A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Purpose

X-NOVA2 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of azetukalner as a monotherapy in adult participants diagnosed with Major Depressive Disorder (MDD)

Condition

  • Major Depressive Disorder

Eligibility

Eligible Ages
Between 18 Years and 74 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults ≥18 and ≤74 years of age and experienced their first major depressive episode (MDE) prior to 50 years of age - Body Mass Index (BMI) ≤40 kg/m2 - Meets the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition Text Revised (DSM-5-TR) criteria for current major depressive disorder and is currently in an MDE, confirmed using the Mini International Neuropsychiatric Interview (MINI) - Participant's current MDE has a duration of ≥6 weeks and ≤24 months.

Exclusion Criteria

  • Participant has a primary diagnosis of a mood disorder other than MDD. - Participant has a history of any of the following: MDD with psychotic or catatonic features; MDD with mixed features; Bipolar I or II disorder; Obsessive-compulsive disorder; Schizophrenia, primary thought disorder, or other psychotic disorder. - Participant has a current diagnosis of any of the following: MDD with seasonal pattern; Depression with peripartum or perimenopausal onset; Post traumatic stress disorder; Antisocial or borderline personality disorder (or presence of clinically significant borderline personality traits); Panic disorder and/or agoraphobia; ADHD treated with a psychostimulant, diagnosed during the current MDE, or with unstable symptoms, as judged by the investigator. - Participant has a substance (excluding tobacco) or alcohol use disorder within the 12 months prior to screening. - Participant has had an active suicidal plan/intent within the 6 months prior to screening, presence of suicidal behavior in the last 2 years, or >1 suicide attempt >24 years of age. - Participant has a history of non-suicidal self-harm behavior in the 12 months prior to screening. - Participant has used antidepressants or other prohibited medications (including benzodiazepines), within the 2 weeks (4 weeks for fluoxetine) or within a period less than 5 times the drug's half-life, whichever is longer, prior to randomization. - Participant has a history of non-response to ≥2 antidepressant drugs of adequate dose and duration in the current MDE as determined by the Antidepressant Treatment Response Questionnaire (ATRQ). - Participants with medical conditions that may interfere with the purpose or conduct of the study - Participant is pregnant, breastfeeding, or planning to become pregnant.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Azetukalner 		Azetukalner 20 mg
  • Drug: Azetukalner
    Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
    Other names:
    • XEN1101
Placebo Comparator
Placebo 		Placebo
  • Drug: Placebo
    Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Recruiting Locations

IMA Clinical Research Phoenix
Phoenix, Arizona 85012

Woodland International Research Group
Little Rock, Arkansas 72211

Woodland Research Northwest
Rogers, Arkansas 72758

Behavioral Research Specialists, Llc
Glendale, California 91206

Marvel Clinical Research
Huntington Beach, California 92647

Irvine Clinical Research
Irvine, California 92614

CalNeuro Research Group, Inc.
Los Angeles, California 90025

Excell Research Inc.
Oceanside, California 92056

Atp Clinical Research
Orange, California 92866

Nrc Research Institute
Orange, California 92868

CenExel CNS-TO (Collaborative Neuroscience Research)
Torrance, California 90504

Sunwise Clinical Research
Walnut Creek, California 94596

Ct Clinical Research Associates
Cromwell, Connecticut 06416

CNS Clinical Research Group
Coral Springs, Florida 33067

NeoClinical Research
Hialeah, Florida 33016

Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida 32256

Accel Research Sites Lakeland
Lakeland, Florida 33803

Accel Research Sites - St. Petersburg-Largo
Largo, Florida 33777

PharmaSouth Research
Miami, Florida 33165

Harmony Clinical Research Inc
North Miami Beach, Florida 33162

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801

Combined Research Orlando Phase I-Iv
Orlando, Florida 32807

Panhandle Research and Medical Clinic
Pensacola, Florida 32503

Advanced Discovery Research
Atlanta, Georgia 30318

Synexus - Atlanta
Atlanta, Georgia 30328

CenExel iResearch
Decatur, Georgia 30030

Psych Atlanta, Pc
Marietta, Georgia 30060

Cenexel Iresearch - Savannah
Savannah, Georgia 31405

Northwest Clinical Trials Inc
Boise, Idaho 83704

Chicago Research Center Inc.
Chicago, Illinois 60634

Boston Clinical Trials Llc
Boston, Massachusetts 02131

ELIXIA
Springfield, Massachusetts 01103

IMA Clinical Research Las Vegas
Las Vegas, Nevada 89102

Redbird Research
Las Vegas, Nevada 89119

IMA Clinical Research
Albuquerque, New Mexico 87109

Integrative Clinical Trials
Brooklyn, New York 11229

Richmond Behavioral Associates
Staten Island, New York 10314

New Hope Clinical Research
Charlotte, North Carolina 28211

Pahl Pharmaceutical Professionals Llc
Oklahoma City, Oklahoma 73112

Lehigh Center For Clinical Research
Allentown, Pennsylvania 18103

Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee 38119

Delricht Research - Plano
Plano, Texas 75024

Aim Trials, Llc
Plano, Texas 75093

Grayline Research Center
Wichita Falls, Texas 76309

Core Clinical Research
Everett, Washington 98201

More Details

Status
Recruiting
Sponsor
Xenon Pharmaceuticals Inc.

Study Contact

Xenon Medical Affairs
1-604-484-3300
XenonCares@xenon-pharma.com