Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT ID: NCT04577404
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
124 participants
INTERVENTIONAL
2020-10-29
2023-08-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MT-1186
Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period
MT-1186
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.
Interventions
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MT-1186
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Tanabe Pharma America, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Head of Medical Science
Role: STUDY_DIRECTOR
Tanabe Pharma America, Inc.
Locations
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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, United States
Neuromuscular Research Center
Phoenix, Arizona, United States
Woodland Research Northwest
Rogers, Arkansas, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
UF Health Cancer Center
Gainesville, Florida, United States
Emory University - School of Medicine
Atlanta, Georgia, United States
Johns Hopkins University
Baltimore, Maryland, United States
Neurology Associates, P.C - Lincoln
Lincoln, Nebraska, United States
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
Winston-Salem, North Carolina, United States
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States
Texas Neurology, PA
Dallas, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
CHU-Nice - Hopital Pasteur 2
Nice, Cedex 1, France
Centre Hospitalier Esquirol
Limoges, Marcland, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, , France
Hopital Pierre Wertheimer - Hopital Neurologique
Paris, , France
Deutsche Klinik fuer Diagnostik
Wiesbaden, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milan, Lombardy, Italy
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
Turin, Piedmont, Italy
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan, , Italy
Aichi Medical University Hospital
Nagakute-shi, Aichi-ken, Japan
National Hospital Organization Chibahigashi National Hospital
Chiba, Chiba, Japan
Murakami Karindoh Hospital
Fukuoka, Fukuoka, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
National Hospital Organization Hokkaido Medical Center
Sapporo, Hokkaido, Japan
National Hospital Organization Iou National Hospital
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
National Hospital Organization Kumamoto Saishun Medical Center
Koshi-shi, Kumamoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical And Dental Hospital
Niigata, Niigata, Japan
Kansai Electric Power Hospital Recruiting
Fukushima-ku, Osaka-shi, Osaka, Japan
National Hospital Organization Toneyama Medical Center
Toyonaka-shi, Osaka, Japan
Shiga University of Medical Science Hospital
Ōtsu, Shiga, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Shizuoka, Shizuoka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Tokyo Metropolitan Neurological Hospital
Fuchū, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Countries
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References
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Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Todorovic V, Sasson N, Hirai M, Takahashi F, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Safety Extension Study of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis for up to an Additional 96 Weeks of Treatment. Muscle Nerve. 2025 Sep;72(3):450-454. doi: 10.1002/mus.28451. Epub 2025 Jun 9.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-000376-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
jRCT2041200084
Identifier Type: REGISTRY
Identifier Source: secondary_id
MT-1186-A03
Identifier Type: -
Identifier Source: org_study_id