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.Study Status:
Not recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS)
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
MT-1186
Placebo:
No
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Head of Medical Science, Mitsubishi Tanabe Pharma America Inc.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Mitsubishi Tanabe Pharma Development America, Inc.
United States
Study Sponsor:
Mitsubishi Tanabe Pharma America Inc.
Estimated Enrollment:
140
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
Minimum Age:
18 Years
Maximum Age:
N/A
Can participants use Riluzole?
Yes
Inclusion Criteria: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
Exclusion Criteria:
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
Phoenix, Arizona
85013
United States
Neuromuscular Research Center
Phoenix, Arizona
85028
United States
Woodland Research Northwest
Rogers, Arkansas
72758
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado
80045
United States
UF Health Cancer Center
Gainesville, Florida
32610-3633
United States
Emory University - School of Medicine
Atlanta, Georgia
30317-2819
United States
Johns Hopkins University School of Medicine
Baltimore, Maryland
21287
United States
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska
68506-2960
United States
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem, North Carolina
27157-0001
United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania
17025
United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania
19140
United States
Alleghany General Hospital
Pittsburgh, Pennsylvania
15212
United States
Wesley Neurology Clinic, P.C.
Cordova, Tennessee
38018
United States
Texas Neurology, PA
Dallas, Texas
75214
United States
Medical College of Wisconsin
Milwaukee, Wisconsin
53226
United States
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta
T2N 4Z6
Canada
Recherche Sepmus, Inc.
Greenfield Park, Quebec
J4V 2J2
Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec
H3A 2B4
Canada
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta
T6G 2B7
Canada
CHU-Nice - Hopital Pasteur 2
Nice, Cedex 1
06001
France
Centre Hospitalier Esquirol
Limoges, Marcland
87025
France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux 33400
France
Hopital Pierre Wertheimer - Hopital Neurologique
Paris 75013
France
Deutsche Klinik fuer Diagnostik
Wiesbaden, Hessen
65191
Germany
Medizinische Hochschule Hannover
Hannover, Lower Saxony
30625
Germany
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan 20162
Italy
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milano, Lombardia
20132
Italy
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
Turin, Piemonte
10126
Italy
Tokyo Metropolitan Neurological Hospital
Fuchu-city, Tokyo
183-0042
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo
113-8431
Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka-city, Shizuoka
420-8688
Japan
Tohoku University Hospital
Sendai-city, Miyagi
980-8574
Japan
Shiga University of Medical Science Hospital
Otsu-shi, Shiga
520-2192
Japan
National Hospital Organization Toneyama Medical Center
Toyonaka-shi, Osaka
560-8552
Japan
Kansai Electric Power Hospital Recruiting
Fukushima-ku, Osaka-shi, Osaka
553-0003
Japan
Niigata University Medical And Dental Hospital
Niigata-shi, Niigata
951-8520
Japan
Fukushima Medical University Hospital
Fukushima-shi, Fukushima
960-1295
Japan
National Hospital Organization Kumamoto Saishun Medical Center
Koshi-shi, Kumamoto
861-1196
Japan
Yokohama City University Hospital
Yokohama-shi, Kanagawa
236-0004
Japan
Kitasato University Hospital
Sagamihara-city, Kanagawa
252-0375
Japan
Kagawa University Hospital
Kita-gun, Kagawa
761-0793
Japan
National Hospital Organization Iou National Hospital
Kanazawa-shi, Ishikawa
920-0192
Japan
National Hospital Organization Hokkaido Medical Center
Sapporo-shi, Hokkaido
063-0005
Japan
Murakami Karindoh Hospital
Fukuoka-city, Fukuoka
819-8585
Japan
National Hospital Organization Chibahigashi National Hospital
Chiba-shi, Chiba
260-8712
Japan
Aichi Medical University Hospital
Nagakute-shi,, Aichi
480-1195
Japan
Toho University Omori Medical Center
Ota-ku, Tokyo
143-8541
Japan