drugset / Trial / NCT05568615

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

NCT05568615

Phase 3 Completed 15 enrolled Tanabe Pharma Corporation
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-10-26
Primary completion
2023-06-27
Completion
2023-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Edaravone Unknown 105 mg Oral