SchizophreniaPhase 4NCT07221877
A Study to Evaluate the Effect of KarXT on Urological Safety
A Phase 4 study testing Xanomeline/trospium chloride in people with Schizophrenia, run by Bristol-Myers Squibb at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Xanomeline/trospium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 16 sitesUnited States
- Study dates
- 20 Jan 2026to 30 Dec 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
16 sites in 1 country
United States16 sites, 16 recruiting
- Not yet recruiting
Local Institution - 0001
Austin, Texas, 78754
Site 0001
- Recruiting
Clinical Innovations, Inc. dba CITrials
Bellflower, California, 90706
Robert Bota, Site 0007, 562-748-4999
- Recruiting
Health Synergy Clinical Research
Boynton Beach, Florida, 33426
Mohammad Nisar, Site 0004, 786-831-7303
- Recruiting
Uptown Research Institute
Chicago, Illinois, 60640
John Sonnenberg, Site 0005, 773-968-9868
- Recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, 60641
Roueen Rafeyan, Site 0010, 312-865-6336
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Benji Kurian, Site 0015, 214-497-3151
- Recruiting
CenExel CNS - Garden Grove
Garden Grove, California, 92845
David Walling, Site 0006, 714-799-7799
- Recruiting
IMA Clinical Research Las Vegas
Las Vegas, Nevada, 89102
Mustafa Rawaf, Site 0013, 702-527-7401
- Recruiting
Innovative Clinical Research
Lauderhill, Florida, 33319
Rishi Kakar, Site 0003, 786-512-4106
- Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204
Leslie Smith, Site 0017, 501-350-3285
- Recruiting
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053
Elan Cohen, Site 0002, 267-981-8911
- Recruiting
ATP Clinical Research
Orange, California, 92866
Gustavo Alva, Site 0016, 949-354-5353
- Recruiting
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, 19104
Cassie Blanchard, Site 0014, 631-252-0769
- Not yet recruiting
Local Institution - 0018
Redlands, California, 92373
Site 0018
- Recruiting
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
Lara Shirikjian, Site 0019, 310-523-4200
- Not yet recruiting
Local Institution - 0020
West Covina, California, 91790
Site 0020
About this study
Official title: A 12-month Open-label, Phase 4 Multicenter Safety Study to Evaluate the Effect of KarXT on Voiding Dynamics and Urological Safety
The purpose of this study is to characterize the effect of KarXT on voiding dynamics and urological safety in participants with DSM-5 schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Xanomeline/trospium chloride
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline/trospium chlorideDrug
Also called KarXT, BMS-986510
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT | Experimental | Not described Receives: Drug: Xanomeline/trospium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in voiding dynamics (Qmax) over time
Measured: Up to 12 months
Change from baseline in post-void residual volume (PVR) over time
Measured: Up to 12 months
Secondary outcomes (8)
Number of participants with a change from baseline in urinalysis parameters over time
Measured: Up to 12 months
Change from baseline in IPSS over time
Measured: Up to 12 months
Number of participants with electrocardiogram (ECG) abnormalities
Measured: Up to 12 months
Number of participants with vital sign abnormalities
Measured: Up to 12 months
Number of participants with Adverse Events (AEs)
Measured: Up to 12 months
Number of participants with AEs of Special Interest (AESIs)
Measured: Up to 12 months
Number of participants with Serious AEs (SAEs)
Measured: Up to 12 months
Number of participants with suicidal ideation or behavior
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start20 Jan 2026
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221877
- Sponsor's protocol ID
- CN012-0068
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html