Xanomeline and trospium chloride (KarXT) treatment for adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational U.S.-based registry describing real-world treatment patterns, effectiveness, and adverse events in adults with clinician-diagnosed schizophrenia who initiate or are on a stable KarXT regimen. Adults aged 18 and older who start KarXT within about 16 weeks or who are on a stable regimen per the treating clinician can enroll after giving informed consent. Data collection will rely on routine clinical visits and will capture medication changes, symptom measures documented in care, and reported side effects. There is no randomization or extra investigational procedures beyond standard clinical practice, and the study is sponsored by Bristol-Myers Squibb at several local clinical sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• SanRo Clinical Research Group
  Bryant, Arkansas, United States Recruiting
• Pamoja Advanced Nursing Practice
  Anaheim, California, United States Recruiting
• Inland Psychiatric Medical Group (IPMG)-Chino
  Chino, California, United States Recruiting
• Envision Trials LLC
  Bonita Springs, Florida, United States Recruiting
• Galiz Research
  Hialeah, Florida, United States Recruiting
• New Access Research & Medical Services Inc - Kendall
  Kendall, Florida, United States Recruiting

+18 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.