Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

NCT07101094 | Recruiting FDA Drug

• 1 other identifier: CN012-0066
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 18

Brief Summary

The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Participant medication preference as assessed by the Preference of Medication (POM) questionnaire

  Month 1, Month 3, Month 6

• Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)

  Baseline, Month 1, Month 3, Month 6

Secondary Outcomes (8)

• Treatment titration plan as described by the treating clinician

  Baseline, Month 1, Month 3, Month 6

• Treatment switch plan as described by the treating physician

  Baseline, Month 1, Month 3, Month 6

• Treatment dose prescribed

  Baseline, Month 1, Month 3, Month 6

• Concomitant medication prescribed

  Baseline, Month 1, Month 3, Month 6

• Number of participants who are prescribed a treatment dose change

  Month 1, Month 3, Month 6

Study Arms (1)

Participants receiving xanomeline and trospium chloride (X/T) therapy

Drug: xanomeline and trospium chloride (X/T) therapy

Interventions

xanomeline and trospium chloride (X/T) therapy DRUG

According to the product label

Participants receiving xanomeline and trospium chloride (X/T) therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (18)

Local Institution - 0009

Orange, California, 92868, United States

NOT YET RECRUITING

Lumos Clinical Research Center

San Jose, California, 95124, United States

RECRUITING

Local Institution - 0003

Evanston, Illinois, 60201, United States

NOT YET RECRUITING

Local Institution - 0007

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Local Institution - 0017

Bel Air, Maryland, 21015, United States

NOT YET RECRUITING

Local Institution - 0004

Catonsville, Maryland, 21228, United States

WITHDRAWN

Local Institution - 0008

Belmont, Massachusetts, 02478-1064, United States

NOT YET RECRUITING

Local Institution - 0002

Boston, Massachusetts, 02118, United States

NOT YET RECRUITING

Mayflower Clinical

South Dartmouth, Massachusetts, 02747, United States

RECRUITING

Omaha Insomnia and Psychiatric Services

Omaha, Nebraska, 68144, United States

RECRUITING

Hackensack Meridian Health - Carrier Clinic

Belle Mead, New Jersey, 08502, United States

RECRUITING

Radial - Manhattan

New York, New York, 10018, United States

RECRUITING

New Dawn Psychiatric Services, PLLC

Kinston, North Carolina, 28501, United States

RECRUITING

Local Institution - 0018

Rose Hill, North Carolina, 28458, United States

NOT YET RECRUITING

Westlake Brain Health

Westlake, Ohio, 44145, United States

RECRUITING

Continuum Health Providers

Fort Mill, South Carolina, 29708, United States

RECRUITING

Haracec Clinical Research

El Paso, Texas, 79902, United States

RECRUITING

Local Institution - 0013

Longview, Texas, 75601, United States

NOT YET RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: August 3, 2025
• Study Start: September 22, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): May 14, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)