Pillar Clinical Research- Little Rock
RecruitingLittle Rock, Arkansas, 72204, United States
Site contacts (1)
Leslie Smith, Site 0017ContactPhone: 501-350-3285
CLINICAL STUDY · NCT07221877
A Study to Evaluate the Effect of KarXT on Urological Safety
RecruitingPhase 4Interventional
Sponsored by Bristol-Myers Squibb
- Condition
- Schizophrenia
- Study locations
- 16 reported sites
- Study updated
- 19 Oct 2026
- Source
- ClinicalTrials.gov
Overall study status is shown above. Individual hospitals may have a different recruitment status.
THE STUDY
About this study
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
Full official title
A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
PARTICIPATION
Who may participate
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex eligibility
- All sexes
- Healthy volunteers
- Not accepted
Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.
Full inclusion and exclusion 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
* 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
NEAR YOU
Study locations worldwide
16 sitesCheck the individual site’s status and contact the listed study team for current availability.
16 sites shown
Clinical Innovations, Inc. dba CITrials
RecruitingBellflower, California, 90706, United States
Site contacts (1)
Robert Bota, Site 0007ContactPhone: 562-748-4999
CenExel CNS - Garden Grove
RecruitingGarden Grove, California, 92845, United States
Site contacts (1)
David Walling, Site 0006ContactPhone: 714-799-7799
ATP Clinical Research
RecruitingOrange, California, 92866, United States
Site contacts (1)
Gustavo Alva, Site 0016ContactPhone: 949-354-5353
Local Institution - 0018
Not yet recruitingRedlands, California, 92373, United States
Site contacts (1)
Site 0018Contact
Collaborative Neuroscience Research, LLC
RecruitingTorrance, California, 90504, United States
Site contacts (1)
Lara Shirikjian, Site 0019ContactPhone: 310-523-4200
Local Institution - 0020
Not yet recruitingWest Covina, California, 91790, United States
Site contacts (1)
Site 0020Contact
Health Synergy Clinical Research
RecruitingBoynton Beach, Florida, 33426, United States
Site contacts (1)
Mohammad Nisar, Site 0004ContactPhone: 786-831-7303
Innovative Clinical Research
RecruitingLauderhill, Florida, 33319, United States
Site contacts (1)
Rishi Kakar, Site 0003ContactPhone: 786-512-4106
Uptown Research Institute
RecruitingChicago, Illinois, 60640, United States
Site contacts (1)
John Sonnenberg, Site 0005ContactPhone: 773-968-9868
Pillar Clinical Research -Chicago
RecruitingChicago, Illinois, 60641, United States
Site contacts (1)
Roueen Rafeyan, Site 0010ContactPhone: 312-865-6336
IMA Clinical Research Las Vegas
RecruitingLas Vegas, Nevada, 89102, United States
Site contacts (1)
Mustafa Rawaf, Site 0013ContactPhone: 702-527-7401
Hassman Research Institute Marlton Site
RecruitingMarlton, New Jersey, 08053, United States
Site contacts (1)
Elan Cohen, Site 0002ContactPhone: 267-981-8911
Adams Clinical Philadelphia
RecruitingPhiladelphia, Pennsylvania, 19104, United States
Site contacts (1)
Cassie Blanchard, Site 0014ContactPhone: 631-252-0769
Local Institution - 0001
Not yet recruitingAustin, Texas, 78754, United States
Site contacts (1)
Site 0001Contact
Adams Clinical Dallas
RecruitingDeSoto, Texas, 75115, United States
Site contacts (1)
Benji Kurian, Site 0015ContactPhone: 214-497-3151
No centres match this search. Try another hospital, city, state or country.
WHAT IS BEING STUDIED
Treatments and study groups
Interventions
Xanomeline/trospium chloride
Specified dose on specified days
Study groups: KarXT
Other names: KarXT, BMS-986510
Study groups
KarXT
Not reported.
Interventions: Drug: Xanomeline/trospium chloride
RESEARCH DETAILS
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Study model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants · Estimated
TIMELINE & MEASURES
Dates and outcomes
- Study started
- 20 Jan 2026 · Actual
- Primary completion
- 30 Dec 2027 · Estimated
- Study completion
- 30 Dec 2027 · Estimated
- First registered
- 28 Oct 2025 · Actual
- Last registry update
- 19 Oct 2026 · Actual
- Status last verified
- Oct 2026
Primary outcomes (2)
Change from baseline in voiding dynamics (Qmax) over time
Not reported.
Time frame: Up to 12 months
Change from baseline in post-void residual volume (PVR) over time
Not reported.
Time frame: Up to 12 months
Secondary outcomes (8)
Number of participants with a change from baseline in urinalysis parameters over time
Not reported.
Time frame: Up to 12 months
Change from baseline in IPSS over time
Not reported.
Time frame: Up to 12 months
Number of participants with electrocardiogram (ECG) abnormalities
Not reported.
Time frame: Up to 12 months
Number of participants with vital sign abnormalities
Not reported.
Time frame: Up to 12 months
Number of participants with Adverse Events (AEs)
Not reported.
Time frame: Up to 12 months
Number of participants with AEs of Special Interest (AESIs)
Not reported.
Time frame: Up to 12 months
Number of participants with Serious AEs (SAEs)
Not reported.
Time frame: Up to 12 months
Number of participants with suicidal ideation or behavior
Not reported.
Time frame: Up to 12 months
STUDY TEAM
Sponsor and contacts
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry
- Collaborators
- Not reported
- Organisation study ID
- CN012-0068
Central study contacts
BMS Clinical Trials Contact Center www.BMSClinicalTrials.comContactPhone: 855-907-3286Email: Clinical.Trials@bms.com
First line of the email MUST contain NCT # and Site #.Contact
Study officials
Bristol-Myers SquibbStudy director · Bristol-Myers Squibb
Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.
FURTHER READING
Results, documents and references
No results are posted in this registry record
This does not mean the study has no findings. Results may not yet have been submitted or published here.
No study documents are listed in this record.