A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
Xenon Pharmaceuticals Inc.
Summary
X-NOVA3 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)
Eligibility
- Age range
- 18–74 years
- Sex
- All
- Healthy volunteers
- No
Key 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. Key Exclusion Criteria: * Participant has a primary diagnosis of a mood disorder other than MDD. *…
Interventions
- DrugAzetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
- DrugPlacebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks
Locations (42)
- Harmonex Neuroscience ResearchDothan, Alabama
- University of Alabama at Birmingham, Huntsville Regional Medical CampusHuntsville, Alabama
- Pillar Clinical ResearchBentonville, Arkansas
- SanRo Clinical Research GroupBryant, Arkansas
- Clinical Innovations IncBellflower, California
- Center for NeurohealthLa Jolla, California