NCT07221877PHASE4Recruiting
A Study to Evaluate the Effect of KarXT on Urological Safety
Bristol-Myers Squibb
Start Date
1/20/2026
Completion Date
12/30/2027
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.
Eligibility Criteria
Age Range: 18 years to 65 years
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
Interventions
DRUG
Xanomeline/trospium chloride
Conditions
Schizophrenia
Locations
Pillar Clinical Research- Little Rock
Little Rock, Arkansas 72204
United States
Clinical Innovations, Inc. dba CITrials
Bellflower, California 90706
United States
CenExel CNS - Garden Grove
Garden Grove, California 92845
United States
ATP Clinical Research
Orange, California 92866
United States
Innovative Clinical Research
Lauderhill, Florida 33319
United States
Health Synergy Clinical Research
West Palm Beach, Florida 33407
United States
Uptown Research Institute
Chicago, Illinois 60640
United States
Pillar Clinical Research -Chicago
Chicago, Illinois 60641
United States
IMA Clinical Research Las Vegas
Las Vegas, Nevada 89102
United States
Hassman Research Institute Marlton Site
Marlton, New Jersey 08053
United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania 19104
United States
Local Institution - 0001
Austin, Texas 78754
United States
InSite Clinical Research
DeSoto, Texas 75115
United States