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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 Adolescent 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 Adolescent ADHD Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 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

    • 12 Mar 2019 Results published in the Purdue Pharma Media Release
    • 12 Mar 2019 According to a Purdue Pharma media release, based on positive results from two pivotal trials (see profile 700305396 and 700244756) the Health Canada has issued a Notice of Compliance (NOC) for an expanded indication for FOQUEST (methylphenidate HCl controlled-release capsules), for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents six years of age and older.
    • 12 Mar 2019 Primary endpoint has been met. (Change from Baseline in Clinician-administered ADHD-5-Rating Scale), as reported in a Purdue Pharma media release
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