A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
Bristol-Myers Squibb
Summary
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 diagno…
Interventions
- DrugXanomeline/trospium chloride
Specified dose on specified days
Locations (14)
- Pillar Clinical Research- Little RockLittle Rock, Arkansas
- Clinical Innovations, Inc. dba CITrialsBellflower, California
- Local Institution - 0009Culver City, California
- CenExel CNS - Garden GroveGarden Grove, California
- ATP Clinical ResearchOrange, California
- Local Institution - 0003Miami, Florida