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Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
Sponsor: Shionogi
Summary
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country
Official title: A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
202
Start Date
2022-01-11
Completion Date
2023-09-29
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
MT-1186
Oral edaravone
Placebo
Oral
Locations (37)
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
UF Health Cancer Center/Clinical Trials Office
Gainesville, Florida, United States
Emory University - School of Medicine
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska, United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Nerve And Muscle Center Of Texas
Houston, Texas, United States
University of Washington Medical Center
Seattle, Washington, United States
West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic
Morgantown, West Virginia, United States
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, Canada
Health Science Center Mcmaster University
Hamilton, Ontario, Canada
London Health Sciences Centre - University Hospital
London, Ontario, Canada
CHU de Quebec-Hopital-Enfant-Jesus
Québec, Quebec, Canada
Universitaetsklinikum Wuerzburg
Würzburg, Germany
National Hospital Organization Higashinagoya National Hospital
Nagoya, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan
Murakami Karindoh Hospital
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization Iou National Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Kumamoto Saishun Medical Center
Kōshi, Kumamoto, Japan
National Hospital Organization Utano National Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical & Dental Hospital
Niigata, Niigata, Japan
Kansai Electric Power Hospital
Osaka, Osaka, Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka, Osaka, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, Japan
Tokyo Metropolitan Neurological Hospital
Fuchū, Tokyo, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Saitama Neuropsychiatric Institute
Saitama, Japan
Hanyang University Medical Center
Wangsimni-ro, Seongdong-gu, South Korea
Chefarzt Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic
Sankt Gallen, Switzerland