Trial Profile
An Expanded Controlled Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis in Double-Blind, Parallel-Group, Placebo-Controlled Manner (Phase 3)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 10 Apr 2023
Price :
$35
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At a glance
- Drugs Edaravone (Primary)
- Indications Amyotrophic lateral sclerosis
- Focus Therapeutic Use
- Sponsors Mitsubishi Tanabe Pharma Corporation
- 01 Nov 2022 Results of post hoc analysis from MCI186-16, MCI186-17, and MCI186-19 examining the relationship between urate levels at baseline and functional change measured by the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised total score after edaravone treatment,published in the Muscle and Nerve
- 01 Nov 2022 Results of Post hoc analysis of studies( MCI186-16, MCI186-17, and MCI186-19)Associations between urate levels and amyotrophic lateral sclerosis functional score with edaravone treatment published in the Muscle and Nerve
- 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.