A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy Laboratory Classroom Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder

Trial Profile

A Multicenter, Dose-Optimized, Double-Blind, Randomized, Placebo-Controlled, Parallel Efficacy Laboratory Classroom Study With KP415 in Children With Attention-Deficit/Hyperactivity Disorder

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2018

At a glance

  • Drugs KP-415 (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors KemPharm
  • Most Recent Events

    • 09 Jul 2018 According to a KemPharm media release, the company is planning to submit New Drug Application for KP415 with the FDA in the first quarter of 2019, based on the data from this and other trials.
    • 09 Jul 2018 Primary endpoint has been met. (Change in SKAMP-C Scores), as reported in a KemPharm Media Release.
    • 09 Jul 2018 Results published in the KemPharm Media Release
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