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A Randomized, Double-blind Study of the Time Course of Response of PRC-063 in Adults With ADHD in a Simulated Adult Workplace Environment

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Trial Profile

A Randomized, Double-blind Study of the Time Course of Response of PRC-063 in Adults With ADHD in a Simulated Adult Workplace Environment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2019

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At a glance

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

    • Most Recent Events

    • 01 Mar 2019 According to an Adlon Therapeutics media release, the U.S. Food and Drug Administration (FDA) approved Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients six years and older. The FDA approval of Adhansia XR was based on four clinical studies evaluating the efficacy and safety of Adhansia XR in patients who met DSM-5 criteria for ADHD.
    • 08 Jul 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 27 Aug 2014 New trial record
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