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A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

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Trial Profile

A Phase 3, Multi-center, Open-label, Safety Study of Oral Edaravone Administered over 48 Weeks in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2024

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At a glance

  • Drugs Edaravone (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Adverse reactions; Registrational
  • Sponsors Mitsubishi Tanabe Pharma America

Most Recent Events

  • 17 Sep 2024 According to a Mitsubishi Tanabe Pharma America media release,findings from an updated analysis evaluating treatment patterns and clinical outcomes in RADICAVA(edaravone)-treated individuals, along with the extension study of the Phase 3 trial (MT-1186-A01) that supported the U.S. approval of RADICAVA ORS and the study to investigate the superiority of daily dosing vs. the FDA-approved on/off regimen of RADICAVA ORS in individuals living with ALS
  • 05 Jun 2024 According to a Mitsubishi Tanabe Pharma America media release, data from this trial to be included in a presentation at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 Annual Meeting being held in Stockholm, Sweden from June 17-20, 2024.
  • 08 Mar 2024 This trial has been completed Italy in according to European Clinical Trials Database record.

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