Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

Official title

Effectiveness and Adverse-effect Switch Evaluation

Overview

The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States

Interventions

• Drug Xanomeline and trospium chloride (KarXT)
  According to the product label

Primary outcome measures

• Treatment titration and switch regimens as described by the prescribing clinician [Time frame: Baseline and up to 20 weeks]

Secondary outcome measures (12)

• Adverse events (AEs) [Time frame: Baseline and up to 20 weeks]
• Change in participant weight [Time frame: Baseline and up to 20 weeks]
• Clinical Global Impressions - Improvement (CGI-I) score [Time frame: Baseline and up to 20 weeks]
• Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms [Time frame: Baseline and up to 20 weeks]
• Continuation of treatment with xanomeline and trospium chloride (KarXT) at End of Study [Time frame: Baseline and up to 20 weeks]
• Number of participants who discontinue treatment, time to discontinuation, and reasons for discontinuation [Time frame: Baseline and up to 20 weeks]
• Number of participants using antiemetic treatment by type, duration, and resolution of event for xanomeline and trospium chloride (KarXT) related gastro-intestinal (GI) symptoms [Time frame: Baseline and up to 20 weeks]
• Date of first xanomeline and trospium chloride (KarXT) treatment [Time frame: Baseline]
• Participant age [Time frame: Baseline]
• Participant sex [Time frame: Baseline]
• Participant race [Time frame: Baseline]
• Participant ethnicity [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

• Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.
• Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.
• Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:

• Be within <16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR
• On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.
• Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.

Exclusion criteria

• Prior use of KarXT that has been discontinued for any reason prior to Baseline.
• Participation in an interventional study within the last 30 days or plans to participate in an interventional study at the time of eligibility or baseline through the study period.
• Known hypersensitivity to xanomeline or trospium chloride, or history or high risk of urinary retention, gastric retention, moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment, or narrow-angle glaucoma.
• In the opinion of the treating clinician, unstable psychiatric or medical conditions that would prevent the participant from safely switching to KarXT. Hospitalized individuals who have been switched to KarXT or are switching treatment to KarXT are permitted to be enrolled at discharge if they are < 16 weeks from initiation of KarXT.
• Participants who are pregnant, planning to become pregnant, or breastfeeding.

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 · 52 centers

• SanRo Clinical Research Group — Bryant
• Local Institution - 0047 — Anaheim
• Local Institution - 0003 — Anaheim
• Local Institution - 0039 — Chino
• Local Institution - 0012 — La Palma
• Local Institution - 0043 — Oceanside
• Local Institution - 0028 — Stanford
• Envision Trials LLC — Bonita Springs
• … and 44 more centers

Identifiers

NCT: NCT07379827 · CN012-0134

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗