RecruitingPhase not listed

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

Effectiveness and Adverse-effect Switch Evaluation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how KarXT (xanomeline and trospium chloride) is used in everyday care, how well it works, and its side effects. It is for adults in the United States with schizophrenia who recently started KarXT or plan to switch to it from other medicines.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 18 or older.
  • You, your caregiver, or your legal guardian must sign a study consent form.
  • Your treating clinician must decide that you can and are willing to take part in regular care and follow-up visits.
  • Your clinician must confirm schizophrenia or have decided to treat you with KarXT for schizophrenia before and apart from this study.
  • You must have started KarXT less than 16 weeks ago and plan to stop your prior schizophrenia medicines; OR you must have been on a stable schedule of one or more such medicines for at least 30 days before screening and plan to switch to KarXT.
  • The choice to switch medicines must be made by you or your clinician, not by the study. You may join while slowly reducing or stopping your prior medicines.
  • Other mental health medicines are allowed. Keeping their doses steady during the study is recommended.

Who can't join

  • You are not currently taking medicine for schizophrenia.
  • You used KarXT before but stopped it for any reason before the study starts.
  • You took part in a study that assigns a treatment or procedure within the past 30 days, or plan to do so during this study.
  • You have a known allergy to xanomeline or trospium chloride.
  • You have a history of, or high risk for, trouble emptying your bladder or stomach, moderate or severe liver problems, or narrow-angle glaucoma, a type of eye disease.
  • Your clinician thinks an unstable mental or physical health condition would make switching unsafe. If you switched or are switching in the hospital, you may join when discharged if you started KarXT less than 16 weeks ago.
  • You are pregnant, planning to become pregnant, or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (55)

AR

  • SanRo Clinical Research Group · Bryant, AR 72022Robert Wooten, Site 0009 · Study contactMore trials in Bryant

CA

FL

GA

IL

MI

MN

NC

NE

NV

NY

OH

OK

PA

TN

TX

VA