Recruiting

KarXT

Sponsor:

Bristol-Myers Squibb

Code:

NCT07221877

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Xanomeline/trospium chloride

Study Details

Brief summary:

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Conditions

Schizophrenia

Study ID

NCT07221877

Start date

Jan 20, 2026

Status verified date

Jun, 2026

Completion date

Dec 30, 2027

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria

  • Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).
  • Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2.
  • Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.

Exclusion Criteria

  • Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
  • Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.
  • Other protocol-defined Inclusion/Exclusion criteria apply

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

Interventions

Xanomeline/trospium chloride

Specified dose on specified days

Primary outcome measure

  • Change from baseline in voiding dynamics (Qmax) over time [ Time Frame: Up to 12 months ]
  • Change from baseline in post-void residual volume (PVR) over time [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Pillar Clinical Research- Little Rock

Recruiting

Little Rock, Arkansas, United States, 72204

Contacts

Leslie Smith, Site 0017

501-350-3285

Clinical Innovations, Inc. dba CITrials

Recruiting

Bellflower, California, United States, 90706

Contacts

Robert Bota, Site 0007

562-748-4999

CenExel CNS - Garden Grove

Recruiting

Garden Grove, California, United States, 92845

Contacts

David Walling, Site 0006

714-799-7799

ATP Clinical Research

Recruiting

Orange, California, United States, 92866

Contacts

Gustavo Alva, Site 0016

949-354-5353

Innovative Clinical Research

Recruiting

Lauderhill, Florida, United States, 33319

Contacts

Rishi Kakar, Site 0003

786-512-4106

Health Synergy Clinical Research

Recruiting

West Palm Beach, Florida, United States, 33407

Contacts

Mohammad Nisar, Site 0004

786-831-7303

Uptown Research Institute

Recruiting

Chicago, Illinois, United States, 60640

Contacts

John Sonnenberg, Site 0005

773-968-9868

Pillar Clinical Research -Chicago

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Roueen Rafeyan, Site 0010

312-865-6336

IMA Clinical Research Las Vegas

Recruiting

Las Vegas, Nevada, United States, 89102

Contacts

Mustafa Rawaf, Site 0013

702-527-7401

Hassman Research Institute Marlton Site

Recruiting

Marlton, New Jersey, United States, 08053

Contacts

Elan Cohen, Site 0002

267-981-8911

Adams Clinical Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Cassie Blanchard, Site 0014

631-252-0769

InSite Clinical Research

Recruiting

DeSoto, Texas, United States, 75115

Contacts

Benji Kurian, Site 0015

214-497-3151

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-06-03.