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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)

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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)

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 11 Aug 2023

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At a glance

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

Most Recent Events

  • 13 May 2020 According to a Sunovion Pharmaceuticals Media Release, company has withdrawn the New Drug Applications (NDAs) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of moderate-to-severe binge eating disorder (BED) and attention deficit hyperactivity disorder (ADHD).
  • 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
  • 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.

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