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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Suspension
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
Number of Patients With AEs and Adverse Drug Reactions
Adverse Event (AE) is classified as treatment emergent if it newly occurred after the first dose of investigational product or if a pre-dose event increases in severity following the first dose of investigational product. Adverse Drug Reaction (ADR) is a noxious and unintended response to a medicinal product that occurs at doses normally used for prophylaxis, diagnosis, or therapy of disease.
Time frame: up to 8 months
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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
...and 1 more locations