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A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System (d-ATS) Compared to Placebo in Children and Adolescents With ADHD

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Crossover, Laboratory Classroom Study to Evaluate the Safety and Efficacy of d-Amphetamine Transdermal Drug Delivery System (d-ATS) Compared to Placebo in Children and Adolescents With ADHD

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 27 Dec 2023

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At a glance

  • Drugs Dexamfetamine (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Therapeutic Use
  • Sponsors Noven Pharmaceuticals

    • Most Recent Events

    • 01 Jun 2023 Secondary endpoint results and Post Hoc Effect Size Analyses from a Pivotal Trial published in the Journal of Child and Adolescent Psychopharmacology
    • 23 Mar 2022 According to a Noven Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has approved XELSTRY (dextroamphetamine) transdermal system, CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) for adults and pediatric patients 6 years and older, this approval enables the company to finalize preparations for commercial launch in the U.S. as early as the second half of this year.
    • 01 Mar 2022 Results assessing efficacy and Safety of Dextroamphetamine Transdermal System for the Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents, published in the Journal of Child and Adolescent Psychopharmacology
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