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An Open-Label Study of Azetukalner in Major Depressive Disorder

Enrolling By InvitationPhase 3

Sponsor: Xenon Pharmaceuticals Inc.

Conditions: Major Depressive Disorder

Interventions: Azetukalner

Countries: United States, Finland, Poland

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (68)

Phoenix, Arizona, United States
Bryant, Arkansas, United States
Little Rock, Arkansas, United States
Rogers, Arkansas, United States
Bellflower, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Orange, California, United States
Orange, California, United States
San Diego, California, United States
Sherman Oaks, California, United States
Torrance, California, United States
Upland, California, United States
Walnut Creek, California, United States
Cromwell, Connecticut, United States
Hartford, Connecticut, United States
Coral Gables, Florida, United States
Coral Springs, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Lakeland, Florida, United States
Largo, Florida, United States
North Miami Beach, Florida, United States
Orlando, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Riverview, Florida, United States
Atlanta, Georgia, United States
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