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: 10 Nov 2017

At a glance

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

    • 10 Nov 2017 According to a Sunovion Pharmaceuticals Media Release, U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for dasotraline for the treatment of attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults, based on the data from multiple placebo-controlled safety and efficacy studies, as well as two long-term studies
    • 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
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