An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner.

Trial Profile

An Exploratory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (Severity Classification III) in Double-Blind, Parallel-Group, Placebo-Controlled Manner.

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Aug 2016

At a glance

  • Drugs Edaravone (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Therapeutic Use
  • Sponsors Mitsubishi Tanabe Pharma Corporation
  • Most Recent Events

    • 30 Aug 2016 According to a Mitsubishi Tanabe Pharma media release, the US FDA accepted the NDA for edaravone (MCI-186), an intravenous treatment for ALS. The decision on the NDA expected in June 2017 based on the PDUFA.
    • 21 Apr 2016 Primary endpoint has not been met. (Revised ALS functional rating scale (ALSFRS-R) scores), as per results presented at the 68th Annual Meeting of the American Academy of Neurology.
    • 21 Apr 2016 Results presented at the 68th Annual Meeting of the American Academy of Neurology
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