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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

140

Study ID:

NCT04577404

Recruitment Status:

Active, not recruiting

Sponsor:

Mitsubishi Tanabe Pharma America Inc.

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There are 47 Locations for this study

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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, United States
Emory University - School of Medicine
Atlanta Georgia, 30317, United States
Johns Hopkins University School of Medicine
Baltimore Maryland, 21287, United States
Neurology Associates, P.C - Lincoln
Lincoln Nebraska, 68506, United States
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem North Carolina, 27157, 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 4, Canada
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton Alberta, T6G 2, Canada
Recherche Sepmus, Inc.
Greenfield Park Quebec, J4V 2, Canada
Montreal Neurological Institute and Hospital
Montreal Quebec, H3A 2, 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
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
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan , 20162, Italy
Aichi Medical University Hospital
Nagakute-shi, Aichi, 480-1, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba-shi Chiba, 260-8, Japan
Murakami Karindoh Hospital
Fukuoka-city Fukuoka, 819-8, Japan
Fukushima Medical University Hospital
Fukushima-shi Fukushima, 960-1, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo-shi Hokkaido, 063-0, Japan
National Hospital Organization Iou National Hospital
Kanazawa-shi Ishikawa, 920-0, Japan
Kagawa University Hospital
Kita-gun Kagawa, 761-0, Japan
Kitasato University Hospital
Sagamihara-city Kanagawa, 252-0, Japan
Yokohama City University Hospital
Yokohama-shi Kanagawa, 236-0, Japan
National Hospital Organization Kumamoto Saishun Medical Center
Koshi-shi Kumamoto, 861-1, Japan
Tohoku University Hospital
Sendai-city Miyagi, 980-8, Japan
Niigata University Medical And Dental Hospital
Niigata-shi Niigata, 951-8, Japan
Kansai Electric Power Hospital Recruiting
Fukushima-ku, Osaka-shi Osaka, 553-0, Japan
National Hospital Organization Toneyama Medical Center
Toyonaka-shi Osaka, 560-8, Japan
Shiga University of Medical Science Hospital
Otsu-shi Shiga, 520-2, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka-city Shizuoka, 420-8, Japan
Juntendo University Hospital
Bunkyo-ku Tokyo, 113-8, Japan
Tokyo Metropolitan Neurological Hospital
Fuchu-city Tokyo, 183-0, Japan
Toho University Omori Medical Center
Ota-ku Tokyo, 143-8, Japan

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

140

Study ID:

NCT04577404

Recruitment Status:

Active, not recruiting

Sponsor:


Mitsubishi Tanabe Pharma America Inc.

How clear is this clinincal trial information?

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