A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Trial Profile

A Randomized, Double Blind, Multicenter, Placebo Controlled, Parallel Group, Efficacy and Safety Study of 2 Doses of Dasotraline in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2017

At a glance

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

    • 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.
    • 13 Jan 2017 According to a Sunovion Pharmaceuticals Media Release, full results of study SEP360-221 and study SEP360-301 are being analyzed and will be presented at upcoming scientific meetings.
    • 13 Jan 2017 Primary endpoint has not been met. (Change from baseline at Week 8 in ADHD symptoms measured by the ADHD Rating Scale Version IV (ADHD RS IV) with adult prompts total score.), as reported in a Sunovion Pharmaceuticals Media Release.
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