A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Pillar Clinical Research- Little Rock
RECRUITING
Little Rock
California
Local Institution - 0007
NOT_YET_RECRUITING
Bellflower
Local Institution - 0009
NOT_YET_RECRUITING
Culver City
CenExel CNS - Garden Grove
RECRUITING
Garden Grove
Local Institution - 0016
NOT_YET_RECRUITING
Orange
Florida
Local Institution - 0003
NOT_YET_RECRUITING
Miami
Local Institution - 0004
NOT_YET_RECRUITING
West Palm Beach
Illinois
Local Institution - 0010
NOT_YET_RECRUITING
Chicago
Uptown Research Institute
RECRUITING
Chicago
New Jersey
Hassman Research Institute Marlton Site
RECRUITING
Marlton
Nevada
Local Institution - 0013
NOT_YET_RECRUITING
Las Vegas
Pennsylvania
Adams Clinical Philadelphia
RECRUITING
Philadelphia
Texas
Local Institution - 0001
NOT_YET_RECRUITING
Austin
InSite Clinical Research
RECRUITING
Desoto
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 60
Treatments
Experimental: KarXT
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb