A Randomized Study of Azetukalner Versus Placebo in Major Depressive Disorder

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT06775379
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-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)

Key Dates

Start date
Dec 20, 2024
Status verified
Jan 2025
Primary completion
Aug 31, 2026
Completion
Oct 31, 2026

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 (46)

FacilityCityStateZIPSite coordinators
IMA Clinical Research PhoenixPhoenixArizona85012-
Woodland International Research GroupLittle RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758-
Behavioral Research Specialists, LlcGlendaleCalifornia91206-
Marvel Clinical ResearchHuntington BeachCalifornia92647-
Irvine Clinical ResearchIrvineCalifornia92614-
CalNeuro Research Group, Inc.Los AngelesCalifornia90025-
Excell Research Inc.OceansideCalifornia92056-
Atp Clinical ResearchOrangeCalifornia92866-
Nrc Research InstituteOrangeCalifornia92868-
CenExel CNS-TO (Collaborative Neuroscience Research)TorranceCalifornia90504-
Sunwise Clinical ResearchWalnut CreekCalifornia94596-
Ct Clinical Research AssociatesCromwellConnecticut06416-
CNS Clinical Research GroupCoral SpringsFlorida33067-
NeoClinical ResearchHialeahFlorida33016-
Clinical Neuroscience Solutions, Inc.JacksonvilleFlorida32256-
Accel Research Sites LakelandLakelandFlorida33803-
Accel Research Sites - St. Petersburg-LargoLargoFlorida33777-
PharmaSouth ResearchMiamiFlorida33165-
Quantum Clinical TrialsMiami BeachFlorida33140-
Harmony Clinical Research IncNorth Miami BeachFlorida33162-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32801-
Combined Research Orlando Phase I-IvOrlandoFlorida32807-
Panhandle Research and Medical ClinicPensacolaFlorida32503-
Advanced Discovery ResearchAtlantaGeorgia30318-
Synexus - AtlantaAtlantaGeorgia30328-
CenExel iResearchDecaturGeorgia30030-
Psych Atlanta, PcMariettaGeorgia30060-
Cenexel Iresearch - SavannahSavannahGeorgia31405-
Northwest Clinical Trials IncBoiseIdaho83704-
Chicago Research Center Inc.ChicagoIllinois60634-
Boston Clinical Trials LlcBostonMassachusetts02131-
ELIXIASpringfieldMassachusetts01103-
IMA Clinical Research Las VegasLas VegasNevada89102-
Redbird ResearchLas VegasNevada89119-
IMA Clinical ResearchAlbuquerqueNew Mexico87109-
Integrative Clinical TrialsBrooklynNew York11229-
Richmond Behavioral AssociatesStaten IslandNew York10314-
New Hope Clinical ResearchCharlotteNorth Carolina28211-
Pahl Pharmaceutical Professionals LlcOklahoma CityOklahoma73112-
Lehigh Center For Clinical ResearchAllentownPennsylvania18103-
Clinical Neuroscience Solutions, Inc.MemphisTennessee38119-
Aim Trials, LlcPlanoTexas75093-
Delricht Research - PlanoPlanoTexas75024-
Grayline Research CenterWichita FallsTexas76309-
Core Clinical ResearchEverettWashington98201-

Find similar trials in Phoenix, AZ

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
IMA Clinical Research Phoenix· Phoenix, AZWoodland International Research Group· Little Rock, ARWoodland Research Northwest· Rogers, ARBehavioral Research Specialists, Llc· Glendale, CAMarvel Clinical Research· Huntington Beach, CAIrvine Clinical Research· Irvine, CA

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