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Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Shionogi
Summary
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
Official title: A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
124
Start Date
2020-10-29
Completion Date
2023-08-09
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
MT-1186
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.
Locations (44)
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
Phoenix, Arizona, United States
Neuromuscular Research Center
Phoenix, Arizona, United States
Woodland Research Northwest
Rogers, Arkansas, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
UF Health Cancer Center
Gainesville, Florida, United States
Emory University - School of Medicine
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska, United States
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem, North Carolina, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States
Texas Neurology, PA
Dallas, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
CHU-Nice - Hopital Pasteur 2
Nice, Cedex 1, France
Centre Hospitalier Esquirol
Limoges, Marcland, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, France
Hopital Pierre Wertheimer - Hopital Neurologique
Paris, France
Deutsche Klinik fuer Diagnostik
Wiesbaden, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Lombardy, Italy
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
Turin, Piedmont, Italy
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan, Italy
Aichi Medical University Hospital
Nagakute-shi, 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
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, Japan
National Hospital Organization Iou National Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Kumamoto Saishun Medical Center
Koshi-shi, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical And Dental Hospital
Niigata, Niigata, Japan
Kansai Electric Power Hospital Recruiting
Fukushima-ku, Osaka-shi, Osaka, Japan
National Hospital Organization Toneyama Medical Center
Toyonaka-shi, Osaka, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Neurological Hospital
Fuchū, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan