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A Phase 3, Multicenter, Open-label Treatment-optimized, Double-blind, Randomized, Placebo-controlled, Forced-withdrawal, Parallel Group Study to Evaluate the Safety and Efficacy of Evening Dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

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Trial Profile

A Phase 3, Multicenter, Open-label Treatment-optimized, Double-blind, Randomized, Placebo-controlled, Forced-withdrawal, Parallel Group Study to Evaluate the Safety and Efficacy of Evening Dosed HLD200, a Novel Delayed and Extended Release Formulation (DELEXIS) of Methylphenidate Hydrochloride, in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Oct 2023

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At a glance

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

    • Most Recent Events

    • 26 Sep 2023 Results comparing data from this study and real world study, to derive possible learnings on how to approach adverse events (AEs) that emerge during dose titration, published in the Clinical Therapeutics
    • 22 Jun 2021 Results of post hoc analysis (n=117) assessing symptom and functional impairment scores by applying categorical cutoffs for response and remission in the context of DR/ER-MPH dosing during the 6-week, open-label, treatment-optimization period and rates of treatment-emergent adverse events in the context of DR/ER-MPH dosing, published in the Journal of Clinical Psychiatry.
    • 06 Nov 2020 Results of post-hoc analysis published in the Clinical Therapeutics
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