Study Purpose: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.
Amyotrophic Lateral Sclerosis (ALS)
Type of Intervention:
Study Chair(s)/Principal Investigator(s):
Head of Medical Science, Mitsubishi Tanabe Pharma America Inc.
Coordinating Center Contact Information
Mitsubishi Tanabe Pharma Development America, Inc.
Mitsubishi Tanabe Pharma America Inc.
Estimated Study Start Date:
10 / 29 / 2020
Estimated Study Completion Date:
09 / 01 / 2023
Posting Last Modified Date:
05 / 15 / 2023
Date Study Added to neals.org:
10 / 06 / 2020
Can participants use Riluzole?
1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
3. Subjects who successfully completed Study MT-1186-A01
1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
2. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Visit
3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
Neuromuscular Research Center
Woodland Research Northwest
University of Colorado Anschutz Medical Campus
UF Health Cancer Center
Emory University - School of Medicine
Johns Hopkins University School of Medicine
Neurology Associates, P.C - Lincoln
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem, North Carolina
Penn State Hershey Children's Hospital
Lewis Katz School of Medicine at Temple University
Alleghany General Hospital
Wesley Neurology Clinic, P.C.
Texas Neurology, PA
Medical College of Wisconsin
Heritage Medical Research Clinic - University Of Calgary
Recherche Sepmus, Inc.
Greenfield Park, Quebec
Montreal Neurological Institute and Hospital
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
CHU-Nice - Hopital Pasteur 2
Nice, Cedex 1
Centre Hospitalier Esquirol
Centre Hospitalier Universitaire (CHU) de Bordeaux
Hopital Pierre Wertheimer - Hopital Neurologique
Deutsche Klinik fuer Diagnostik
Medizinische Hochschule Hannover
Hannover, Lower Saxony
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
Tokyo Metropolitan Neurological Hospital
Juntendo University Hospital
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Tohoku University Hospital
Shiga University of Medical Science Hospital
National Hospital Organization Toneyama Medical Center
Kansai Electric Power Hospital Recruiting
Fukushima-ku, Osaka-shi, Osaka
Niigata University Medical And Dental Hospital
Fukushima Medical University Hospital
National Hospital Organization Kumamoto Saishun Medical Center
Yokohama City University Hospital
Kitasato University Hospital
Kagawa University Hospital
National Hospital Organization Iou National Hospital
National Hospital Organization Hokkaido Medical Center
Murakami Karindoh Hospital
National Hospital Organization Chibahigashi National Hospital
Aichi Medical University Hospital
Toho University Omori Medical Center