SchizophreniaPhase 3NCT07686263
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
A Phase 3 study testing Xanomeline/Trospium Chloride in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 54 sites in 7 countries.
Trial summary
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with 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?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 54 sitesin 7 countries
- Study dates
- 20 Aug 2026to 3 Mar 2029
- Phase
- Phase 3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
- Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
- Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
- Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
Show all 10Show fewer
- Item 3 (P3; hallucinatory behavior)
- Item 6 (P6; suspiciousness/persecution)
- Participant must have a CGI-S score of ≥ 4 at screening and Day -1
- Participant must have a BMI ≥ 18 and ≤ 40 kg/m2.
Who cannot join
- Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
- Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
- Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
- Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
- Participant must not have a history of treatment resistance to schizophrenia medications
- Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
54 sites in 7 countries. 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
54 sites in 7 countries
United States32 sites, 29 recruiting
- Not yet recruiting
Local Institution - 0190
Anaheim, California, 92805
Site 0190
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Elyssa Barron, Site 0166, 404-881-5800
- Not yet recruiting
Local Institution - 0049
Austin, Texas, 78754
Site 0049
- Recruiting
Clinical Innovations, Inc. dba CITrials
Bellflower, California, 90706
Gerald Maguire, Site 0040, 562-249-6956
- Recruiting
Pillar Clinical Research - Bentonville
Bentonville, Arkansas, 72712
Fayz Hudefi, Site 0154, 479-367-2688
- Recruiting
Health Synergy Clinical Research
Boynton Beach, Florida, 33426
Mohammad Nisar, Site 0044, 786-831-7303
- Not yet recruiting
Local Institution - 0067
Chicago, Illinois, 60640-5017
Site 0067
- Recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, 60641
Roueen Rafeyan, Site 0056, 312-865-6336
- Not yet recruiting
Local Institution - 0183
Cincinnati, Ohio, 45219
Site 0183
- Not yet recruiting
Local Institution - 0032
Culver City, California, 90230
Site 0032
- Not yet recruiting
Local Institution - 0192
Gaithersburg, Maryland, 20877
Site 0192
- Recruiting
Collaborative Neuroscience Research, LLC
Garden Grove, California, 92845
David Walling, Site 0037, 714-799-7799
- Recruiting
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Edwin Gomez, Site 0145, 954-604-3900
- Not yet recruiting
Local Institution - 0068
La Habra, California, 90631
Site 0068
- Not yet recruiting
Local Institution - 0128
Lemon Grove, California, 91945
Site 0128
- Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204
Leslie Smith, Site 0139, 501-350-3285
- Not yet recruiting
Local Institution - 0021
Little Rock, Arkansas, 72211
Site 0021
- Withdrawn
Local Institution - 0075
Miami, Florida, 33135
- Withdrawn
Local Institution - 0054
Miami Lakes, Florida, 33016
- Withdrawn
Local Institution - 0134
Miami Springs, Florida, 33166
- Not yet recruiting
Local Institution - 0187
Montclair, California, 91763
Site 0187
- Not yet recruiting
Local Institution - 0195
Oakland Park, Florida, 33334
Site 0195
- Not yet recruiting
Local Institution - 0047
Oklahoma City, Oklahoma, 73112
Site 0047
- Recruiting
NRC Research Institute
Orange, California, 92868
Tony Ortiz, Site 0151, 714-289-1100
- Not yet recruiting
Local Institution - 0030
Pico Rivera, California, 90660
Site 0030
- Not yet recruiting
Local Institution - 0185
Redlands, California, 92373
Site 0185
- Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
Scott Bartley, Site 0133, 214-396-4844
- Not yet recruiting
Local Institution - 0186
Riverside, California, 92506
Site 0186
- Not yet recruiting
Local Institution - 0153
Rogers, Arkansas, 72758
Site 0153
- Not yet recruiting
Local Institution - 0070
Sandy Springs, Georgia, 30328
Site 0070
- Not yet recruiting
Local Institution - 0189
Savannah, Georgia, 31405
Site 0189
- Not yet recruiting
Local Institution - 0193
Torrance, California, 90504
Site 0193
Romania8 sites, 8 recruiting
- Not yet recruiting
Local Institution - 0104
Brașov, Brăila County, 500123
Site 0104
- Not yet recruiting
Local Institution - 0103
Bucharest, Bucharest, 041914
Site 0103
- Not yet recruiting
Local Institution - 0105
Bucharest, Bucharest, 041914
Site 0105
- Not yet recruiting
Local Institution - 0107
Bucharest, Bucharest, 041914
Site 0107
- Not yet recruiting
Local Institution - 0110
Bucharest, Bucharest, 041914
Site 0110
- Not yet recruiting
Local Institution - 0174
Bucharest, 011241
Site 0174
- Not yet recruiting
Local Institution - 0106
Bucharest, 41914
Site 0106
- Not yet recruiting
Local Institution - 0109
Bucharest, 41914
Site 0109
Argentina5 sites, 3 recruiting
- Withdrawn
Local Institution - 0143
Buenos Aires, C1199ABB
- Not yet recruiting
Local Institution - 0002
Córdoba, 5000
Site 0002
- Not yet recruiting
Local Institution - 0197
Córdoba, 5003
Site 0197
- Withdrawn
Local Institution - 0175
Río Cuarto, Córdoba Province, 5800
- Recruiting
Clinica El Jardin
Santiago del Estero, 4200
Gaston Noriega, Site 0144, +5493854027710
Poland3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0122
Bialystok, Podlaskie Voivodeship, 15-272
Site 0122
- Not yet recruiting
Local Institution - 0001
Poznan, 60-744
Site 0001
- Not yet recruiting
Local Institution - 0123
Warsaw, Masovian Voivodeship, 02-957
Site 0123
Spain3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0112
Barcelona, Barcelona [Barcelona], 08003
Site 0112
- Not yet recruiting
Local Institution - 0167
Valladolid, 47012
Site 0167
- Not yet recruiting
Local Institution - 0181
Zamora, 49021
Site 0181
Czechia2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0162
Brno, 625 00
Site 0162
- Not yet recruiting
Local Institution - 0014
Klecany, 25067
Site 0014
Bulgaria1 site, 1 recruiting
- Not yet recruiting
Local Institution - 0191
Novi Iskar, 1282
Site 0191
About this study
Official title: A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
- Conditions
- Schizophrenia
- Being tested
- Xanomeline/Trospium Chloride, Placebo
- Keywords
- KarXT, Cobenfy
- 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
PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT | Experimental | Not described Receives: Drug: Xanomeline/Trospium Chloride |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From Randomization to the First Relapse Event
Measured: Up to approximately Week 43
Secondary outcomes (6)
Time to Discontinuation During Double-blind Treatment Period
Measured: Approximately From Week 18 to 43
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately Week 45
Number of Participants With Adverse Events of Special Interest (AESIs)
Measured: Up to approximately Week 45
Number of Participants With Procholinergic Symptoms
Measured: Up to approximately Week 45
Number of Participants With Anticholinergic Symptoms
Measured: Up to approximately Week 45
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to approximately Week 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start20 Aug 2026
- Primary completion3 Mar 2029 (estimated)
- Study completion3 Mar 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- 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
- NCT07686263
- Sponsor's protocol ID
- CN012-0006
- Other IDs
- 2025-523664-20, U1111-1327-7599, 2025
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-blind, Placebo-controlled Randomized Withdrawal Maintenance Trial of KarXT Treatment in Participants With Schizophrenia
- ClinicalTrials.gov ID
- NCT07686263
- Acronym / sponsor ID
- CN012-0006
- Conditions
- Schizophrenia
- Keywords
- KarXT, Cobenfy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- 3 Mar 2029 (estimated)
- Study completion
- 3 Mar 2029 (estimated)
- First posted
- 7 Jul 2026 (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 the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KarXT | Experimental | Drug: Xanomeline/Trospium Chloride |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening.
- Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date.
- Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1.
- Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1:
- Participant must have a CGI-S score of ≥ 4 at screening and Day -1
Key exclusion criteria (7 listed)
- Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening
- Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia.
- Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS).
- Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening.
- Participant must not have a history of treatment resistance to schizophrenia medications
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/Trospium ChlorideAlso: KarXT, BMS-986510Specified dose on specified days | Drug | KarXT |
| PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Time From Randomization to the First Relapse Event
Time frame: Up to approximately Week 43
6 secondary outcomes
Time to Discontinuation During Double-blind Treatment Period
Time frame: Approximately From Week 18 to 43
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately Week 45
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately Week 45
Number of Participants With Procholinergic Symptoms
Time frame: Up to approximately Week 45
Number of Participants With Anticholinergic Symptoms
Time frame: Up to approximately Week 45
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately Week 45
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 Oct 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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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
54 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xanomeline/Trospium Chloride in people with Schizophrenia, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 54 sites in 7 countries.
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 10 inclusion and 7 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Romania, Argentina, Poland, Spain and 2 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time From Randomization to the First Relapse Event (time frame: Up to approximately Week 43). 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 Oct 2026.