A Phase 3 interventional study of KarXT and KarX-EC in Irritability Associated With Autism Spectrum Disorder, sponsored by Bristol-Myers Squibb. Recruiting at 67 sites in 10 countries. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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Among 773 studies in Autism Spectrum Disorder with a site in United States — 165 open to participants now, 204 under way, 9 of them phase 3. Autism Spectrum Disorder · United States.
Among the 773 studies in Autism Spectrum Disorder with a site in United States, this one is the 87th largest by planned enrollment of the 658 interventional ones that give a count, is one of 47 that started in 2026, is one of 25 in phase 3, reaches primary completion later than 180 of the 202 other live ones, and was the 734th registered.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.
Browse Autism Spectrum Disorder studies →165 of the 773 studies in Autism Spectrum Disorder with a site in United States are open now. Recruiting first, the newest first:
New York State Institute for Basic Research · Sites in United States
Ages 5–12
Massachusetts General Hospital · Sites in United States
Ages 12–17
Schweitzer Engineering Laboratories · Sites in United States
Ages 24 mo–60 mo · Healthy volunteers
Children's Hospital Medical Center, Cincinnati · Sites in United States
Ages 12–18
Bristol-Myers Squibb · Sites in United States, Australia, Canada and 1 more country
Ages 5–17
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 349 Autism Spectrum Disorder studies recruiting now, 48 (14%) set no upper age limit and 294 (84%) stop at 75 or younger; 298 take children under 18; 92 take healthy volunteers.
This study: 5 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
773 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 52 · Phase 2 117 · Phase 3 33 · Phase 4 16
First in 2004; this study’s year is marked. 47 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 176 is above the median of 52 across 1,370 interventional studies indexed under Autism Spectrum Disorder.
Median enrollment 50 across the 658 interventional studies, 132 across the 114 observational. Of the 522 that completed or were terminated, 174 (33%) have results posted.
This tab as a report to print or save as PDF → With an account.
89 of 773 have an industry lead sponsor. The 10 most frequent:
Bristol-Myers Squibb is the lead sponsor of 1,560 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Bristol-Myers Squibb has 2 studies filed under Autism Spectrum Disorder — fewer than ten, so there is no comparison to draw.
67 of the studies in Autism Spectrum Disorder with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06706674Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric Patients | 2027-06-21 |
| NCT06690398Phase 3Intra-Cellular Therapies, Inc.Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients | 2027-06-21 |
| NCT07670000Natalia PoluektovaMental And Speech Developmental Delay Autism Spectrum-Type Behavioral Disorder | 2026-11 |
| NCT04242355Yale UniversityTranscranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder | 2026-12 |
| NCT06059352Loma Linda UniversitySleep and Central Auditory Processing Disorder in Autism Spectrum Disorder | 2026-12 |
Add all 67 to your calendar (.ics) → With an account.
Among the 773 studies in Autism Spectrum Disorder with a site in United States, from their registry updates:
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The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
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.
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.
Drug: KarXT · Drug: KarX-EC
Drug: KarXT + KarX-EC Matching Placebo
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
Specified dose on specified days
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Time frame: Week 8
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Time frame: Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Time frame: Week 8
Number of Participants With ABC-I response at Week 8
ABC-I response is determined by ≥ 25% reduction in ABC-I score from baseline.
Time frame: Week 8
Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8
Time frame: Week 8
Change From Baseline on the Stereotypic Behavior Subscale at Week 8
Time frame: Week 8
Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8
Time frame: Week 8
Change From Baseline on the Inappropriate Speech Subscale at Week 8
Time frame: Week 8
Number of Participants With Procholinergic Symptoms
Time frame: Up to approximately 12 weeks
Number of Participants With Anticholinergic Symptoms
Time frame: Up to approximately 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to approximately 12 weeks
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to approximately 12 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to approximately 12 weeks
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Time frame: Up to approximately 8 weeks
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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 Oct 2026 (actual). Primary completion is estimated for Aug 2029, 34 months after the start.
Of 18 phase 3 interventional studies under Autism Spectrum Disorder, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 38. This study's planned 34 months is close to that.
Start moved twice since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2026, last on Nov 10, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
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