A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT07172516
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-CEED is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of azetukalner in adult participants diagnosed with bipolar I or II disorder who are currently in a depressive episode (bipolar depression).

Key Dates

Start date
Aug 8, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
400 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 Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Week 6. [ Time Frame: Baseline to Week 6 ]

Central Contacts

Locations (28)

FacilityCityStateZIPSite coordinators
Noble Clinical ResearchTucsonArizona85704-
Woodland International Research GroupLittle RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758-
Clinical Innovations IncBellflowerCalifornia90706-
ProScience Research GroupCulver CityCalifornia90230-
ATP Clinical ResearchOrangeCalifornia92866-
NRC Research InstituteOrangeCalifornia92868-
Clinical Innovations IncRiversideCalifornia92506-
PharmaSouth Research, LLCCoral GablesFlorida33146-
Clinical Neuroscience Solutions, Inc.JacksonvilleFlorida32256-
Central Miami Medical InstituteMiamiFlorida33125-
Clinical Neuroscience Solutions, IncOrlandoFlorida32801-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Synexus Clinical Research, Inc.AtlantaGeorgia30328-
CenExel iResearchDecaturGeorgia30030-
Denali Health Atlanta, LLCStone MountainGeorgia30083-
Advanced Quality Medical ResearchOrland ParkIllinois60462-
Psychiatric Care and Research CenterO'FallonMissouri63368-
Redbird Clinical Research, LLCLas VegasNevada89119-
Lumina Clinical Research CenterCherry HillNew Jersey08002-
Integrative Clinical Trials LLCBrooklynNew York11229-
Neurobehavioral Research IncCedarhurstNew York11516-
DelRicht ResearchCharlotteNorth Carolina28210-
Lehigh Center for Clinical ResearchAllentownPennsylvania18103-
Clinical Neuroscience Solutions, IncMemphisTennessee38119-
Elevate Synapsis, LLCAtascocitaTexas77346-
Grayline Research CenterWichita FallsTexas76309-
Core Clinical ResearchEverettWashington98201-

Find similar trials in Tucson, AZ

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Noble Clinical Research· Tucson, AZWoodland International Research Group· Little Rock, ARWoodland Research Northwest· Rogers, ARClinical Innovations Inc· Bellflower, CAProScience Research Group· Culver City, CAATP Clinical Research· Orange, CA

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