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

Condition(s) studied

Investigational drug(s) / intervention(s)

KarXT (xanomeline and trospium): As per product label

Study 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

Eligibility

Primary outcome measure(s)

• Number of all-cause and schizophrenia-related healthcare encounters per participant — Baseline and up to 6 months
  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.
• Number of participants adherent to KarXT (proportion of days covered ≥80%) — Baseline and up to 6 months
  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.
• Time to discontinuation of KarXT — Baseline and up to 6 months
  Time from index date (first KarXT prescription) to discontinuation, defined as a gap of ≥45 consecutive days without KarXT supply.
• KarXT initial dose (index dose) — Baseline
  Distribution of index dose (50 mg/20 mg, 100 mg/20 mg, 125 mg/30 mg, or starter pack)
• 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 — Baseline and up to 6 months
  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.

Trial sites (1)

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