A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Part of paid clinical trials in Bentonville, Arkansas.

Sponsor
Bristol-Myers Squibb
Study ID
NCT06951698
Phase
PHASE3
Status
Recruiting
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Conditions

  • Bipolar-I Disorder With Mania or Mania With Mixed Features

Eligibility Criteria

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

Interventions

  • KarXT — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Key Dates

Start date
Jun 11, 2025
Status verified
Apr 2026
Primary completion
Nov 1, 2026
Completion
Nov 1, 2026

Study Design

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

Arms

  • Experimental: KarXT
    Flexible dosing
  • Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in Young Mania Rating Scale (YMRS) score [ Time Frame: At week 3 ]

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 (22)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research - BentonvilleBentonvilleArkansas72712
Fayz Hudefi, Site 0058
479-367-2688
Woodland International Research GroupLittle RockArkansas72211
George Konis, Site 0011
501-221-8681
Advanced Research Center Inc.AnaheimCalifornia92805
Steven Macina, Site 0005
714-999-6688
CITrialsBellflowerCalifornia90706
Robert Bota, Site 0008
562-748-4999
Local Institution - 0014CerritosCalifornia90703
Site 0014
Collaborative Neuroscience Research, LLCLong BeachCalifornia90806
David Walling, Site 0059
714-799-7799
Catalina Research Institute, LLCMontclairCalifornia91763
Stephen Volk, Site 0072
909-590-8409
NRC Research InstituteOrangeCalifornia92868
Tony Ortiz, Site 0053
714-289-1100
Connecticut Mental Health CenterNew HavenConnecticut06519
Deepak D'Souza, Site 0124
20393257112594
Research Centers of America ( Hollywood )HollywoodFlorida33024
Edwin Gomez, Site 0043
954-604-3900
Advanced Research Institute of MiamiHomesteadFlorida33033
Moraima Trujillo, Site 0020
305-246-0001
South Florida Research Phase I-IVMiamiFlorida33166
Silvia Silva Duluc, Site 0069
305-669-6166
Innovative Clinical Research, Inc.Miami LakesFlorida33016
Rishi Kakar, Site 0054
786-512-4106
Local Institution - 0015Miami LakesFlorida33016
Site 0015
Health Synergy Clinical ResearchWest Palm BeachFlorida33407
Mohammad Nisar, Site 0023
786-831-7303
Synexus Clinical Research US, Inc.AtlantaGeorgia30328
Bethany Davis, Site 0009
404-255-6005
CenExel iResearch, LLCSavannahGeorgia31405
Michael Mobley, Site 0057
912-744-0800
Pillar Clinical Research -ChicagoChicagoIllinois60641
Roueen Rafeyan, Site 0047
312-865-6336
Richmond Behavioral AssociatesStaten IslandNew York10314
Peter Weiden, Site 0030
917-701-7484
Neuro-Behavioral Clinical ResearchNorth CantonOhio44720
Shishuka Malhotra, Site 0013
330-493-1118
Local Institution - 0029IrvingTexas75062-
Pillar Clinical Research - RichardsonRichardsonTexas75080
Scott Bartley, Site 0044
214-396-4844

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Pillar Clinical Research - Bentonville· Bentonville, ARWoodland International Research Group· Little Rock, ARAdvanced Research Center Inc.· Anaheim, CACITrials· Bellflower, CALocal Institution - 0014· Cerritos, CACollaborative Neuroscience Research, LLC· Long Beach, CA