Safety Study of Oral Edaravone Administered in Subjects With ALS
NCT ID: NCT04165824
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
185 participants
INTERVENTIONAL
2019-11-18
2021-10-07
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
MT-1186
* An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
* Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.
Interventions
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MT-1186
* An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
* Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS.
* Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed
* Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%.
* Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent.
Exclusion Criteria
* Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.
* Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
* Subjects who have a significant risk of suicidality. 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 Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.
* Subjects who have ALT or AST elevations greater than 2 times the ULN at screening.
* Subjects with a Glomerular Filtration Rate (GFR) \<30 mL/Min Per 1.73 m2.
* Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
* Subjects with hereditary fructose intolerance.
* Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer before providing informed consent for the present study.
* Subjects who are unable to take their medications orally.
18 Years
75 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
Sutter Health
San Francisco, California, 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
University of Michigan - ALS Center of Excellence
Ann Arbor, Michigan, United States
University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location
Northville, Michigan, United States
Essentia Institute of Rural Health
Duluth, Minnesota, 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
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States
Wesley Neurology Clinic, P.C.
Cordova, Tennessee, United States
Texas Neurology, PA
Dallas, Texas, United States
Houston Methodist Neurological Institute
Houston, Texas, United States
UT Health Science Center San Antonio
San Antonio, Texas, United States
University of Washington Medical Center
Seattle, Washington, 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
Recherche Sepmus, Inc
Greenfield Park, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
CHU Nice-Hospital Archet I
Nice, Alpes Maritimes, France
Centre Hospitalier Esquirol
Limoges, Marcland, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux, , France
Hopital Pierre Wertheimer - Hopital Neurologique
Bron, , France
CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques
Nice, , 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, MI, 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 Chiba-East-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
National Hospital Organization Utano Hospital
Kyoto, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Niigata University Medical And Dental Hospital
Niigata, Niigata, 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
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, Bidani S, Hirai M, Sakata T, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Oral edaravone demonstrated a favorable safety profile in patients with amyotrophic lateral sclerosis after 48 weeks of treatment. Muscle Nerve. 2023 Feb;67(2):124-129. doi: 10.1002/mus.27768. Epub 2022 Dec 28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MT-1186-A01
Identifier Type: -
Identifier Source: org_study_id