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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

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 5308655, Arizona 5551752 85012

Woodland International Research Group
Little Rock 4119403, Arkansas 4099753 72211

Woodland Research Northwest
Rogers 4128894, Arkansas 4099753 72758

Behavioral Research Specialists, Llc
Glendale 5352423, California 5332921 91206

Marvel Clinical Research
Huntington Beach 5358705, California 5332921 92647

Irvine Clinical Research
Irvine 5359777, California 5332921 92614

CalNeuro Research Group, Inc.
Los Angeles 5368361, California 5332921 90025

Excell Research Inc.
Oceanside 5378771, California 5332921 92056

Atp Clinical Research
Orange 5379513, California 5332921 92866

Nrc Research Institute
Orange 5379513, California 5332921 92868

CenExel CNS-TO (Collaborative Neuroscience Research)
Torrance 5403022, California 5332921 90504

Sunwise Clinical Research
Walnut Creek 5406990, California 5332921 94596

Ct Clinical Research Associates
Cromwell 4832121, Connecticut 4831725 06416

CNS Clinical Research Group
Coral Springs 4151909, Florida 4155751 33067

NeoClinical Research
Hialeah 4158476, Florida 4155751 33016

Clinical Neuroscience Solutions, Inc.
Jacksonville 4160021, Florida 4155751 32256

Accel Research Sites Lakeland
Lakeland 4161438, Florida 4155751 33803

Accel Research Sites - St. Petersburg-Largo
Largo 4161580, Florida 4155751 33777

PharmaSouth Research
Miami 4164138, Florida 4155751 33165

Harmony Clinical Research Inc
North Miami Beach 4166233, Florida 4155751 33162

Clinical Neuroscience Solutions, Inc.
Orlando 4167147, Florida 4155751 32801

Combined Research Orlando Phase I-Iv
Orlando 4167147, Florida 4155751 32807

Panhandle Research and Medical Clinic
Pensacola 4168228, Florida 4155751 32503

Advanced Discovery Research
Atlanta 4180439, Georgia 4197000 30318

Synexus - Atlanta
Atlanta 4180439, Georgia 4197000 30328

CenExel iResearch
Decatur 4191124, Georgia 4197000 30030

Psych Atlanta, Pc
Marietta 4207783, Georgia 4197000 30060

Cenexel Iresearch - Savannah
Savannah 4221552, Georgia 4197000 31405

Northwest Clinical Trials Inc
Boise 5586437, Idaho 5596512 83704

Chicago Research Center Inc.
Chicago 4887398, Illinois 4896861 60634

Boston Clinical Trials Llc
Boston 4930956, Massachusetts 6254926 02131

ELIXIA
Springfield 4951788, Massachusetts 6254926 01103

IMA Clinical Research Las Vegas
Las Vegas 5506956, Nevada 5509151 89102

Redbird Research
Las Vegas 5506956, Nevada 5509151 89119

IMA Clinical Research
Albuquerque 5454711, New Mexico 5481136 87109

Integrative Clinical Trials
Brooklyn 5110302, New York 5128638 11229

Richmond Behavioral Associates
Staten Island 5139568, New York 5128638 10314

New Hope Clinical Research
Charlotte 4460243, North Carolina 4482348 28211

Pahl Pharmaceutical Professionals Llc
Oklahoma City 4544349, Oklahoma 4544379 73112

Lehigh Center For Clinical Research
Allentown 5178127, Pennsylvania 6254927 18103

Clinical Neuroscience Solutions, Inc.
Memphis 4641239, Tennessee 4662168 38119

Delricht Research - Plano
Plano 4719457, Texas 4736286 75024

Aim Trials, Llc
Plano 4719457, Texas 4736286 75093

Grayline Research Center
Wichita Falls 4741752, Texas 4736286 76309

Core Clinical Research
Everett 5793933, Washington 5815135 98201

More Details

NCT ID
NCT06775379
Status
Recruiting
Sponsor
Xenon Pharmaceuticals Inc.

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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