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A Randomized, Phase 3, Double-Blind, Crossover Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD

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Trial Profile

A Randomized, Phase 3, Double-Blind, Crossover Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Mar 2019

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At a glance

  • Drugs Methylphenidate (Primary) ; Lisdexamfetamine
  • 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.
  • 17 Jan 2017 Status changed from recruiting to completed.
  • 18 Feb 2016 Planned End Date changed from 1 Feb 2016 to 1 Feb 2017, according to ClinicalTrials.gov record.

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