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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
France, Other
CHU-Nice - Hopital Pasteur 2, Nice, 06001, France
Japan, Other
National Hospital Organization Chibahigashi National Hospital, Chiba-shi, 260-8712, Japan
Murakami Karindoh Hospital, Fukuoka-city, 819-8585, 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
Niigata University Medical And Dental Hospital, Niigata-shi, 951-8520, Japan
Shiga University of Medical Science Hospital, Otsu-shi, 520-2192, Japan
Kitasato University Hospital, Sagamihara-city, 252-0375, Japan
Tohoku University Hospital, Sendai-city, 980-8574, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka-city, 420-8688, Japan
Yokohama City University Hospital, Yokohama-shi, 236-0004, Japan
United States, Arizona
Neuromuscular Research Center, Phoenix, AZ, 85028, United States
United States, Nebraska
Neurology Associates, P.C - Lincoln, Lincoln, NE, 68506-2960, United States
United States, Pennsylvania
Alleghany General Hospital, Pittsburgh, PA, 15212, 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
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)