A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of Dasotraline in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Trial Profile

A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of Dasotraline in Children Aged 6 to 12 Years With Attention-Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Completed
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2017

At a glance

  • Drugs Dasotraline (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Sunovion Pharmaceuticals
  • Most Recent Events

    • 21 Apr 2017 According to a Sunovion Pharmaceuticals media release, the full study results were presented at the 6th World Congress on ADHD.
    • 21 Apr 2017 Results published in the Sunovion Pharmaceuticals Media Release
    • 12 Apr 2017 According to a Sumitomo Dainippon Pharma media release, based on the results of this study, Sunovion Pharmaceuticals Inc., a U.S. subsidiary of Sumitomo Dainippon Pharma, plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in FY2017 for ADHD in adults and pediatric populations.
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