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A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder

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Trial Profile

A Phase 3, Open-label, Multicenter, 12-Month Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years Diagnosed With Attention-deficit / Hyperactivity Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2022

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At a glance

  • Drugs Lisdexamfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Shire; Takeda

    • Most Recent Events

    • 01 Mar 2022 Results assessing safety and tolerability of lisdexamfetamine dimesylate (LDX) in preschool-aged children published in the Journal of Child and Adolescent Psychopharmacology
    • 10 Feb 2021 Number of treatment arms is decreased from 2 to 1, removing the separate arm for directly enrolled participants and the experimental arm of Roll-over Participants is re-labelled as Experimental: SPD489 arm. Study design is changed from parallel to single group assignment.
    • 29 May 2020 Status changed from active, no longer recruiting to completed.

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