SchizophreniaNCT07101094
Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
An observational study of Schizophrenia, run by Bristol-Myers Squibb at 20 sites in United States.
Trial summary
The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- xanomeline and trospium chloride (X/T) therapy
- How many people
- 300 participants
- Where
- 20 sitesUnited States
- Study dates
- 22 Sep 2025to 14 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.
Who may be able to join
- Aged ≥18 years at index date.
- Have a confirmed diagnosis of schizophrenia before index date.
- Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.
- Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
- Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).
- English or Spanish speaking.
Who cannot join
- Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.
- Evidence of use of XT prior to time of eligibility screening.
Trial locations and contacts
20 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
20 sites in 1 country
United States20 sites, 16 recruiting
- Recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Frederick Nucifora, Site 0007, 215-620-3793
- Withdrawn
Local Institution - 0017
Bel Air, Maryland, 21015
- Recruiting
Hackensack Meridian Health - Carrier Clinic
Belle Mead, New Jersey, 08502
Stacy Doumas, Site 0001
- Completed
Local Institution - 0008
Belmont, Massachusetts, 02478-1064
- Recruiting
Boston Medical Center
Boston, Massachusetts, 02118
Hannah Brown, Site 0002, 617-638-8141
- Withdrawn
Local Institution - 0004
Catonsville, Maryland, 21228
- Recruiting
Haracec Clinical Research
El Paso, Texas, 79902
Aghaegbulam Uga, Site 0012
- Recruiting
Evanston Hospital
Evanston, Illinois, 60201
Joshua Straus, Site 0003, 312-399-3795
- Recruiting
Continuum Health Providers
Fort Mill, South Carolina, 29708
Brian Mika, Site 0006
- Not yet recruiting
Local Institution - 0020
Grand Island, Nebraska, 68803
Site 0020
- Recruiting
New Dawn Psychiatric Services, PLLC
Kinston, North Carolina, 28501
Punitha Rathnam, Site 0016, 252-686-8091
- Recruiting
C-Trilogy Outreach
Longview, Texas, 75601
Tracy Hicks, Site 0013, 903-576-2629
- Not yet recruiting
Local Institution - 0019
Miami, Florida, 33176
Site 0019
- Recruiting
Radial - Manhattan
New York, New York, 10018
Owen Muir, Site 0015, 929-260-5003
- Recruiting
Omaha Insomnia and Psychiatric Services
Omaha, Nebraska, 68144
Vithya Selvaraj, Site 0005, 402-991-9630
- Recruiting
ATP Clinical Research - Costa Mesa
Orange, California, 92866
Gustavo Alva, Site 0009, 714-277-4472
- Recruiting
New Dimension Group
Rose Hill, North Carolina, 28458
Constance Olatidoye, Site 0018, 910-233-2813
- Recruiting
Lumos Clinical Research Center
San Jose, California, 95124
Sarbani Maitra, Site 0010, 408-668-2712
- Completed
Local Institution - 0011
South Dartmouth, Massachusetts, 02747
- Recruiting
Westlake Brain Health
Westlake, Ohio, 44145
Abdelrahman Abdelaziz, Site 0014, 317-560-2391
About this study
Official title: Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy
- Conditions
- Schizophrenia
- Being tested
- xanomeline and trospium chloride (X/T) therapy
- Keywords
- Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xanomeline and trospium chloride (X/T) therapyDrug
According to the product label
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving xanomeline and trospium chloride (X/T) therapy | Not described Receives: Drug: xanomeline and trospium chloride (X/T) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant medication preference as assessed by the Preference of Medication (POM) questionnaire
Measured: Month 1, Month 3, Month 6
Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)
Measured: Baseline, Month 1, Month 3, Month 6
Secondary outcomes (8)
Treatment titration plan as described by the treating clinician
Measured: Baseline, Month 1, Month 3, Month 6
Treatment switch plan as described by the treating physician
Measured: Baseline, Month 1, Month 3, Month 6
Treatment dose prescribed
Measured: Baseline, Month 1, Month 3, Month 6
Concomitant medication prescribed
Measured: Baseline, Month 1, Month 3, Month 6
Number of participants who are prescribed a treatment dose change
Measured: Month 1, Month 3, Month 6
Reasons for treatment discontinuation
Measured: Month 1, Month 3, Month 6
Participant baseline clinical characteristics
Measured: Baseline
Participant baseline demographics
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start22 Sep 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion14 May 2029 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 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
- NCT07101094
- Sponsor's protocol ID
- CN012-0066
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)
- ClinicalTrials.gov ID
- NCT07101094
- Acronym / sponsor ID
- CN012-0066
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 14 May 2029 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving xanomeline and trospium chloride (X/T) therapy | – | Drug: xanomeline and trospium chloride (X/T) therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.
Key inclusion criteria (6 listed)
- Aged ≥18 years at index date.
- Have a confirmed diagnosis of schizophrenia before index date.
- Receipt of an initial prescription order for xanomeline and trospium chloride (XT) and plan to fill and initiate such therapy.
- Provide a signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written informed consent form (ICF) in accordance with regulatory, local, and institutional guidelines.
- Agree to use an electronic device to record, or provide paper entry of, patient-reported outcomes (in English or Spanish).
Key exclusion criteria (2 listed)
- Participation in an interventional study within the last 30 days or plan to participate in such study at the time of eligibility screening.
- Evidence of use of XT prior to time of eligibility screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| xanomeline and trospium chloride (X/T) therapyAccording to the product label | Drug | Participants receiving xanomeline and trospium chloride (X/T) therapy |
Primary outcome
Participant medication preference as assessed by the Preference of Medication (POM) questionnaire
Time frame: Month 1, Month 3, Month 6
Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ)
Time frame: Baseline, Month 1, Month 3, Month 6
8 secondary outcomes
Treatment titration plan as described by the treating clinician
Time frame: Baseline, Month 1, Month 3, Month 6
Treatment switch plan as described by the treating physician
Time frame: Baseline, Month 1, Month 3, Month 6
Treatment dose prescribed
Time frame: Baseline, Month 1, Month 3, Month 6
Concomitant medication prescribed
Time frame: Baseline, Month 1, Month 3, Month 6
Number of participants who are prescribed a treatment dose change
Time frame: Month 1, Month 3, Month 6
Reasons for treatment discontinuation
Time frame: Month 1, Month 3, Month 6
Participant baseline clinical characteristics
Time frame: Baseline
Participant baseline demographics
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol Myers Squibb study director
Bristol-Myers Squibb
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Bristol-Myers Squibb at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant medication preference as assessed by the Preference of Medication (POM) questionnaire (time frame: Month 1, Month 3, Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.