A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
Part of paid clinical trials in Phoenix, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT07285798
- Phase
- PHASE3
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Irritability Associated With Autism Spectrum Disorder
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- KarXT — DRUGSpecified dose on specified days
- KarX-EC — DRUGSpecified dose on specified days
- KarXT + KarX-EC Matching Placebo — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Key Dates
- Start date
- Sep 11, 2026
- Status verified
- Mar 2026
- Primary completion
- Aug 4, 2029
- Completion
- Aug 4, 2029
Study Design
- Enrollment
- 176 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: KarXT + KarX-EC Arm
- Experimental: Placebo
Primary Outcome Measure
Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8 [ Time Frame: Week 8 ]
Central Contacts
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
- First line of the email MUST contain NCT # and Site #.
Locations (19)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0062 | Phoenix | Arizona | 85006 | Site 0062 |
| Local Institution - 0001 | Bentonville | Arkansas | 72712 | - |
| Local Institution - 0013 | Glendale | California | 91203 | Site 0013 |
| Local Institution - 0117 | Los Angeles | California | 90095 | Site 0117 |
| Local Institution - 0126 | Orange | California | 92868 | Site 0126 |
| Local Institution - 0115 | San Juan Capistrano | California | 92675 | Site 0115 |
| Local Institution - 0116 | San Rafael | California | 94903 | Site 0116 |
| Local Institution - 0080 | Orlando | Florida | 32803 | Site 0080 |
| Local Institution - 0014 | Chicago | Illinois | 60622 | Site 0014 |
| Local Institution - 0006 | Lexington | Kentucky | 40536 | - |
| Local Institution - 0051 | Lexington | Massachusetts | 02421 | Site 0051 |
| Local Institution - 0016 | Columbia | Missouri | 65201 | Site 0016 |
| Local Institution - 0046 | Lincoln | Nebraska | 68526 | Site 0046 |
| Local Institution - 0114 | Neptune City | New Jersey | 07753-4859 | Site 0114 |
| Local Institution - 0038 | Staten Island | New York | 10312 | Site 0038 |
| Local Institution - 0052 | Cincinnati | Ohio | 45229 | Site 0052 |
| Local Institution - 0003 | Pittsburgh | Pennsylvania | 15213 | Site 0003 |
| Local Institution - 0009 | Orem | Utah | 84097 | Site 0009 |
| Local Institution - 0019 | Everett | Washington | 98201 | Site 0019 |
Find similar trials in Phoenix, AZ
Related Studies
- Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric PatientsPHASE3 · Recruiting · Intra-Cellular Therapies, Inc. · Dothan, Alabama
- Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) in Pediatric PatientsPHASE3 · Recruiting · Intra-Cellular Therapies, Inc. · Little Rock, Arkansas
- A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With AutismPHASE3 · Not Yet Recruiting · Bristol-Myers Squibb · Dothan, Alabama