A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Chair(s)/Principal Investigator(s):
Clinicaltrials.gov ID (11 digit #):NCT04577404
Coordinating Center Contact InformationMitsubishi Tanabe Pharma Development America, Inc.
Full Study Summary:
Study Sponsor:Mitsubishi Tanabe Pharma Development America, Inc.
Estimated Study Start Date:10/29/2020
Estimated Study Completion Date:09/30/2023
Posting Last Modified Date:03/23/2021
Date Study Added to alsconsortium.org:12/30/2020
Time since Symptom Onset:
Time since Diagnosis:
Can participants use Riluzole?Yes
- 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.
- Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
- Subjects who successfully completed Study MT-1186-A01
- 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.
- 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
- Subjects who are not eligible to continue in the study, as judged by the Investigator.
- Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Site Contact Information
Neuromuscular Research Center
Phoenix, Arizona 85028
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska 68506
Texas Neurology, PA
Dallas, Texas 75214
National Hospital Organization Chibahigashi National Hospital
Murakami Karindoh Hospital
Fukushima Medical University Hospital
Kagawa University Hospital
Kitasato University Hospital
Yokohama City University Hospital
National Hospital Organization Kumamoto Saishun Medical Center
Shiga University of Medical Science Hospital
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders