NCT04165824

Safety Study of Oral Edaravone Administered in Subjects With ALS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: Tanabe Pharma America, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Conditions

• ALS

Interventions

Type	Name	Description
DRUG	MT-1186	* An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period * Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.

Timeline

• Start date: 2019-11-18
• Primary completion: 2021-10-07
• Completion: 2021-10-07
• First posted: 2019-11-18
• Last updated: 2025-12-30
• Results posted: 2022-08-29

Locations

53 sites across 6 countries: United States, Canada, France, Germany, Italy, Japan

Regulatory

• FDA-regulated drug study