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Not yet recruiting Phase 3 Interventional

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

ClinicalTrials.gov ID: NCT07284745

Public ClinicalTrials.gov record NCT07284745. 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.

ClinicalTrials.gov public records Last synced Sep 4, 2026, 6:23 PM EDT

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, Tolerability, and Pharmacokinetics of KarXT + KarX-EC in Children and Adolescents (5 to 17 Years of Age) With Irritability Associated With Autism Spectrum Disorder

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Study identification

NCT ID
NCT07284745
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Bristol-Myers Squibb
Industry
Enrollment
176 participants

Conditions and interventions

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 5, 2029
Completion
Aug 5, 2029
Last update posted
Aug 23, 2026

2026 – 2029

United States locations

U.S. sites
29
U.S. states
16
U.S. cities
28
Facility City State ZIP Site status
Local Institution - 0036 Dothan Alabama 36303
Local Institution - 0236 Phoenix Arizona 85006
Local Institution - 0031 Anaheim California 92805
Local Institution - 0257 Glendale California 91203
Local Institution - 0233 Redlands California 92373
Local Institution - 0181 San Rafael California 94903
Local Institution - 0252 Colorado Springs Colorado 80910
Local Institution - 0264 Boca Raton Florida 33428
Local Institution - 0099 Gainesville Florida 32607
Local Institution - 0278 Gainesville Florida 32607
Local Institution - 0155 Peachtree Corners Georgia 30071
Local Institution - 0266 Chicago Illinois 60622
Local Institution - 0242 Louisville Kentucky 40202
Local Institution - 0160 Bloomfield Hills Michigan 48302
Local Institution - 0220 Detroit Michigan 48203
Local Institution - 0110 Las Vegas Nevada 89128
Local Institution - 0246 Staten Island New York 10312
Local Institution - 0263 The Bronx New York 10461
Local Institution - 0122 Cincinnati Ohio 45229
Local Institution - 0247 West Chester Ohio 45069
Local Institution - 0269 Danville Pennsylvania 17821
Local Institution - 0041 Dallas Texas 75243
Local Institution - 0034 Houston Texas 77090
Local Institution - 0273 Plano Texas 75093
Local Institution - 0291 San Antonio Texas 78249
Local Institution - 0185 Spring Texas 77381
Local Institution - 0074 Bountiful Utah 84010
Local Institution - 0271 Provo Utah 84604
Local Institution - 0260 Richmond Virginia 23220

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 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07284745, 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 Aug 23, 2026 · Synced Sep 4, 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 NCT07284745 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →