A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder
Public ClinicalTrials.gov record NCT07285798. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Study identification
- NCT ID
- NCT07285798
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bristol-Myers Squibb
- Industry
- Enrollment
- 176 participants
Conditions and interventions
Interventions
- KarXT Drug
- KarX-EC Drug
- KarXT + KarX-EC Matching Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 5 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 10, 2026
- Primary completion
- Aug 3, 2029
- Completion
- Aug 3, 2029
- Last update posted
- Jun 29, 2026
2026 – 2029
United States locations
- U.S. sites
- 19
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0062 | Phoenix | Arizona | 85006 | — |
| Local Institution - 0013 | Glendale | California | 91203 | — |
| Local Institution - 0117 | Los Angeles | California | 90095 | — |
| Local Institution - 0126 | Orange | California | 92868 | — |
| Local Institution - 0115 | San Juan Capistrano | California | 92675 | — |
| Local Institution - 0116 | San Rafael | California | 94903 | — |
| Local Institution - 0130 | New Haven | Connecticut | 06519 | — |
| Local Institution - 0080 | Orlando | Florida | 32803 | — |
| Local Institution - 0014 | Chicago | Illinois | 60622 | — |
| Local Institution - 0051 | Lexington | Massachusetts | 02421 | — |
| Local Institution - 0016 | Columbia | Missouri | 65201 | — |
| Local Institution - 0046 | Lincoln | Nebraska | 68526 | — |
| Local Institution - 0114 | Neptune City | New Jersey | 07753-4859 | — |
| Local Institution - 0038 | Staten Island | New York | 10312 | — |
| Local Institution - 0052 | Cincinnati | Ohio | 45229 | — |
| Local Institution - 0003 | Pittsburgh | Pennsylvania | 15213 | — |
| Local Institution - 0125 | Spring | Texas | 77381 | — |
| Local Institution - 0009 | Orem | Utah | 84097 | — |
| Local Institution - 0019 | Everett | Washington | 98201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 35 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07285798, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2026 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07285798 live on ClinicalTrials.gov.