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A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Evening-dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, on Post-waking, Early Morning Function in Children Aged 6 to 12 With Attention Deficit Hyperactivity Disorder (ADHD)

Trial Profile

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Evening-dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, on Post-waking, Early Morning Function in Children Aged 6 to 12 With Attention Deficit Hyperactivity Disorder (ADHD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jan 2019

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms AHEAD
  • Sponsors Ironshore Pharmaceutical and Development
  • Most Recent Events

    • 10 Jan 2019 According to an Ironshore Pharmaceuticals and Development media release, Post Hoc Analysis of BSFQ and PREMB-R by Norm-Referenced Cut-Offs will be presented at the 2019 Annual American Professional Society of ADHD and Related Disorders (APSARD) Meeting.
    • 09 Aug 2018 According to an Ironshore Pharmaceuticals and Development media release, the U.S. Food and Drug Administration has approved the New Drug Application for JORNAY PM for the treatment of Attention Deficit Hyperactivity Disorder in patients 6 years and older. Ironshore plans to initiate the commercial launch of JORNAY PM in the first half of 2019.
    • 25 Oct 2017 Post hoc analysis from this trial presented in a Cayman Chemical Media Release.
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