A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder (X-NOVA3)

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT07076407
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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)

Key Dates

Start date
Jul 8, 2025
Status verified
Jul 2025
Primary completion
May 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Azetukalner
    Azetukalner 20 mg
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

Change from baseline in the Hamilton Depression Rating Scale, 17-item (HAMD-17) score at Week 6 [ Time Frame: Baseline to Week 6 ]

Central Contacts

Locations (35)

FacilityCityStateZIPSite coordinators
Harmonex Neuroscience ResearchDothanAlabama36303-
University of Alabama at Birmingham, Huntsville Regional Medical CampusHuntsvilleAlabama35801-
Pillar Clinical ResearchBentonvilleArkansas72712-
SanRo Clinical Research GroupBryantArkansas72022-
Clinical Innovations IncBellflowerCalifornia90706-
Center for NeurohealthLa JollaCalifornia93037-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103-
California Neuroscience ResearchSherman OaksCalifornia91403-
Pacific Clinical Research Management GroupUplandCalifornia91786-
Institute of LivingHartfordConnecticut06106-
Gulfcoast Clinical Research CenterFort MyersFlorida33912-
Sarkis Clinical TrialsGainesvilleFlorida32607-
Equipath Health and Research Tampa Bay, LlcRiverviewFlorida33578-
Delricht ResearchAtlantaGeorgia30329-
Emory University Brain Health CenterAtlantaGeorgia30329-
Advanced Quality Medical ResearchOrland ParkIllinois60462-
Smart Trials, LLCJeffersonLouisiana70121-
Pharmasite Research Inc.BaltimoreMaryland21208-6605-
Adams Clinical BostonBostonMassachusetts02116-
Activmed Practices & Research, Llc - MethuenMethuenMassachusetts01844-
Adams Clinical WatertownWatertownMassachusetts02472-
Vitalix Clinical, IncWorcesterMassachusetts01608-
Psychiatric Care and Research CenterO'FallonMissouri63368-
St. Charles Psychiatric Associates - Midwest Research GroupSaint CharlesMissouri63304-
Lumina Clinical Research CenterCherry HillNew Jersey08002-
Princeton Medical InstitutePrincetonNew Jersey08540-
Bio Behavioral HealthToms RiverNew Jersey08755-
Bioscience Research, LLCMount KiscoNew York10549-
Fieve Clinical Research, Inc.New YorkNew York10017-
IMA Clinical ResearchNew YorkNew York10128-
Magnolia Clinical Research, LlcCaryNorth Carolina27511-
Insight Clinical TrialsIndependenceOhio44195-
Sooner Clinical ResearchOklahoma CityOklahoma73116-
Austin Clinical Trial PartnersAustinTexas78737-
Boeson ResearchProvoUtah84604-

Find similar trials in Dothan, AL

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Harmonex Neuroscience Research· Dothan, ALUniversity of Alabama at Birmingham, Huntsville Regional Medical Campus· Huntsville, ALPillar Clinical Research· Bentonville, ARSanRo Clinical Research Group· Bryant, ARClinical Innovations Inc· Bellflower, CACenter for Neurohealth· La Jolla, CA

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