KarXT's effects on bladder and urinary function

A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety

This trial will test whether KarXT affects bladder emptying and other urinary safety measures in adults with schizophrenia who can stop other antipsychotics.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Bristol-Myers Squibb (Industry-sponsored)
• Locations: 14 sites (Little Rock, Arkansas and 13 other locations)
• Trial ID: NCT07221877 on ClinicalTrials.gov

What this trial studies

This Phase 4 interventional study gives xanomeline/trospium to adults with DSM-5 schizophrenia who discontinue other antipsychotics to characterize voiding dynamics and urological safety. Participants must meet stability criteria (PANSS ≤ 80, CGI-S ≤ 4, BMI 18–40) and will undergo baseline and on-treatment urological assessments such as urinary flow/retention measures and adverse event monitoring. The trial is conducted at multiple US clinical sites with scheduled clinic visits for testing and safety surveillance. Data will be used to determine whether KarXT causes clinically significant urinary side effects in this population.

Who should consider this trial

Good fit: Adults 18–65 with DSM-5 schizophrenia who are clinically stable (PANSS ≤ 80, CGI-S ≤ 4), have BMI 18–40, and are willing and able to stop other antipsychotic medications are the intended participants.

Not a fit: People with newly diagnosed schizophrenia, recent other psychiatric diagnoses or substance use disorder, significant medical conditions, pregnancy or breastfeeding, suicidal risk, or who are unwilling to discontinue antipsychotics are unlikely to qualify or benefit from participation.

Why it matters

Potential benefit: If KarXT shows acceptable urological safety, it could provide an additional antipsychotic option with manageable bladder-related side effects for people with schizophrenia.

How similar studies have performed: Prior KarXT trials have shown antipsychotic efficacy and generally acceptable tolerability, but focused urological safety testing like this Phase 4 study is relatively new.

Eligibility criteria

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

Where this trial is running

Little Rock, Arkansas and 13 other locations

• Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (Recruiting)
• Clinical Innovations, Inc. dba CITrials — Bellflower, California, United States (Recruiting)
• Local Institution - 0009 — Culver City, California, United States (Not_yet_recruiting)
• CenExel CNS - Garden Grove — Garden Grove, California, United States (Recruiting)
• ATP Clinical Research — Orange, California, United States (Recruiting)
• Local Institution - 0003 — Miami, Florida, United States (Not_yet_recruiting)
• Local Institution - 0004 — West Palm Beach, Florida, United States (Not_yet_recruiting)
• Uptown Research Institute — Chicago, Illinois, United States (Recruiting)
• Local Institution - 0010 — Chicago, Illinois, United States (Not_yet_recruiting)
• IMA Clinical Research Las Vegas — Las Vegas, Nevada, United States (Recruiting)
• Hassman Research Institute Marlton Site — Marlton, New Jersey, United States (Recruiting)
• Adams Clinical Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
• Local Institution - 0001 — Austin, Texas, United States (Not_yet_recruiting)
• InSite Clinical Research — DeSoto, Texas, United States (Recruiting)

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Conditions Schizophrenia