Irritability Associated With Autism Spectrum DisorderPhase 3NCT07285798
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
A Phase 3 study testing KarXT and KarX-EC in people with Irritability Associated With Autism Spectrum Disorder, run by Bristol-Myers Squibb at 67 sites in 10 countries.
Trial summary
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Irritability Associated With Autism Spectrum Disorder
- What is being tested?
- KarXT and KarX-EC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 67 sitesin 10 countries
- Study dates
- 2 Oct 2026to 6 Aug 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
- Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).
Who cannot join
- Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
- Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
- Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
- Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
67 sites in 10 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
67 sites in 10 countries
United States23 sites
Local Institution - 0014
Chicago, Illinois, 60622
Site 0014
Local Institution - 0026
Chicago, Illinois, 60622
Local Institution - 0052
Cincinnati, Ohio, 45229
Site 0052
Local Institution - 0016
Columbia, Missouri, 65201
Site 0016
Local Institution - 0072
Decatur, Georgia, 30030
Site 0072
Local Institution - 0019
Everett, Washington, 98201
Site 0019
Local Institution - 0013
Glendale, California, 91203
Site 0013
Local Institution - 0051
Lexington, Massachusetts, 02421
Site 0051
Local Institution - 0046
Lincoln, Nebraska, 68526
Site 0046
Local Institution - 0117
Los Angeles, California, 90095
Site 0117
Local Institution - 0114
Neptune City, New Jersey, 07753-4859
Site 0114
Local Institution - 0130
New Haven, Connecticut, 06519
Site 0130
Local Institution - 0126
Orange, California, 92868
Site 0126
Local Institution - 0009
Orem, Utah, 84097
Site 0009
Local Institution - 0080
Orlando, Florida, 32803
Site 0080
Local Institution - 0062
Phoenix, Arizona, 85006
Site 0062
Local Institution - 0003
Pittsburgh, Pennsylvania, 15213
Site 0003
Local Institution - 0036
Saint Charles, Missouri, 63304
Site 0036
Local Institution - 0132
San Diego, California, 92102
Site 0132
Local Institution - 0115
San Juan Capistrano, California, 92675
Site 0115
Local Institution - 0116
San Rafael, California, 94903
Site 0116
Local Institution - 0125
Spring, Texas, 77381
Site 0125
Local Institution - 0038
Staten Island, New York, 10312
Site 0038
Poland10 sites
Local Institution - 0106
Gdansk, Pomeranian Voivodeship, 80-542
Site 0106
Local Institution - 0104
Katowice, 40-146
Local Institution - 0109
Lublin, 20-059
Local Institution - 0134
Lublin, 20-701
Site 0134
Local Institution - 0108
Poznan, Greater Poland Voivodeship, 60-744
Site 0108
Local Institution - 0113
Szczecin, West Pomeranian Voivodeship, 70-419
Local Institution - 0129
Szczecin, West Pomeranian Voivodeship, 70-419
Site 0129
Local Institution - 0107
Warsaw, Masovian Voivodeship, 02-957
Local Institution - 0105
Wroclaw, Lower Silesian Voivodeship, 54-234
Local Institution - 0133
Zabrze, 41-807
Site 0133
India9 sites
Local Institution - 0100
Belgavi, Karnataka, 590001
Local Institution - 0138
Kanpur, Uttar Pradesh, 208002
Site 0138
Local Institution - 0097
Kolkata, West Bengal, 700020
Local Institution - 0096
Kozhikode, Kerala, 673009
Site 0096
Local Institution - 0099
Nagpur, 440010
Site 0099
Local Institution - 0136
Nashik, Maharashtra, 422005
Site 0136
Local Institution - 0137
New Delhi, 110075
Site 0137
Local Institution - 0139
Pune, Maharashtra, 411011
Site 0139
Local Institution - 0101
Sakri, Maharashtra, 441108
Site 0101
Romania7 sites
Local Institution - 0118
Bucharest, Bucharest, 030167
Site 0118
Local Institution - 0120
Bucharest, Bucharest, 041914
Site 0120
Local Institution - 0124
Bucharest, 031871
Site 0124
Local Institution - 0123
Cluj-Napoca, 0
Site 0123
Local Institution - 0121
Iași, 700282
Site 0121
Local Institution - 0119
Sibiu, 550082
Site 0119
Local Institution - 0122
Timișoara, 300329
Site 0122
Japan5 sites
Local Institution - 0090
Hirakata, Osaka, 573-0022
Site 0090
Local Institution - 0094
Miyakonojō, Miyazaki, 885-0093
Site 0094
Local Institution - 0091
Ōta-ku, Tokyo, 146-0095
Site 0091
Local Institution - 0093
Yokohama, Kanagawa, 213-8507
Site 0093
Local Institution - 0095
Yoshinogari-cho, Kanzaki-gun, Saga-ken, 842-0192
Site 0095
Hungary4 sites
Local Institution - 0111
Budapest, 1021
Local Institution - 0127
Budapest, 1143
Site 0127
Local Institution - 0112
Siófok, 8600
Local Institution - 0110
Szeged, 6720
Site 0110
Spain4 sites
Local Institution - 0085
Barcelona, Barcelona [Barcelona], 08035
Site 0085
Local Institution - 0087
Barcelona, Catalunya [Cataluña], 08036
Site 0087
Local Institution - 0084
Madrid, 28007
Site 0084
Local Institution - 0086
Madrid, 28031
Site 0086
France3 sites
Local Institution - 0088
Bordeaux, 33076
Local Institution - 0102
Bron, 69678
Site 0102
Local Institution - 0089
Paris, 75019
Site 0089
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
- Being tested
- KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo
- Keywords
- Autism Spectrum Disorder
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called BMS-986510, Xanomeline/Trospium Chloride
Specified dose on specified days
KarX-ECDrug
Also called BMS-986519, Xanomeline Enteric-coated
Specified dose on specified days
KarXT + KarX-EC Matching PlaceboDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT + KarX-EC Arm | Experimental | Not described Receives: Drug: KarXT; Drug: KarX-EC |
| Placebo | Experimental | Not described Receives: Drug: KarXT + KarX-EC Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Measured: Week 8
Secondary outcomes (13)
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Measured: 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.
Measured: Week 8
Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8
Measured: Week 8
Change From Baseline on the Stereotypic Behavior Subscale at Week 8
Measured: Week 8
Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8
Measured: Week 8
Change From Baseline on the Inappropriate Speech Subscale at Week 8
Measured: Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Measured: Week 8
Number of Participants With Procholinergic Symptoms
Measured: Up to approximately 12 weeks
Number of Participants With Anticholinergic Symptoms
Measured: Up to approximately 12 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Up to approximately 12 weeks
Number of Participants With Serious Adverse Events (SAEs)
Measured: Up to approximately 12 weeks
Number of Participants With Adverse Events of Special Interest (AESIs)
Measured: Up to approximately 12 weeks
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Measured: Up to approximately 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start2 Oct 2026 (estimated)
- Primary completion6 Aug 2029 (estimated)
- Study completion6 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritability Associated With Autism Spectrum DisorderStudies 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
- 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
- 176 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
- NCT07285798
- Sponsor's protocol ID
- CN012-0045
- Other IDs
- 2025-523188-39-00, U1111-1325-5048, 2025
- Status last verified
- Sep 2026
- First submitted
- 10 Dec 2025
- Last updated
- 28 Sep 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 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07285798
- Acronym / sponsor ID
- CN012-0045
- Keywords
- Autism Spectrum Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2026 (estimated)
- Primary completion
- 6 Aug 2029 (estimated)
- Study completion
- 6 Aug 2029 (estimated)
- First posted
- 16 Dec 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 assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
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 + KarX-EC Arm | Experimental | Drug: KarXT, Drug: KarX-EC |
| Placebo | Experimental | Drug: KarXT + KarX-EC Matching Placebo |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
- Participants must have an ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).
Key exclusion criteria (5 listed)
- Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
- Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
- Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
- Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
- Other protocol-defined Inclusion/Exclusion criteria may apply.
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 |
|---|---|---|
| KarXTAlso: BMS-986510, Xanomeline/Trospium ChlorideSpecified dose on specified days | Drug | KarXT + KarX-EC Arm |
| KarX-ECAlso: BMS-986519, Xanomeline Enteric-coatedSpecified dose on specified days | Drug | KarXT + KarX-EC Arm |
| KarXT + KarX-EC Matching PlaceboSpecified dose on specified days | Drug | Placebo |
Primary outcome
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Time frame: Week 8
13 secondary outcomes
Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Time frame: Week 8
Number of Participants With ABC-I response at Week 8
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
Clinical Global Impression-Improvement (CGI-I) Score 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
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 28 Sep 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
67 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KarXT and KarX-EC in people with Irritability Associated With Autism Spectrum Disorder, run by Bristol-Myers Squibb at 67 sites in 10 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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 28 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 67 sites in United States, Poland, India, Romania, Japan and 5 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. 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?
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 (time frame: Week 8). 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 28 Sep 2026.