Multiple Sclerosis Clinical Trial
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Summary
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 Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
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There are 47 Locations for this study
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85028, United States
Rogers Arkansas, 72758, United States
Aurora Colorado, 80045, United States
Gainesville Florida, 32610, United States
Atlanta Georgia, 30317, United States
Baltimore Maryland, 21287, United States
Lincoln Nebraska, 68506, United States
Winston-Salem North Carolina, 27157, United States
Hershey Pennsylvania, 17025, United States
Philadelphia Pennsylvania, 19140, United States
Pittsburgh Pennsylvania, 15212, United States
Cordova Tennessee, 38018, United States
Dallas Texas, 75214, United States
Milwaukee Wisconsin, 53226, United States
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Greenfield Park Quebec, J4V 2, Canada
Montreal Quebec, H3A 2, Canada
Nice Cedex 1, 06001, France
Limoges Marcland, 87025, France
Bordeaux , 33400, France
Paris , 75013, France
Wiesbaden Hessen, 65191, Germany
Hannover Lower Saxony, 30625, Germany
Milano Lombardia, 20132, Italy
Turin Piemonte, 10126, Italy
Milan , 20162, Italy
Nagakute-shi, Aichi, 480-1, Japan
Chiba-shi Chiba, 260-8, Japan
Fukuoka-city Fukuoka, 819-8, Japan
Fukushima-shi Fukushima, 960-1, Japan
Sapporo-shi Hokkaido, 063-0, Japan
Kanazawa-shi Ishikawa, 920-0, Japan
Kita-gun Kagawa, 761-0, Japan
Sagamihara-city Kanagawa, 252-0, Japan
Yokohama-shi Kanagawa, 236-0, Japan
Koshi-shi Kumamoto, 861-1, Japan
Sendai-city Miyagi, 980-8, Japan
Niigata-shi Niigata, 951-8, Japan
Fukushima-ku, Osaka-shi Osaka, 553-0, Japan
Toyonaka-shi Osaka, 560-8, Japan
Otsu-shi Shiga, 520-2, Japan
Shizuoka-city Shizuoka, 420-8, Japan
Bunkyo-ku Tokyo, 113-8, Japan
Fuchu-city Tokyo, 183-0, Japan
Ota-ku Tokyo, 143-8, Japan
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