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Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS
Sponsor: Tanabe Pharma Corporation
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2022-10-26
Completion Date
2023-06-27
Last Updated
2026-05-08
Healthy Volunteers
No
Conditions
Interventions
MT-1186
Suspension
Locations (11)
National Hospital Organization Higashinagoya National Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Kumamoto Saishun Medical Center
Kōshi, Kumamoto, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-shi, Osaka, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
Tokyo Metropolitan Neurological Hospital
Fuchu-shi, Tokyo, Japan
National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Japan