A Phase 3 interventional study of Xanomeline/Trospium Chloride and Placebo in Schizophrenia, sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Recruiting at 54 sites in 7 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 472 is above the median of 71 across 2,944 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Karuna Therapeutics, Inc., a Bristol Myers Squibb company is the lead sponsor of 17 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
First submitted after Karuna Therapeutics, Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Xanomeline/Trospium Chloride
Drug: Placebo
Drug pages: Xanomeline · Trospium chloride
Specified dose on specified days
Also known as: KarXT, BMS-986510
Specified dose on specified days
Time From Randomization to the First Relapse Event
Time frame: Up to approximately Week 43
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
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Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Aug 2026 (actual). Primary completion is estimated for Mar 2029, 30 months after the start.
Of 99 industry-sponsored phase 3 interventional studies under Schizophrenia, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 41. This study's planned 30 months is close to that.
Counting every sponsor, half of 113 studies reached it within 32 months; a quarter within 20 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Xanomeline · Trospium chloride
Karuna Therapeutics, Inc., a Bristol Myers Squibb company →