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Quick Info
Status
Currently Recruiting
Phase
3
Trial Type
Interventional
Treatment Type
Drug Trials
Randomization
Unknown
Enrollment
140
Start Date
10/29/2020
Contact Information
    Contact information unknown.
Locations
Canada, Alberta
Heritage Medical Research Clinic - University Of Calgary, Calgary, AB, T2N 4Z6, Canada
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM), Edmonton, AB, T6G 2B7, Canada
Canada, Quebec
Recherche Sepmus, Inc., Greenfield Park, QC, J4V 2J2, Canada
Montreal Neurological Institute and Hospital, Montreal, QC, H3A 2B4, Canada
France, Other
Centre Hospitalier Universitaire (CHU) de Bordeaux, Bordeaux, 33400, France
Centre Hospitalier Esquirol, Limoges, 87025, France
CHU-Nice - Hopital Pasteur 2, Nice, 06001, France
Hopital Pierre Wertheimer - Hopital Neurologique, Paris, 75013, France
Germany, Other
Medizinische Hochschule Hannover, Hannover, 30625, Germany
Deutsche Klinik fuer Diagnostik, Wiesbaden, 65191, Germany
Italy, Other
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscul, Milan, 20162, Italy
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele), Milano, 20132, Italy
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CR, Turin, 10126, Italy
Japan, Other
Juntendo University Hospital, Bunkyo-ku, 113-8431, Japan
National Hospital Organization Chibahigashi National Hospital, Chiba-shi, 260-8712, Japan
Tokyo Metropolitan Neurological Hospital, Fuchu-city, 183-0042, Japan
Murakami Karindoh Hospital, Fukuoka-city, 819-8585, Japan
Kansai Electric Power Hospital Recruiting, Fukushima-ku, Osaka-shi, 553-0003, Japan
Fukushima Medical University Hospital, Fukushima-shi, 960-1295, Japan
National Hospital Organization Iou National Hospital, Kanazawa-shi, 920-0192, Japan
Kagawa University Hospital, Kita-gun, 761-0793, Japan
National Hospital Organization Kumamoto Saishun Medical Center, Koshi-shi, 861-1196, Japan
Aichi Medical University Hospital, Nagakute-shi,, 480-1195, Japan
Niigata University Medical And Dental Hospital, Niigata-shi, 951-8520, Japan
Toho University Omori Medical Center, Ota-ku, 143-8541, Japan
Shiga University of Medical Science Hospital, Otsu-shi, 520-2192, Japan
Kitasato University Hospital, Sagamihara-city, 252-0375, Japan
National Hospital Organization Hokkaido Medical Center, Sapporo-shi, 063-0005, Japan
Tohoku University Hospital, Sendai-city, 980-8574, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka-city, 420-8688, Japan
National Hospital Organization Toneyama Medical Center, Toyonaka-shi, 560-8552, Japan
Yokohama City University Hospital, Yokohama-shi, 236-0004, Japan
United States, Arizona
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory, Phoenix, AZ, 85013, United States
Neuromuscular Research Center, Phoenix, AZ, 85028, United States
United States, Arkansas
Woodland Research Northwest, Rogers, AR, 72758, United States
United States, Colorado
University of Colorado Anschutz Medical Campus, Aurora, CO, 80045, United States
United States, Florida
UF Health Cancer Center, Gainesville, FL, 32610-3633, United States
United States, Georgia
Emory University - School of Medicine, Atlanta, GA, 30317-2819, United States
United States, Maryland
Johns Hopkins University School of Medicine, Baltimore, MD, 21287, United States
United States, Nebraska
Neurology Associates, P.C - Lincoln, Lincoln, NE, 68506-2960, United States
United States, North Carolina
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Reha, Winston-Salem, NC, 27157-0001, United States
United States, Pennsylvania
Penn State Hershey Children's Hospital, Hershey, PA, 17025, United States
Lewis Katz School of Medicine at Temple University, Philadelphia, PA, 19140, United States
Alleghany General Hospital, Pittsburgh, PA, 15212, United States
United States, Tennessee
Wesley Neurology Clinic, P.C., Cordova, TN, 38018, United States
United States, Texas
Texas Neurology, PA, Dallas, TX, 75214, United States
United States, Wisconsin
Medical College of Wisconsin, Milwaukee, WI, 53226, United States
Enrollment Criteria
Breathing Ability
Percent lung function (FVC) or (SVC)
N/A
Months Since Onset
Number of months since first symptoms of ALS.
N/A
Non-Invasive Ventilation (NIV)
Can PALS use a BiPAP in the trial?
N/A
Diaphragm Pacer (DPS)
Can PALS use a DPS in the trial?
N/A
Edaravone Usage
Can a PALS use edaravone (Radicut/Radicava) while enrolled in the trial?
Yes
Open Label
Yes
Update Notes
Site contact updates
9/20/2021
New sites added
9/8/2021
New site added
8/23/2021
Added locations in Florida, Canada, and Italy.
7/23/2021
New sites added
7/16/2021
New sites added
7/13/2021
New sites added
6/28/2021
New sites added
6/7/2021
New sites added
3/10/2021
New site added
1/29/2021
New sites added
1/22/2021
New sites added
1/13/2021
Enrollment increased, sites added
11/13/2020
Inclusion/exclusion criteria updated
10/20/2020

Other Information

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.
Eligibility
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.
Details
Collaborator(s)
  • Mitsubishi Tanabe Pharma Development America, Inc.
Trial Protocol as Published on Clinicaltrials.gov
NCT04577404 (First Published: 9/30/2020)