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NCT07285798 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Not yet
Registry status
Phase 3
Development phase
176
Enrollment target

NCT07285798: Clinical Trial Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT07285798 is a Phase 3 study that has not yet begun recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 176 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07285798, a Phase 3 study, has not yet begun recruiting, sponsored by Bristol-Myers Squibb.

NOT YET RECRUITING
Registry status
Phase 3
Development phase
176 participants
Enrollment target

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.

Interventions

  • DRUG KarXT
  • DRUG KarX-EC
  • DRUG KarXT + KarX-EC Matching Placebo

Trial Details

FieldValue
Enrollment Target 176 participants
Start Date 2026-09-11
Est. Completion 2029-08-04
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What is known before NCT07285798 opens enrollment

NCT07285798 is an interventional study that assigns participants to a tested intervention. The registered 176 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 3 interventions - of which KarXT is the first listed.

NCT07285798 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07285798 about?

NCT07285798 is a clinical study titled "A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder". The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

What is the current status of trial NCT07285798?

This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 176 participants. The study started on 2026-09-11. Estimated completion is 2029-08-04.

What interventions are being tested in trial NCT07285798?

The interventions under investigation include: KarXT (DRUG), KarX-EC (DRUG), KarXT + KarX-EC Matching Placebo (DRUG).

Who is sponsoring clinical trial NCT07285798?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07285798's enrollment target sits among peer trials

176 1438th of 2000 higher than 561 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07285798, the US trial registry maintained by the National Library of Medicine. NCT07285798 (mid enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.