A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)

Trial Profile

A 6-week, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-group Efficacy and Safety Study of Dasotraline Versus Placebo in Subjects 6 to 12 Years of Age With Attention Deficit Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase II/III

Latest Information Update: 07 Jul 2017

At a glance

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

    • 14 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, the full study results will be presented at the 2017 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting.
    • 14 Jan 2017 Results published in the Sunovion Pharmaceuticals Media Release
    • 13 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, based on positive data from this trial and discussions with the U.S. FDA, company intends to submit a New Drug Application (NDA) to the FDA in 2017 for ADHD in children and adults.
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