A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07140913
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Xanomeline/Trospium Chloride — DRUG
    Specified dose on specified days
  • Placebo — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Key Dates

Start date
Oct 8, 2025
Status verified
Jun 2026
Primary completion
Jun 28, 2027
Completion
Jun 28, 2027

Study Design

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

Arms

  • Experimental: KarXT + Lithium, Valproate, or Lamotrigine
  • Placebo Comparator: Placebo + Lithium, Valproate, or Lamotrigine

Primary Outcome Measure

Change from baseline in Young Mania Rating Scale (YMRS) at Week 5 [ Time Frame: At Week 5 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (20)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research - BentonvilleBentonvilleArkansas72712
Fayz Hudefi, Site 0029
479-367-2688
Pillar Clinical Research- Little RockLittle RockArkansas72204
Leslie Smith, Site 0018
501-350-3285
Clinical Innovations, Inc. dba CITrialsBellflowerCalifornia90706
Gerald Maguire, Site 0110
562-249-6956
Inland Psychiatric Medical Group.ChinoCalifornia91710
Nandita Puchakayala, Site 0049
909-488-9116
Proscience Research GroupCulver CityCalifornia90230
Marina Bussel, Site 0014
424-227-8127
Omega Clinical Trials - La HabraLa HabraCalifornia90631
Wakelin McNeel, Site 0151
562-690-2200
Catalina Research Institute, LLCMontclairCalifornia91763
Stephen Volk, Site 0037
909-590-8409
NRC Research InstituteOrangeCalifornia92868
Tony Ortiz, Site 0148
714-289-1100
Clinical Innovations, Inc. dba CITrialsRiversideCalifornia92506
Evagelos Coskinas, Site 0106
951-300-4924
Velocity Clinical Research, Hallandale BeachHallandaleFlorida33009
Beth Safirstein, Site 0015
South Florida Research Phase I-IVMiamiFlorida33166
Silvia Silva Duluc, Site 0021
305-669-6166
Health Synergy Clinical ResearchWest Palm BeachFlorida33407
Mohammad Nisar, Site 0016
786-831-7303
CenExel iResearch, LLCSavannahGeorgia31405
Yael Elfassy, Site 0136
912-744-0800
Pillar Clinical Research -ChicagoChicagoIllinois60641
Roueen Rafeyan, Site 0017
312-865-6336
Arch Clinical TrialsSt LouisMissouri63141
Junaid Syed, Site 0023
314-771-6387
Richmond Behavioral AssociatesStaten IslandNew York10314
Peter Weiden, Site 0032
917-701-7484
Community Clinical ResearchAustinTexas78754
David Brown, Site 0026
512-323-2622
Elevate Clinical Research-HoustonHoustonTexas77058
Matthew Brams, Site 0160
Prime Clinical Research - MansfieldMansfieldTexas76063
Jamie Alexander, Site 0156
817-907-7330
Pillar Clinical Research - RichardsonRichardsonTexas75080
Scott Bartley, Site 0033
214-396-4844

Find similar trials in Bentonville, AR

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Pillar Clinical Research - Bentonville· Bentonville, ARPillar Clinical Research- Little Rock· Little Rock, ARClinical Innovations, Inc. dba CITrials· Bellflower, CAInland Psychiatric Medical Group.· Chino, CAProscience Research Group· Culver City, CAOmega Clinical Trials - La Habra· La Habra, CA

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