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

StatusNot Yet Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 63 → 67 locations Start date: Sep 11, 2026 to Oct 2, 2026 · Eligibility criteria expanded, about 7 words · Secondary endpoints: details revised at 1 of 13 entries Show 3 more changesShow less
    • Start date: Sep 11, 2026 to Oct 2, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 13 entries
  2. Minor Trial sites expanded: 54 → 63 locations Primary and study completion dates: Aug 4, 2029 to Aug 6, 2029v6 Show 1 more changeShow less
    • Primary and study completion dates: Aug 4, 2029 to Aug 6, 2029
  3. Minor Study sites: 55 to 54 Secondary endpoints: details revised at 5 of 13 entries · Eligibility criteria shortened, about 2 wordsv5 Show 2 more changesShow less
    • Secondary endpoints: details revised at 5 of 13 entries
    • Eligibility criteria shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Notable Start date: Feb 27, 2026 to Sep 11, 2026 Study sites: 54 to 55v4 Show 1 more changeShow less
    • Study sites: 54 to 55
  5. Minor Study sites: 53 to 54v3
  6. Minor Study sites: 51 to 53v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.
Trial Details
NCT Number NCT07285798
Lead Sponsor Bristol-Myers Squibb
Conditions Irritability Associated With Autism Spectrum Disorder
Enrollment 176 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov