Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
Recruiting · NCT07379827 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
Xanomeline and trospium chloride (KarXT)
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
55 locations listed across 17 US states.
- SanRo Clinical Research Group - Bryant, Arkansas, United States
- Pamoja Advanced Nursing Practice - Anaheim, California, United States
- Local Institution - 0003 - Anaheim, California, United States
- Inland Psychiatric Medical Group (IPMG)-Chino - Chino, California, United States
- Local Institution - 0012 - La Palma, California, United States
- Local Institution - 0043 - Oceanside, California, United States
- Local Institution - 0028 - Stanford, California, United States
- Envision Trials LLC - Bonita Springs, Florida, United States
- Galiz Research - Hialeah, Florida, United States
- Local Institution - 0030 - Homestead, Florida, United States
- New Access Research & Medical Services Inc - Kendall - Kendall, Florida, United States
- Local Institution - 0032 - Miami, Florida, United States
- Banyan Behavioal Care Program - CSU - Miami, Florida, United States
- Local Institution - 0007 - Miami, Florida, United States
- BioResearch Partner - Miami - Miami, Florida, United States
- Medical Research of Central Florida - Orange City, Florida, United States
- Local Institution - 0040 - Orlando, Florida, United States
- Emory University. - Atlanta, Georgia, United States
- Local Institution - 0049 - Austell, Georgia, United States
- Local Institution - 0044 - Marietta, Georgia, United States
- Local Institution - 0046 - Crystal Lake, Illinois, United States
- Amr Conventions Research - Illinois - Warrenville, Illinois, United States
- Local Institution - 0014 - Bloomfield Township, Michigan, United States
- Local Institution - 0036 - Detroit, Michigan, United States
- Local Institution - 0034 - Apple Valley, Minnesota, United States
- Local Institution - 0054 - Duluth, Minnesota, United States
- Local Institution - 0041 - Lincoln, Nebraska, United States
- Local Institution - 0055 - Las Vegas, Nevada, United States
- Local Institution - 0037 - Buffalo, New York, United States
- Local Institution - 0004 - Monsey, New York, United States
- Local Institution - 0038 - Rochester, New York, United States
- Local Institution - 0020 - White Plains, New York, United States
- Magnolia Clinical Research, LLC - Cary, North Carolina, United States
- PPD Virtual - PPD - US - Wilmington, North Carolina, United States
- Local Institution - 0031 - Mason, Ohio, United States
- The Rivus Wellness & Research Institute - Oklahoma City, Oklahoma, United States
- Local Institution - 0052 - Tulsa, Oklahoma, United States
- Perelman School of Medicine at the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- Local Institution - 0053 - State College, Pennsylvania, United States
- Local Institution - 0051 - Cordova, Tennessee, United States
- Psychiatric Consultants, Pc - Franklin, Tennessee, United States
- Local Institution - 0016 - Austin, Texas, United States
- Local Institution - 0050 - Dallas, Texas, United States
- Local Institution - 0021 - Fort Worth, Texas, United States
- Local Institution - 0033 - Houston, Texas, United States
- Local Institution - 0026 - Houston, Texas, United States
- Local Institution - 0022 - Houston, Texas, United States
- Local Institution - 0010 - Houston, Texas, United States
- Pioneer Research Solutions, Inc. - Houston, Texas, United States
- Local Institution - 0017 - Irving, Texas, United States
- Local Institution - 0013 - McKinney, Texas, United States
- Perceptive Pharma Research - Richmond, Texas, United States
- UT Health San Antonio - Behavioral Health and Wellness Center - San Antonio, Texas, United States
- Local Institution - 0018 - Stafford, Texas, United States
- Local Institution - 0045 - Petersburg, Virginia, United States