RECRUITINGPhase 4INTERVENTIONAL
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
About This Trial
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Who May Be Eligible (Plain English)
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Xanomeline/trospium chloride
Specified dose on specified days
Locations (14)
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Local Institution - 0007
Bellflower, California, United States
Local Institution - 0009
Culver City, California, United States
CenExel CNS - Garden Grove
Garden Grove, California, United States
Local Institution - 0016
Orange, California, United States
Local Institution - 0003
Miami, Florida, United States
Local Institution - 0004
West Palm Beach, Florida, United States
Uptown Research Institute
Chicago, Illinois, United States
Local Institution - 0010
Chicago, Illinois, United States
Local Institution - 0013
Las Vegas, Nevada, United States
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States
Local Institution - 0001
Austin, Texas, United States
InSite Clinical Research
DeSoto, Texas, United States