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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 Oct 20, 2026, 12:18 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 11, 2026 (Estimated)
Primary completion
Aug 6, 2029 (Estimated)
Completion
Aug 6, 2029 (Estimated)
Last update posted
Aug 24, 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 24, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07284745 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →