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NCT07284745

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

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened Show 4 more changesShow less
    • Eligibility criteria expanded, about 7 words
    • Study sites: 39 to 41
    • Start date changed from estimate of Sep 11, 2026 to Oct 6, 2026
    • Secondary endpoints: details revised at 2 of 14 entries
  2. Trial sites expanded: 35 → 39 locationsv8
  3. Primary and study completion pushed from Jul 5, 2029 to Aug 6, 2029
    • Trial sites reduced: 40 → 35 locations
    v7
  4. Eligibility criteria shortened, about 3 words
    • Trial sites reduced: 45 → 40 locations
    • Secondary endpoints: 13 to 14
    v6
  5. Start date: Feb 27, 2026 to Sep 11, 2026
    • Site details revised at 1 of 45 sites
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Site contacts updated at 1 of 45 sitesv4
  2. Primary and study completion dates: Jul 5, 2026 to Jul 5, 2029
    • Site details revised at 1 of 45 sites
    v3
  3. Study sites: 44 to 45v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Change From Baseline in the Aberrant Behavior Checklist Irritability (ABC-I) Score at Week 8
Timeframe: Week 8

Secondary (14)

Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Week 8
Clinical Global Impression-Improvement (CGI-I) Score at Week 8
Number of Participants With ABC-I Response at Week 8
Change From Baseline on the ABC Subscale for Social Withdrawal at Week 8
Change From Baseline on the Stereotypic Behavior Subscale at Week 8
Show 9 moreShow less
Change From Baseline on the Hyperactivity/Noncompliance Subscale at Week 8
Change From Baseline on the Inappropriate Speech Subscale at Week 8
Number of Participants With Procholinergic Symptoms
Number of Participants With Anticholinergic Symptoms
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants With Adverse Events of Special Interest (AESIs)
Number of Participants With AEs Leading to Discontinuation of Study Intervention
Plasma concentrations of KarXT

Arms and interventions

KarXT + KarX-EC ArmExperimental
PlaceboPlacebo comparator

Drugs: KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo

Sites

41 sites in 4 countries

United States 31, Canada 5, Australia 4, Puerto Rico 1