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An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder

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Trial Profile

An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumateperone in Pediatric Patients, Ages 5 to Less Than 13 Years, Diagnosed With Autism Spectrum Disorder

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Jul 2026

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Autism spectrum disorder
  • Focus Adverse reactions
  • Acronyms ITI-007-035
  • Sponsors Intra-Cellular Therapies

Most Recent Events

  • 24 Jul 2026 Status changed from recruiting to completed.
  • 21 Aug 2024 New trial record

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