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-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)

Eligibility

Age range: 18–74 years
Sex: All
Healthy volunteers: No

Detailed criteria

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

Drug
Azetukalner
Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks
Drug
Placebo
Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Locations (51)

IMA Clinical Research Phoenix
Phoenix, Arizona
Woodland International Research Group
Little Rock, Arkansas
Woodland Research Northwest
Rogers, Arkansas
Behavioral Research Specialists, Llc
Glendale, California
Marvel Clinical Research
Huntington Beach, California
Irvine Clinical Research
Irvine, California