NCT07221877RecruitingPhase 4
A Study to Evaluate the Effect of KarXT on Urological Safety
A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
Source: ClinicalTrials.gov · Last updated 19 Oct 2026
Brief summary (registry, in English)
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Oct 2025
- Start date
- 20 Jan 2026
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Schizophrenia
- NCT number
- NCT07221877
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 20 Jan 2026 to the primary completion date, 30 Dec 2027
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Austin | United States | Not yet recruiting |
| Clinical Innovations, Inc. dba CITrials Coordinator of this site? Confirm its status | Bellflower | United States | Recruiting |
| Health Synergy Clinical Research Coordinator of this site? Confirm its status | Boynton Beach | United States | Recruiting |
| Uptown Research Institute Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Pillar Clinical Research -Chicago Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| Adams Clinical Dallas Coordinator of this site? Confirm its status | DeSoto | United States | Recruiting |
| CenExel CNS - Garden Grove Coordinator of this site? Confirm its status | Garden Grove | United States | Recruiting |
| IMA Clinical Research - Las Vegas Coordinator of this site? Confirm its status | Las Vegas | United States | Recruiting |
| Innovative Clinical Research Coordinator of this site? Confirm its status | Lauderhill | United States | Recruiting |
| Pillar Clinical Research - Little Rock Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Hassman Research Institute Marlton Site Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| ATP Clinical Research Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Adams Clinical Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Redlands | United States | Not yet recruiting |
| Collaborative Neuroscience Research LLC Coordinator of this site? Confirm its status | Torrance | United States | Recruiting |
| - Coordinator of this site? Confirm its status | West Covina | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.