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Clinical Trials in the USA / NCT06922110
Enrolling by invitation Phase 3

An Open-Label Study of Azetukalner in Major Depressive Disorder

NCT06922110 · tracked via the Priya Life Science USA tracker
Sponsor
Xenon Pharmaceuticals Inc.
Phase
Phase 3
Started
2025-03-18
Last updated
2026-09-03

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

Azetukalner →

Azetukalner: Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 52 weeks.

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Participant successfully completed the treatment period of an antecedent azetukalner Phase 3 study in MDD. * 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 met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study. * 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.

Primary outcome measure(s)

Trial sites (71)

FacilityCityRegionStatus
Ima Clinical Research - Phoenix Phoenix Arizona
Sanro Clinical Research Group, Llc Bryant Arkansas
Woodland International Research Group Little Rock Arkansas
Woodland Research Northwest Rogers Arkansas
Cenexel Cit - Bellflower Bellflower California
Irvine Clinical Research Irvington District California
Calneuro Research Group, Inc. Los Angeles California
Excell Research Inc. Oceanside California
Atp Clinical Research Orange California
Nrc Research Institute Orange California
Artemis Institute For Clinical Research - San Diego San Diego California
Cenexel Cnr - Sherman Oaks Sherman Oaks California
Cenexel Cns - Torrance Torrance California
Pacific Clinical Research Management Upland California
Sunwise Clinical Research Walnut Creek California
Ct Clinical Research Associates Cromwell Connecticut
Institute of Living - Clinical Trials Unit Hartford Connecticut
Pharmasouth Research Coral Gables Florida
Cns Clinical Research - Coral Springs Coral Springs Florida
Gulfcoast Clinical Research Center Fort Myers Florida
Sarkis Clinical Trials Gainesville Florida
Neoclinical Research Hialeah Florida
Clinical Neuroscience Solutions Llc. Jacksonville Florida
Accel Research Sites - Lakeland Lakeland Florida
Accel Research Sites - St. Petersburg-Largo Largo Florida
Harmony Clinical Research Inc North Miami Beach Florida
Clinical Neuroscience Solutions Llc Orlando Florida
Combined Research Orlando Phase I-Iv Orlando Florida
Panhandle Research and Medical Clinic Pensacola Florida
Equipath Health and Research Tampa Bay, Llc Riverview Florida
Advanced Discovery Research, Llc Atlanta Georgia
Synexus - Atlanta Atlanta Georgia
DelRicht Research Atlanta Georgia
Cenexel Iresearch - Atlanta Decatur Georgia
Psych Atlanta, Pc Marietta Georgia
Cenexel Iresearch - Savannah Savannah Georgia
IMA Clinical Research Chicago Illinois
Advanced Quality Medical Research, LLC Orland Park Illinois
Pharmasite Research Inc. Baltimore Maryland
Adams Clinical - Boston Boston Massachusetts

+ 31 more sites — see the full list on the official registry below.

More Xenon Pharmaceuticals Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922110 on ClinicalTrials.gov ↗ ← All trials in the USA