully completed the treatment period of an antecedent azetukalnerPhase 3 study in MDD.

  • Participant provides written informed consent to participate in the study, is ableto 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 doseof study drug. Female participants must agree not to donate ova until 3 months afterthe last dose of study drug.

Exclusion

Exclusion Criteria:

  • Participant met any of the withdrawal criteria, or discontinued study drug early, orwas terminated early from an antecedent study.

  • Participant had any protocol deviations in an antecedent azetukalner study that, inthe opinion of the investigator, would preclude participation in this study.

  • Participant is unable to comply with study procedures or is inappropriate for thestudy, as judged by the investigator.

  • Participant has any medical condition, personal circumstance, or ongoing AE (from anantecedent study) that, in the opinion of the investigator, exposes the participantto unacceptable risk by participating in the study or prevents adherence to theprotocol.

  • Female participant who is pregnant, breastfeeding, or planning to become pregnantwithin 3 months after the last dose of study drug.

  • Participant is planning to enter a clinical study with a different investigationaldrug or planning to use any experimental device for treatment of any medicalcondition 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 behavioror is considered to be an imminent danger to themself or others, as determined bythe C-SSRS or in the opinion of the investigator.

Study Design

Total Participants: 460
Treatment Group(s): 1
Primary Treatment: Azetukalner
Phase: 3
Study Start date:
March 18, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Ima Clinical Research - Phoenix

    Phoenix, Arizona 85012
    United States

    Site Not Available

  • Ima Clinical Research - Phoenix

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Site Not Available

  • Sanro Clinical Research Group, Llc

    Bryant 4103448, Arkansas 4099753 72022
    United States

    Site Not Available

  • Woodland International Research Group

    Little Rock 4119403, Arkansas 4099753 72211
    United States

    Site Not Available

  • Woodland Research Northwest

    Rogers 4128894, Arkansas 4099753 72758
    United States

    Site Not Available

  • Atp Clinical Research

    Orange, California 92866
    United States

    Site Not Available

  • Nrc Research Institute

    Orange, California 92868
    United States

    Site Not Available

  • Cenexel Cns - Torrance

    Torrance, California 90501
    United States

    Site Not Available

  • Calneuro Research Group, Inc.

    Los Angeles 5368361, California 5332921 90025
    United States

    Site Not Available

  • Excell Research Inc.

    Oceanside 5378771, California 5332921 92056
    United States

    Site Not Available

  • Atp Clinical Research

    Orange 5379513, California 5332921 92866
    United States

    Site Not Available

  • Nrc Research Institute

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Artemis Institute For Clinical Research - San Diego

    San Diego 5391811, California 5332921 92123
    United States

    Site Not Available

  • Cenexel Cnr - Sherman Oaks

    Sherman Oaks 5395244, California 5332921 91403-2131
    United States

    Site Not Available

  • Cenexel Cns - Torrance

    Torrance 5403022, California 5332921 90501
    United States

    Site Not Available

  • Pacific Clinical Research Management

    Upland 5404915, California 5332921 91786
    United States

    Site Not Available

  • Sunwise Clinical Research

    Walnut Creek 5406990, California 5332921 94596
    United States

    Site Not Available

  • Pharmasouth Research

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc. - Jacksonville

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Harmony Clinical Research Inc

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Panhandle Research and Medical Clinic

    Pensacola, Florida 32502
    United States

    Site Not Available

  • Pharmasouth Research

    Coral Gables 4151871, Florida 4155751 33146
    United States

    Site Not Available

  • Cns Clinical Research - Coral Springs

    Coral Springs 4151909, Florida 4155751 33067
    United States

    Site Not Available

  • Gulfcoast Clinical Research Center

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Neoclinical Research

    Hialeah 4158476, Florida 4155751 33016
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc. - Jacksonville

    Jacksonville 4160021, Florida 4155751 32256
    United States

    Site Not Available

  • Accel Research Sites - St. Petersburg-Largo

    Largo 4161580, Florida 4155751 33777
    United States

    Site Not Available

  • Harmony Clinical Research Inc

    North Miami Beach 4166233, Florida 4155751 33162
    United States

    Site Not Available

  • Clinical Neuroscience Solutions Inc. - Orlando

    Orlando 4167147, Florida 4155751 32801
    United States

    Site Not Available

  • Combined Research Orlando Phase I-Iv

    Orlando 4167147, Florida 4155751 32807
    United States

    Site Not Available

  • Panhandle Research and Medical Clinic

    Pensacola 4168228, Florida 4155751 32502
    United States

    Site Not Available

  • Advanced Discovery Research, Llc

    Atlanta 4180439, Georgia 4197000 30318
    United States

    Site Not Available

  • DelRicht Research

    Atlanta 4180439, Georgia 4197000 30329
    United States

    Site Not Available

  • Synexus - Atlanta

    Atlanta 4180439, Georgia 4197000 30328
    United States

    Site Not Available

  • Cenexel Iresearch - Atlanta

    Decatur 4191124, Georgia 4197000 30030
    United States

    Site Not Available

  • Psych Atlanta, Pc

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Cenexel Iresearch - Savannah

    Savannah 4221552, Georgia 4197000 31405
    United States

    Site Not Available

  • Chicago Research Center Inc.

    Chicago, Illinois 60634
    United States

    Site Not Available

  • Chicago Research Center Inc.

    Chicago 4887398, Illinois 4896861 60634
    United States

    Site Not Available

  • Advanced Quality Medical Research, LLC

    Orland Park 4904937, Illinois 4896861 60462
    United States

    Site Not Available

  • Adams Clinical - Boston

    Boston 4930956, Massachusetts 6254926 02116
    United States

    Site Not Available

  • Boston Clinical Trials Llc

    Boston 4930956, Massachusetts 6254926 02131
    United States

    Site Not Available

  • Elixia MA, LLC

    Springfield 4951788, Massachusetts 6254926 01103
    United States

    Site Not Available

  • Adams Clinical - Watertown

    Watertown 4954611, Massachusetts 6254926 02472
    United States

    Site Not Available

  • Psychiatric Care and Research Center

    O'Fallon 4401242, Missouri 4398678 63368
    United States

    Site Not Available

  • Ima Clinical Research - Las Vegas

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • Redbird Research

    Las Vegas 5506956, Nevada 5509151 89119
    United States

    Site Not Available

  • Center For Emotional Fitness

    Cherry Hill 4501198, New Jersey 5101760 08002
    United States

    Site Not Available

  • Bio Behavioral Health

    Toms River 4504476, New Jersey 5101760 08755
    United States

    Site Not Available

  • Integrative Clinical Trials, Llc

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Integrative Clinical Trials, Llc

    Brooklyn 5110302, New York 5128638 11229
    United States

    Site Not Available

  • Richmond Behavioral Associates

    Staten Island 5139568, New York 5128638 10314
    United States

    Site Not Available

  • New Hope Clinical Research

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • Insight Clinical Trials Llc

    Independence 5158404, Ohio 5165418 44131
    United States

    Site Not Available

  • Lehigh Center For Clinical Research

    Allentown 5178127, Pennsylvania 6254927 18103
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis 4641239, Tennessee 4662168 38119
    United States

    Site Not Available

  • Delricht Research - Plano

    Plano 4719457, Texas 4736286 75024
    United States

    Site Not Available

  • Grayline Research Center

    Wichita Falls 4741752, Texas 4736286 76309
    United States

    Site Not Available

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Core Clinical Research

    Everett 5793933, Washington 5815135 98201
    United States

    Site Not Available

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