Clinical Trials in the USA / NCT07221877
Recruiting
Phase 4
A Study to Evaluate the Effect of KarXT on Urological Safety
NCT07221877 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Schizophrenia
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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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