An Open-Label Study of Azetukalner in Major Depressive Disorder

NCT06922110 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: XPF-010-D303
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 49

Brief 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).

Conditions

Major Depressive Disorder

Keywords

Depression; Antidepressant; XEN1101; Azetukalner

Outcome Measures

Primary Outcomes (1)

• Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest

  From the start of treatment in the open-label extension study through 8 weeks after the last dose

Secondary Outcomes (5)

• Change from baseline in the Hamilton Depression Rating Scale, 17-Item (HAMD-17) total score over time

  From baseline through the active extension treatment (Week 52)

• Change from baseline in the Snaith-Hamilton Pleasure Scale (SHAPS) total score over time

  From baseline through the active extension treatment (Week 52)

• Change in the Clinical Global Impression of Severity (CGI-S) score over time

  From baseline through the active extension treatment (Week 52)

• Change from baseline in Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) total score, Q-LES-Q-SF medication and life satisfaction and contentment in item scores over time

  From baseline through the active extension treatment (Week 52)

• Change from baseline in Sheehan Disability Scale (SDS) total score and subscale scores over time

  From baseline through the active extension treatment (Week 52)

Study Arms (1)

Azetukalner 20 mg

EXPERIMENTAL

Drug: Azetukalner

Interventions

Azetukalner DRUG

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

Azetukalner 20 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xenon Pharmaceuticals Inc.: lead

Study Sites (49)

Ima Clinical Research - Phoenix

Phoenix, Arizona, 85012, United States

Location

Sanro Clinical Research Group, Llc

Bryant, Arkansas, 72022, United States

Location

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Calneuro Research Group, Inc.

Los Angeles, California, 90025, United States

Location

Excell Research Inc.

Oceanside, California, 92056, United States

Location

Atp Clinical Research

Orange, California, 92866, United States

Location

Nrc Research Institute

Orange, California, 92868, United States

Location

Artemis Institute For Clinical Research - San Diego

San Diego, California, 92123, United States

Location

Cenexel Cnr - Sherman Oaks

Sherman Oaks, California, 91403-2131, United States

Location

Cenexel Cns - Torrance

Torrance, California, 90501, United States

Location

Pacific Clinical Research Management

Upland, California, 91786, United States

Location

Sunwise Clinical Research

Walnut Creek, California, 94596, United States

Location

Pharmasouth Research

Coral Gables, Florida, 33146, United States

Location

Cns Clinical Research - Coral Springs

Coral Springs, Florida, 33067, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Neoclinical Research

Hialeah, Florida, 33016, United States

Location

Clinical Neuroscience Solutions Inc. - Jacksonville

Jacksonville, Florida, 32256, United States

Location

Accel Research Sites - St. Petersburg-Largo

Largo, Florida, 33777, United States

Location

Harmony Clinical Research Inc

North Miami Beach, Florida, 33162, United States

Location

Clinical Neuroscience Solutions Inc. - Orlando

Orlando, Florida, 32801, United States

Location

Combined Research Orlando Phase I-Iv

Orlando, Florida, 32807, United States

Location

Panhandle Research and Medical Clinic

Pensacola, Florida, 32502, United States

Location

Advanced Discovery Research, Llc

Atlanta, Georgia, 30318, United States

Location

Synexus - Atlanta

Atlanta, Georgia, 30328, United States

Location

DelRicht Research

Atlanta, Georgia, 30329, United States

Location

Cenexel Iresearch - Atlanta

Decatur, Georgia, 30030, United States

Location

Psych Atlanta, Pc

Marietta, Georgia, 30060, United States

Location

Cenexel Iresearch - Savannah

Savannah, Georgia, 31405, United States

Location

Chicago Research Center Inc.

Chicago, Illinois, 60634, United States

Location

Advanced Quality Medical Research, LLC

Orland Park, Illinois, 60462, United States

Location

Adams Clinical - Boston

Boston, Massachusetts, 02116, United States

Location

Boston Clinical Trials Llc

Boston, Massachusetts, 02131, United States

Location

Elixia MA, LLC

Springfield, Massachusetts, 01103, United States

Location

Adams Clinical - Watertown

Watertown, Massachusetts, 02472, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

Ima Clinical Research - Las Vegas

Las Vegas, Nevada, 89102, United States

Location

Redbird Research

Las Vegas, Nevada, 89119, United States

Location

Center For Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

Bio Behavioral Health

Toms River, New Jersey, 08755, United States

Location

Integrative Clinical Trials, Llc

Brooklyn, New York, 11229, United States

Location

Richmond Behavioral Associates

Staten Island, New York, 10314, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Insight Clinical Trials Llc

Independence, Ohio, 44131, United States

Location

Lehigh Center For Clinical Research

Allentown, Pennsylvania, 18103, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

Delricht Research - Plano

Plano, Texas, 75024, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 10, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 3, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (49)