An Open-label Study of Azetukalner in Bipolar I or II Depression (X-CEED-OLE)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Xenon Pharmaceuticals Inc.
Study ID
NCT07217860
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 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 52 weeks.

Study Details

X-CEED-OLE is a Phase 3, multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner in adult participants who successfully completed an antecendent Phase 3 azetukalner bipolar depression study.

Key Dates

Start date
Oct 30, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
400 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azetukalner 20 mg

Primary Outcome Measure

Severity and frequency of treatment-emergent adverse events, serious adverse events, adverse events of special interest, and events of clinical interest [ Time Frame: From the start of treatment in the open-label extension study through 8 weeks after the last dose ]

Locations (15)

FacilityCityStateZIPSite coordinators
Woodland International Research GroupLittle RockArkansas72211-
Woodland Research NorthwestRogersArkansas72758-
ProScience Research GroupCulver CityCalifornia90230-
PharmaSouth Research, LLCCoral GablesFlorida33146-
Clinical Neuroscience Solutions, Inc.JacksonvilleFlorida32256-
Clinical Neuroscience SolutionsOrlandoFlorida32801-
Synexus Clinical Research, Inc.AtlantaGeorgia30328-
CenExel iResearchDecaturGeorgia30030-
Denali Health Atlanta, LLCStone MountainGeorgia30083-
Lumina Clinical Research CenterCherry HillNew Jersey92866-
Neurobehavioral Research IncCedarhurstNew York11516-
Lehigh Center for Clinical ResearchAllentownPennsylvania18103-
Clinical Neuroscience Solutions MemphisMemphisTennessee38119-
Grayline Research CenterWichita FallsTexas76309-
Core Clinical ResearchEverettWashington98201-

Find similar trials in Little Rock, AR

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Woodland International Research Group· Little Rock, ARWoodland Research Northwest· Rogers, ARProScience Research Group· Culver City, CAPharmaSouth Research, LLC· Coral Gables, FLClinical Neuroscience Solutions, Inc.· Jacksonville, FLClinical Neuroscience Solutions· Orlando, FL

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