NCT04569084

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

A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 384 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 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 change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:

Conditions

• ALS

Interventions

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

Timeline

• Start date: 2020-11-13
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2020-09-29
• Last updated: 2025-12-30
• Results posted: 2025-03-27

Locations

95 sites across 7 countries: United States, Canada, Germany, Italy, Japan, South Korea, Switzerland

Regulatory

• FDA-regulated drug study