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RecruitingPhase 4

A Study to Evaluate the Effect of KarXT on Urological Safety

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

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 to 65 Years
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 tests how KarXT affects urination and the safety of the urinary system. It is for adults ages 18 to 65 with schizophrenia.

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

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

Eligibility

Who can join

  • Be age 18 to 65, with schizophrenia as your main diagnosis, confirmed by mental health exams.
  • Have symptom scores of 80 or less on PANSS and 4 or less on CGI-S at screening and the starting visit. These scales measure how severe your symptoms are.
  • Have a body mass index (BMI) from 18 to 40. BMI is a measure based on height and weight.
  • Be willing and able to stop all antipsychotic medicines before the starting visit, as directed by the study team.
  • Be willing and able to follow the study rules.

Who can't join

  • Have newly diagnosed schizophrenia.
  • Have another mental health disorder diagnosed within the past 12 months.
  • Have had an alcohol or drug use disorder within the past 12 months.
  • Have a current or past serious health condition that could make the study unsafe for you or affect the results.
  • Be at risk of suicidal behavior.
  • Be pregnant or breastfeeding.
  • Other study rules may also affect whether you can join.

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

Official eligibility criteria

Inclusion Criteria * 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. Exclusion Criteria * 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

Study sites (16)

AR

CA

FL

IL

NJ

NV

PA

TX