Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Xanomeline/trospium chloride for Schizophrenia

This study wants to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Official registry: https://clinicaltrials.gov/study/NCT07221877 · Bristol-Myers Squibb · enrollment listed as 60

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Xanomeline/trospium chloride. The registry lists allocation as na. This study wants to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

They plan to enroll about 60 people at 16 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Xanomeline/trospium chloride

Primary outcome (registry wording): Change from baseline in voiding dynamics (Qmax) over time

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • 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 body-mass index (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

Public study contact (from the registry)

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

16 listed

Related recruiting trials in this snapshot

RecruitingPhase 1 / Phase 2Houston, Texas
Phase 1 / Phase 2: testing Ocrelizumab infusion for Schizo-Affective Type of Psychosis

Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them.

NCT03971487 · Official ClinicalTrials.gov record · The Methodist Hospital Research Institute

FAQ about this NCT record

Is NCT07221877 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07221877?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07221877?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary