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Efficacy and Safety Study of Oral Edaravone Administered to Subjects with ALS

The purpose of this trial is to evaluate and compare the efficacy, safety, tolerability, and changes in nerve conduction tests of 2 different dosing regimens of oral edaravone (study drug) in participants with ALS. The 2 dosing groups are as follows: Group 1) Oral edaravone at a dose 105mg once daily; Group 2) Oral edaravone dosing comparable to an IV edaravone dosing schedule (dose of 105mg once daily for 14 days followed by placebo once daily for 14 days, and subsequently, repeat oral edaravone at a dose of 105mg once daily for 10 days followed by placebo once daily for 18 days). Dosing will occur over a 48 week period, after an 8 week screening period. Eligible participants will be randomized 1:1 to each dosing group (50% chance of being randomized to either group).

Principal Investigators: Shafeeq Ladha, MD

Enrollment Contact:
Jessie Duncan

Open and enrolling subjects.
Phoenix, Arizona
Primary Sponsor
Mitsubishi Tanabe Pharma Development, Inc.