Treatment satisfaction and use of KarXT (xanomeline + trospium) for adults with schizophrenia
Official title: Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
Run by Bristol-Myers Squibb · NCT07101094 · Data updated 2026-11-12
This registry will collect information from adults with schizophrenia in the U.S. who start KarXT (xanomeline plus trospium) to see how satisfied they are with the treatment and how it's used.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 20 sites (Orange, California and 19 other locations) |
| Status | Recruiting |
| Started | September 22, 2025 |
| Main results expected | January 31, 2029 |
| Study ends | May 14, 2029 |
| Registry record updated | September 30, 2026 |
| Trial ID | NCT07101094 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a confirmed diagnosis of schizophrenia in the U.S. who have an initial prescription for xanomeline plus trospium and can complete patient-reported outcomes in English or Spanish.
✕Probably not a fit
People who have previously used KarXT, are enrolled in an interventional clinical trial, or cannot complete electronic/paper outcome reports are unlikely to be eligible or to benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry will follow adults with schizophrenia in the United States who start treatment with KarXT (xanomeline plus trospium chloride) to document treatment satisfaction, preferences, and real-world utilization. Participants provide informed consent and report outcomes in English or Spanish via an electronic device or on paper, and must be initiating XT for the first time. The registry excludes people currently in interventional trials or with prior XT use and collects patient-reported measures alongside basic treatment and demographic information. Sites listed include locations in California and Illinois, and data will describe how KarXT is used and experienced outside controlled clinical trials.
Why it matters
Potential benefit: If successful, this registry could help prescribers and patients understand how KarXT is used and how satisfied patients are, informing better treatment decisions.
How similar studies have gone: Randomized clinical trials have shown KarXT can reduce schizophrenia symptoms, but real-world registries focused on treatment satisfaction and utilization are limited, so this approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged ≥18 years at index date. * Have a confirmed diagnosis of schizophrenia before index date. * Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy. * Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines. * Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish). * English or Spanish speaking. Exclusion Criteria: * Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening. * Evidence of use of XT prior to time of eligibility screening.
Where it's running
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ATP Clinical Research - Costa Mesa
Orange, California, United States Recruiting -
Lumos Clinical Research Center
San Jose, California, United States Recruiting -
Evanston Hospital
Evanston, Illinois, United States Recruiting -
The Johns Hopkins Hospital
Baltimore, Maryland, United States Recruiting -
Boston Medical Center
Boston, Massachusetts, United States Recruiting -
Omaha Insomnia and Psychiatric Services
Omaha, Nebraska, United States Recruiting
Show 14 more locations
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Hackensack Meridian Health - Carrier Clinic
Belle Mead, New Jersey, United States Recruiting -
Radial - Manhattan
New York, New York, United States Recruiting -
New Dawn Psychiatric Services, PLLC
Kinston, North Carolina, United States Recruiting -
New Dimension Group
Rose Hill, North Carolina, United States Recruiting -
Westlake Brain Health
Westlake, Ohio, United States Recruiting -
Continuum Health Providers
Fort Mill, South Carolina, United States Recruiting -
Haracec Clinical Research
El Paso, Texas, United States Recruiting -
C-Trilogy Outreach
Longview, Texas, United States Recruiting -
Local Institution - 0019
Miami, Florida, United States Not yet recruiting -
Local Institution - 0017
Bel Air, Maryland, United States Withdrawn -
Local Institution - 0004
Catonsville, Maryland, United States Withdrawn -
Local Institution - 0008
Belmont, Massachusetts, United States Completed -
Local Institution - 0011
South Dartmouth, Massachusetts, United States Completed -
Local Institution - 0020
Grand Island, Nebraska, United States Not yet recruiting
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.