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

NCT07285798 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2026-04-02

No results posted yet for this study

Summary

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

Conditions

  • Irritability Associated With Autism Spectrum Disorder

Interventions

DRUG

KarXT

Specified dose on specified days

DRUG

KarX-EC

Specified dose on specified days

DRUG

KarXT + KarX-EC Matching Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-11
Primary Completion
2029-08-04
Completion
2029-08-04
FDA Drug
Yes

Countries

  • United States
  • France
  • Germany
  • Hungary
  • India
  • Japan
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07285798 on ClinicalTrials.gov