NCT05151471

Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 202 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

Conditions

• ALS

Interventions

Type	Name	Description
DRUG	MT-1186	Oral edaravone
DRUG	Placebo	Oral

Timeline

• Start date: 2022-01-11
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2021-12-09
• Last updated: 2025-12-30
• Results posted: 2025-03-27

Locations

37 sites across 6 countries: United States, Canada, Germany, Japan, South Korea, Switzerland

Regulatory

• FDA-regulated drug study