Irritability Associated With Autism Spectrum DisorderPhase 3NCT07284745
A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism
A Phase 3 study testing KarXT and KarX-EC in people with Irritability Associated With Autism Spectrum Disorder, run by Bristol-Myers Squibb at 39 sites in 4 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
- 39 sitesin 4 countries
- Study dates
- 11 Sep 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 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
39 sites in 4 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
39 sites in 4 countries
United States29 sites
Local Institution - 0031
Anaheim, California, 92805
Site 0031
Local Institution - 0160
Bloomfield Hills, Michigan, 48302
Site 0160
Local Institution - 0264
Boca Raton, Florida, 33428
Site 0264
Local Institution - 0074
Bountiful, Utah, 84010
Local Institution - 0266
Chicago, Illinois, 60622
Site 0266
Local Institution - 0122
Cincinnati, Ohio, 45229
Site 0122
Local Institution - 0252
Colorado Springs, Colorado, 80910
Local Institution - 0041
Dallas, Texas, 75243
Site 0041
Local Institution - 0269
Danville, Pennsylvania, 17821
Site 0269
Local Institution - 0220
Detroit, Michigan, 48203
Local Institution - 0036
Dothan, Alabama, 36303
Site 0036
Local Institution - 0099
Gainesville, Florida, 32607
Site 0099
Local Institution - 0278
Gainesville, Florida, 32607
Site 0278
Local Institution - 0257
Glendale, California, 91203
Site 0257
Local Institution - 0034
Houston, Texas, 77090
Site 0034
Local Institution - 0110
Las Vegas, Nevada, 89128
Site 0110
Local Institution - 0242
Louisville, Kentucky, 40202
Site 0242
Local Institution - 0155
Peachtree Corners, Georgia, 30071
Site 0155
Local Institution - 0236
Phoenix, Arizona, 85006
Site 0236
Local Institution - 0273
Plano, Texas, 75093
Site 0273
Local Institution - 0271
Provo, Utah, 84604
Local Institution - 0233
Redlands, California, 92373
Site 0233
Local Institution - 0260
Richmond, Virginia, 23220
Site 0260
Local Institution - 0291
San Antonio, Texas, 78249
Site 0291
Local Institution - 0181
San Rafael, California, 94903
Site 0181
Local Institution - 0185
Spring, Texas, 77381
Site 0185
Local Institution - 0246
Staten Island, New York, 10312
Site 0246
Local Institution - 0263
The Bronx, New York, 10461
Site 0263
Local Institution - 0247
West Chester, Ohio, 45069
Canada5 sites
Local Institution - 0289
Airdrie, Alberta, T4A 0K9
Site 0289
Local Institution - 0136
Edmonton, Alberta, T6G 1Z1
Site 0136
Local Institution - 0135
Kingston, Ontario, K7L4X3
Site 0135
Local Institution - 0187
Montreal, Quebec, H3T 1C5
Site 0187
Local Institution - 0205
Toronto, Ontario, M4G 1R8
Site 0205
Australia4 sites
Local Institution - 0007
Brisbane, Queensland, 4101
Site 0007
Local Institution - 0045
Melbourne, Victoria, 3052
Site 0045
Local Institution - 0286
Melbourne, Victoria, 3168
Site 0286
Local Institution - 0010
Westmead, New South Wales, 2145
Site 0010
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics 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
- Cobenfy, 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 | Placebo comparator | 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 (14)
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
Plasma concentrations of KarXT
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 start11 Sep 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
- NCT07284745
- Sponsor's protocol ID
- CN012-0044
- Other IDs
- 2025-523189-26-00, U1111-1325-4950, 2025
- Status last verified
- Aug 2026
- First submitted
- 9 Dec 2025
- Last updated
- 24 Aug 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 24 Aug 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, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07284745
- Acronym / sponsor ID
- CN012-0044
- Keywords
- Cobenfy, 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
- 11 Sep 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 | Placebo comparator | 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 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
14 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
Plasma concentrations of KarXT
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 24 Aug 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
39 sites in 4 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 39 sites in 4 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 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Canada, Australia, Puerto Rico. 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?
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 24 Aug 2026.