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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)

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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)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Aug 2023

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At a glance

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

    • Most Recent Events

    • 12 Mar 2021 Results published in the International Clinical Psychopharmacology
    • 13 May 2020 According to a Sunovion Pharmaceuticals Media Release, company has withdrawn the New Drug Applications (NDAs) for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor (DNRI), for the treatment of moderate-to-severe binge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).
    • 09 May 2018 Results (n=973) of pooled post-hoc analysis from two double blind studies (NCT01692782 and NCT02276209) presented at the 171st Annual Meeting of the American Psychiatric Association

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