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Recruiting NCT07101094

Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

— Observational Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: xanomeline and trospium chloride (X/T) therapy.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

Overview

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

Interventions

  • Drug xanomeline and trospium chloride (X/T) therapy
    According to the product label

Primary outcome measures

  • Participant medication preference as assessed by the Preference of Medication (POM) questionnaire [Time frame: Month 1, Month 3, Month 6]
  • Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ) [Time frame: Baseline, Month 1, Month 3, Month 6]
Secondary outcome measures (8)
  • Treatment titration plan as described by the treating clinician [Time frame: Baseline, Month 1, Month 3, Month 6]
  • Treatment switch plan as described by the treating physician [Time frame: Baseline, Month 1, Month 3, Month 6]
  • Treatment dose prescribed [Time frame: Baseline, Month 1, Month 3, Month 6]
  • Concomitant medication prescribed [Time frame: Baseline, Month 1, Month 3, Month 6]
  • Number of participants who are prescribed a treatment dose change [Time frame: Month 1, Month 3, Month 6]
  • Reasons for treatment discontinuation [Time frame: Month 1, Month 3, Month 6]
  • Participant baseline clinical characteristics [Time frame: Baseline]
  • Participant baseline demographics [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 18 centers
  • Local Institution - 0009 — Orange
  • Lumos Clinical Research Center — San Jose
  • Evanston Hospital — Evanston
  • The Johns Hopkins Hospital — Baltimore
  • Local Institution - 0017 — Bel Air
  • Local Institution - 0004 — Catonsville
  • Local Institution - 0008 — Belmont
  • Boston Medical Center — Boston
  • … and 10 more centers

Identifiers

NCT: NCT07101094 · CN012-0066

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗