Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)
ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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.
Disqualifiers
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.
Trial population
The study population will include adults diagnosed with schizophrenia who have switched or plan to switch from prior antipsychotic treatment to xanomeline and trospium chloride (KarXT)
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Xanomeline and trospium chloride (KarXT)
DrugAccording to the product label
Treatment groups
1,500 Participants
are divided into 1 treatment groupGroup A: Group 11 intervention
Trial outcomes
Primary outcomes
1
Treatment titration and switch regimens as described by the prescribing clinician
Time frame
Baseline and up to 20 weeksSecondary outcomes
1
Adverse events (AEs)
Time frame
Baseline and up to 20 weeks2
Change in participant weight
Time frame
Baseline and up to 20 weeks3
Clinical Global Impressions - Improvement (CGI-I) score
Time frame
Baseline and up to 20 weeks4
Number of schizophrenia-related relapses (defined as schizophrenia-related emergency department visits and/or hospitalizations and symptoms
Time frame
Baseline and up to 20 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov