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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adult ADHD Patients

Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm, Multi-Center Study Measuring the Efficacy and Safety of PRC-063 in Adult ADHD Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 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 Feb 2018 According to a Purdue Pharma media release, Health canada approved FOQUEST (methylphenidate HCl controlled-release capsules) for the treatment of ADHD in adults based on results from this study. FOQUEST is commercially available in Canada. This announcement follows the December 6, 2017 Health Canada Notice of Compliance for FOQUEST.
    • 01 Feb 2018 Results presented in a Purdue Pharma media release.
    • 01 Feb 2018 Primary endpoint (Change from Baseline in Clinician-administered ADHD-5-Rating Scale) has been met.
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