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A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Trial Profile

A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2026

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At a glance

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

Most Recent Events

  • 31 Oct 2025 According to a Tanabe Pharma Corporation media release, Mitsubishi Tanabe Pharma Corporation is now called Tanabe Pharma Corporation.
  • 31 Oct 2025 According to Tanabe Pharma Corporation, Mitsubishi Tanabe Pharma America is now called Tanabe Pharma America
  • 03 Apr 2025 According to a Mitsubishi Tanabe Pharma Corporation Media Release, company announced that data from this trial will be shared at the American Academy of Neurology (AAN) 2025 Annual Meeting, taking place April 5-9 in San Diego, CA, and online.

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