Real-world Patient Characteristics, Treatment Patterns, and Healthcare Utilization Among KarXT Users

NCT07571148 | Active Not Recruiting FDA Drug

• 1 other identifier: CN012-0080
• Study Type: observational
• Target: 6,876
• Locations: 1 country
• Sites: 1

Brief Summary

This study uses existing health records and insurance claims data to understand how adults in the United States are treated with KarXT, a medication for schizophrenia. It will describe who receives KarXT, how it is used in real-world practice, and how often healthcare services such as hospital visits are used. It will also explore information recorded by clinicians about schizophrenia symptoms

Conditions

Schizophrenia

Keywords

Schizophrenia; KarXT; xanomeline; trospium;

Outcome Measures

Primary Outcomes (9)

• Number of all-cause and schizophrenia-related healthcare encounters per participant

  Number of inpatient admissions, emergency room visits, urgent care visits, and outpatient visits identified from claims and EHR data. Schizophrenia-related encounters are defined as those with a primary diagnosis of schizophrenia using ICD-10-CM codes.

  Baseline and up to 6 months

• Number of participants adherent to KarXT (proportion of days covered ≥80%)

  Adherence measured using proportion of days covered (PDC), defined as total days of KarXT supply divided by total number of days in the follow-up period. Participants with PDC ≥80% are classified as adherent. Reported as number and percentage of participants meeting adherence criteria.

  Baseline and up to 6 months

• Time to discontinuation of KarXT

  Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply.

  Baseline and up to 6 months

• KarXT initial dose (index dose)

  Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack)

  Baseline

• Number of of participants with dose increases or decreases

  Baseline and up to 6 months

• Number of participants using concomitant antipsychotic and anticholinergic medications

  Baseline and up to 6 months

• Number of participants with comorbidities

  Baseline and up to 6 months

• Number of participants with gastrointestinal adverse events

  Baseline and up to 6 months

• Number of participants with documented schizophrenia symptoms

  Presence of positive and negative schizophrenia symptoms identified using natural language processing (NLP) of unstructured clinical notes, including hallucinations, delusions, disorganized thought, amotivation, avolition, anhedonia, asociality, alogia, and blunted affect.

  Baseline and up to 6 months

Study Arms (1)

Adults treated with KarXT

Adults aged ≥18 years in the United States with at least one prescription for KarXT on or after September 24, 2024 identified in linked electronic health record and claims data.

Drug: KarXT (xanomeline and trospium)

Interventions

KarXT (xanomeline and trospium) DRUG

As per product label

Adults treated with KarXT

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

Adults diagnosed with schizophrenia in the United States with a prescription for KarXT identified in linked electronic health record and administrative claims data.

You may qualify if:

• Participants in the Veradigm EHR/claims-linked database with evidence of treatment with KarXT on or after September 24, 2024
• Earliest KarXT treatment date = index date
• Aged 18 years or older on index date

You may not qualify if:

• Not applicable

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Veradigm

Chicago, Illinois, 60654, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Schizophrenia

Interventions

xanomeline; trospium chloride

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: January 16, 2026
• Primary Completion: March 25, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)