A Phase 3 interventional study of KarXT and KarX-EC in Schizophrenia and Autism-Related Irritability, sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company. Recruiting at 105 sites in 11 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company (part of Bristol-Myers Squibb) · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
3,563 studies on the registry are indexed under Schizophrenia; 491 are open to participants now.
This study's planned enrollment of 400 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.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KarXT
Drug: KarXT · Drug: KarX-EC
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: BMS-986510, Xanomeline/Trospium chloride
Specified dose on specified days
Also known as: BMS-986519, Xanomeline Enteric-coated
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to 56 weeks
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to 56 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 56 weeks
Number or participants with cholinergic symptoms
Time frame: Up to 56 weeks
Number of participants with anticholinergic symptoms
Time frame: Up to 56 weeks
Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 56 weeks
Change from baseline on the Simpson-Angus Scale (SAS)
Time frame: Up to 52 weeks
Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to 52 weeks
Change from baseline on the Barnes-Akathisia Rating Scale (BARS)
Time frame: Up to 52 weeks
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Showing the first 100 of 105 sites across 11 countries. Choose a country and city above to see the rest.
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
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
Karuna Therapeutics, Inc., a Bristol Myers Squibb company →