NCT05568615

Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Conditions

• ALS

Interventions

Type	Name	Description
DRUG	MT-1186	Suspension

Timeline

• Start date: 2022-10-26
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2022-10-05
• Last updated: 2025-12-30
• Results posted: 2025-02-03

Locations

11 sites across 1 country: Japan