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A Pharmacokinetics study of RADICAVA (edaravone) for treatment of amyotrophic lateral sclerosis (ALS) in patients with severe hepatic impairment

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Trial Profile

A Pharmacokinetics study of RADICAVA (edaravone) for treatment of amyotrophic lateral sclerosis (ALS) in patients with severe hepatic impairment

Status: Planning
Phase of Trial: Phase IV

Latest Information Update: 24 Aug 2018

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At a glance

  • Drugs Edaravone (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Pharmacokinetics
  • Sponsors Mitsubishi Tanabe Pharma America

    • Most Recent Events

    • 24 Aug 2018 New trial record
    • 08 Aug 2018 According to a Mitsubishi Tanabe Pharma America media release, the company is working with the US FDA to conduct a post-marketing commitment study to understand of the effect of more frequent and higher doses of RADICAVA on ALS. This post-marketing commitment study includes 1) Pharmacokinetics study in patients with severe hepatic impairment (298980) 2) QT/QTc evaluation in healthy subjects (299043). 3)Clinical study with more frequent and higher doses of RADICAVA for at least 24 weeks (299046).

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