Treatment satisfaction and use of KarXT (xanomeline + trospium) for adults with schizophrenia
Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
Bristol-Myers Squibb · NCT07101094
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb (industry) |
| Locations | 18 sites (Orange, California and 17 other locations) |
| Trial ID | NCT07101094 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Orange, California and 17 other locations
- Local Institution - 0009 — Orange, California, United States (NOT_YET_RECRUITING)
- Lumos Clinical Research Center — San Jose, California, United States (RECRUITING)
- Local Institution - 0003 — Evanston, Illinois, United States (NOT_YET_RECRUITING)
- Local Institution - 0007 — Baltimore, Maryland, United States (NOT_YET_RECRUITING)
- Local Institution - 0017 — Bel Air, Maryland, United States (NOT_YET_RECRUITING)
- Local Institution - 0004 — Catonsville, Maryland, United States (WITHDRAWN)
- Local Institution - 0008 — Belmont, Massachusetts, United States (NOT_YET_RECRUITING)
- Local Institution - 0002 — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Mayflower Clinical — South Dartmouth, Massachusetts, United States (RECRUITING)
- Omaha Insomnia and Psychiatric Services — Omaha, Nebraska, United States (RECRUITING)
- Hackensack Meridian Health - Carrier Clinic — Belle Mead, New Jersey, United States (RECRUITING)
- Local Institution - 0015 — New York, New York, United States (NOT_YET_RECRUITING)
- New Dawn Psychiatric Services, PLLC — Kinston, North Carolina, United States (RECRUITING)
- Local Institution - 0018 — Rose Hill, North Carolina, United States (NOT_YET_RECRUITING)
- Westlake Brain Health — Westlake, Ohio, United States (RECRUITING)
- Continuum Health Providers — Fort Mill, South Carolina, United States (RECRUITING)
- Local Institution - 0012 — El Paso, Texas, United States (NOT_YET_RECRUITING)
- Local Institution - 0013 — Longview, Texas, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia