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A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 91 → 94 locations Interventions modified · Eligibility criteria expanded, about 51 words · Secondary endpoints revised (6) · 1 more Show 4 more changesShow less
    • Interventions modified
    • Eligibility criteria expanded, about 51 words
    • Secondary endpoints revised (6)
    • Study title revised
  2. Trial sites reduced: 95 → 91 locationsv7
  3. Study sites revised (95)v6 See this version in full on ClinicalTrials.gov ↗
  4. Trial sites expanded: 58 → 95 locationsv5
  5. Study sites: 59 to 58v4
  6. Trial sites expanded: 55 → 59 locations Start date changed from estimate of Mar 31, 2026 to Apr 7, 2026v3 Show 1 more changeShow less
    • Start date changed from estimate of Mar 31, 2026 to Apr 7, 2026
  7. Trial status: Not Yet Recruiting to Recruiting Study sites: 56 to 55v2 Show 1 more changeShow less
    • Study sites: 56 to 55
  8. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
Trial Details
NCT Number NCT07424404
Lead Sponsor Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Conditions Schizophrenia, Autism-Related Irritability
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov