A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.

Trial Profile

A Confirmatory Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-blind, Parallel-group, Placebo-controlled Manner.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 May 2017

At a glance

  • Drugs Edaravone (Primary)
  • Indications Amyotrophic lateral sclerosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Mitsubishi 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.
    • 16 Nov 2008 Status changed from active, no longer recruiting to completed, as reported by clinicaltrials.gov.
    • 16 Nov 2008 Actual end date was Nov 2008, according to clinicaltrials.gov.
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