Recruiting NCT07221877

A Study to Evaluate the Effect of KarXT on Urological Safety

Phase IV Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Xanomeline/trospium chloride.
Who it may be relevant to: Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety

The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.

Change from baseline in voiding dynamics (Qmax) over time [Time frame: Up to 12 months]
Change from baseline in post-void residual volume (PVR) over time [Time frame: Up to 12 months]

Secondary outcome measures (8)

Number of participants with a change from baseline in urinalysis parameters over time [Time frame: Up to 12 months]
Change from baseline in IPSS over time [Time frame: Up to 12 months]
Number of participants with electrocardiogram (ECG) abnormalities [Time frame: Up to 12 months]
Number of participants with vital sign abnormalities [Time frame: Up to 12 months]
Number of participants with Adverse Events (AEs) [Time frame: Up to 12 months]
Number of participants with AEs of Special Interest (AESIs) [Time frame: Up to 12 months]
Number of participants with Serious AEs (SAEs) [Time frame: Up to 12 months]
Number of participants with suicidal ideation or behavior [Time frame: Up to 12 months]

Male and Female participants (age 18 to 65 years of age, with a primary diagnosis of schizophrenia based on psychiatric evaluation (DSM-5) and confirmed by MINI (v 7.0.2).
Participants must have a PANSS total score ≤ 80 and CGI-S score ≤ 4, at screening and baseline, and a BMI ≥18 and ≤ 40 kg/m2.
Participants must be willing and able to discontinue all antipsychotic medications prior to the baseline visit and be willing and able to comply with protocol requirements.

Participants with newly diagnosed schizophrenia, any other DSM-5 disorder diagnosed within the past 12 months, alcohol or drug use disorder within the past 12 months, history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
Participants at risk for suicidal behavior, as well as individuals who are pregnant or breastfeeding, will be excluded from the study.
Other protocol-defined Inclusion/Exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 13 centers

NCT: NCT07221877 · CN012-0068