A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively
Public ClinicalTrials.gov record NCT07424404. 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, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 Years of Age) With Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder
Study identification
- NCT ID
- NCT07424404
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Industry
- Enrollment
- 400 participants
Conditions and interventions
Conditions
Interventions
- KarXT 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
- Apr 6, 2026
- Primary completion
- Mar 7, 2030
- Completion
- Mar 7, 2030
- Last update posted
- May 10, 2026
2026 – 2030
United States locations
- U.S. sites
- 19
- U.S. states
- 11
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Local Institution - 0077 | Anaheim | California | 92805 | Not yet recruiting |
| Local Institution - 0058 | Chino | California | 91710 | Not yet recruiting |
| Local Institution - 0024 | Culver City | California | 90230 | Not yet recruiting |
| Local Institution - 0083 | Redlands | California | 92373 | Not yet recruiting |
| Local Institution - 0089 | San Francisco | California | 94158 | Not yet recruiting |
| Apg Research, Llc | Orlando | Florida | 32803 | Recruiting |
| Atlanta Center for Medical Research | Atlanta | Georgia | 30331 | Recruiting |
| Salveo Integrative Health - Lawrenceville | Lawrenceville | Georgia | 30046 | Recruiting |
| Local Institution - 0039 | Stone Mountain | Georgia | 30083 | Not yet recruiting |
| EmVenio Research Center - Prime Healthcare | Chicago | Illinois | 60622 | Recruiting |
| Local Institution - 0076 | Boston | Massachusetts | 02115 | Not yet recruiting |
| Local Institution - 0059 | Worcester | Massachusetts | 01608 | Not yet recruiting |
| Local Institution - 0061 | Great Neck | New York | 11021 | Not yet recruiting |
| University of Cincinnati Cancer Institute | Cincinnati | Ohio | 45219 | Recruiting |
| Local Institution - 0097 | Philadelphia | Pennsylvania | 19139 | Not yet recruiting |
| Local Institution - 0137 | Nashville | Tennessee | 37212 | Not yet recruiting |
| Local Institution - 0046 | Garland | Texas | 75043 | Not yet recruiting |
| Local Institution - 0066 | Spring | Texas | 77381 | Not yet recruiting |
| Local Institution - 0050 | Richmond | Virginia | 23284 | Not yet recruiting |
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 40 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07424404, 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 May 10, 2026 · Synced May 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07424404 live on ClinicalTrials.gov.