Ireland
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Recruiting Phase 4

A Study to Evaluate the Effect of KarXT on Urological Safety

NCT07221877 · tracked via the Priya Life Science USA tracker
Phase
Phase 4
Started
2026-01-20
Last updated
2026-10-19

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

Xanomeline/trospium chloride →

Xanomeline/trospium chloride: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change from baseline in voiding dynamics (Qmax) over time — Up to 12 months
  • Change from baseline in post-void residual volume (PVR) over time — Up to 12 months

Trial sites (16)

FacilityCityRegionStatus
Pillar Clinical Research- Little Rock Little Rock Arkansas Recruiting
Clinical Innovations, Inc. dba CITrials Bellflower California Recruiting
CenExel CNS - Garden Grove Garden Grove California Recruiting
ATP Clinical Research Orange California Recruiting
Local Institution - 0018 Redlands California Not Yet Recruiting
Collaborative Neuroscience Research, LLC Torrance California Recruiting
Local Institution - 0020 West Covina California Not Yet Recruiting
Health Synergy Clinical Research Boynton Beach Florida Recruiting
Innovative Clinical Research Lauderhill Florida Recruiting
Uptown Research Institute Chicago Illinois Recruiting
Pillar Clinical Research -Chicago Chicago Illinois Recruiting
IMA Clinical Research Las Vegas Las Vegas Nevada Recruiting
Hassman Research Institute Marlton Site Marlton New Jersey Recruiting
Adams Clinical Philadelphia Philadelphia Pennsylvania Recruiting
Local Institution - 0001 Austin Texas Not Yet Recruiting
Adams Clinical Dallas DeSoto Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07221877 on ClinicalTrials.gov ↗ ← All trials in the USA