An Open-Label Study of Azetukalner in Major Depressive Disorder

Last updated: April 8, 2025
Sponsor: Xenon Pharmaceuticals Inc.
Overall Status: Active - Enrolling

Phase

3

Condition

Depression

Mood Disorders

Affective Disorders

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

  • Chicago Research Center Inc.

    Chicago, Illinois 60634
    United States

    Site Not Available

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee 38119
    United States

    Site Not Available

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