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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 Spectrum Disorder

ClinicalTrials.gov ID: NCT07285798

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.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:57 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, and Tolerability 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
NCT07285798
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
Oct 2, 2026 (Estimated)
Primary completion
Aug 6, 2029 (Estimated)
Completion
Aug 6, 2029 (Estimated)
Last update posted
Sep 28, 2026

2026 – 2029

United States locations

U.S. sites
23
U.S. states
16
U.S. cities
22
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 - 0132 San Diego California 92102 —
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 - 0072 Decatur Georgia 30030 —
Local Institution - 0014 Chicago Illinois 60622 —
Local Institution - 0026 Chicago Illinois 60622 —
Local Institution - 0051 Lexington Massachusetts 02421 —
Local Institution - 0016 Columbia Missouri 65201 —
Local Institution - 0036 Saint Charles Missouri 63304 —
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 44 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 Sep 28, 2026 · Synced Oct 21, 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 public registry record, listed eligibility criteria, and available contact information for NCT07285798 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →