Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: xanomeline and trospium chloride (XT) therapy

• Registration Number: NCT07101094
• Lead Sponsor: Bristol-Myers Squibb

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 (XT) therapy

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-23
• Study First Submitted QC: 2025-08-01
• Last Update Submitted: 2025-08-01
• Study First Posted: 2025-08-03
• Last Update Posted: 2025-08-03
• Study Start: 2025-09-30
• Primary Completion: 2029-03-30
• Study Completion: 2029-03-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants receiving xanomeline and trospium chloride (XT) therapy	xanomeline and trospium chloride (XT) therapy	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Reasons for treatment discontinuation	Month 1, Month 3, Month 6
Treatment switch plan as described by the treating physician	Baseline, Month 1, Month 3, Month 6
Number of participants who are prescribed a treatment dose change	Month 1, Month 3, Month 6
Participant baseline demographics	Baseline
Treatment titration plan as described by the treating clinician	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
Participant baseline clinical characteristics	Baseline

Trial Locations

Locations (8)

Local Institution - 0003; 🇺🇸 Evanston, Illinois, United States

Local Institution - 0007; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 0004; 🇺🇸 Catonsville, Maryland, United States

Local Institution - 0002; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0005; 🇺🇸 Omaha, Nebraska, United States

Omaha Insomnia and Psychiatric Services; 🇺🇸 Omaha, Nebraska, United States

Local Institution - 0001; 🇺🇸 Belle Mead, New Jersey, United States

Local Institution - 0006; 🇺🇸 Fort Mill, South Carolina, United States