A Study to Evaluate the Effect of KarXT on Urological Safety

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: Xanomeline/trospium chloride

• Registration Number: NCT07221877
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-13
• Study First Submitted QC: 2025-10-24
• Last Update Submitted: 2025-10-24
• Study First Posted: 2025-10-28
• Last Update Posted: 2025-10-28
• Study Start: 2026-01-21
• Primary Completion: 2027-12-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
KarXT	Xanomeline/trospium chloride	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in voiding dynamics (Qmax) over time	Up to 12 months
Change from baseline in post-void residual volume (PVR) over time	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Number of participants with a change from baseline in urinalysis parameters over time	Up to 12 months
Number of participants with vital sign abnormalities	Up to 12 months
Number of participants with Adverse Events (AEs)	Up to 12 months
Change from baseline in IPSS over time	Up to 12 months
Number of participants with electrocardiogram (ECG) abnormalities	Up to 12 months
Number of participants with AEs of Special Interest (AESIs)	Up to 12 months
Number of participants with Serious AEs (SAEs)	Up to 12 months
Number of participants with suicidal ideation or behavior	Up to 12 months

Trial Locations

Locations (16)

Local Institution - 0017; 🇺🇸 Little Rock, Arkansas, United States

Local Institution - 0007; 🇺🇸 Bellflower, California, United States

Local Institution - 0009; 🇺🇸 Culver City, California, United States

Local Institution - 0006; 🇺🇸 Los Alamitos, California, United States

Local Institution - 0016; 🇺🇸 Orange, California, United States

Local Institution - 0003; 🇺🇸 Miami, Florida, United States

Local Institution - 0008; 🇺🇸 Miami, Florida, United States

Local Institution - 0004; 🇺🇸 Stuart, Florida, United States

Local Institution - 0005; 🇺🇸 Chicago, Illinois, United States

Local Institution - 0010; 🇺🇸 Chicago, Illinois, United States

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