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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD

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Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Adult Laboratory Classroom Study to Evaluate the Safety and Efficacy of PRC-063 Compared to Placebo in Adults With ADHD

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Jul 2021

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At a glance

  • Drugs Methylphenidate (Primary)
  • Indications Attention-deficit hyperactivity disorder
  • Focus Therapeutic Use
  • Sponsors Purdue Pharma

Most Recent Events

  • 01 Jul 2021 Results published in an Adlon Therapeutics L.P Media Release.
  • 01 Jul 2021 Primary endpoint (Change in PERMP-T (Permanent Measure of Productivity (Total Score)).) has been met, according to a Adlon Therapeutics L.P media release.
  • 01 Jul 2021 According to an Adlon Therapeutics L.P media release, the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the prescribing information for Adhansia XR (methylphenidate hydrochloride) extended-release capsules CII, based on data from this trial.

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