An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3) [EXTENSION OF PROFILE 700020947].
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
- 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 Results (N=181) presented at the 68th Annual Meeting of the American Academy of Neurology.
- 05 Mar 2013 New trial record
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History