Safety Study of Oral Edaravone Administered in Subjects With ALS

Study Purpose:

The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Study Status:

Not recruiting


Amyotrophic Lateral Sclerosis (ALS) , Familial ALS , Sporadic ALS

Study Type:


Type of Intervention:

Drug Trial

Intervention Name:




Phase 3

Study Chair(s)/Principal Investigator(s):

Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc. ID:


Neals Affiliated?


Coordinating Center Contact Information

Clinical Trials Information Desk / email hidden; JavaScript is required

Study Sponsor:

Mitsubishi Tanabe Pharma Development America, Inc.

Estimated Enrollment:


Estimated Study Start Date:

11 / 18 / 2019

Estimated Study Completion Date:

06 / 30 / 2021

Posting Last Modified Date:

10 / 13 / 2020

Date Study Added to

12 / 18 / 2019

Minimum Age:


Maximum Age:


Can participants use Riluzole?


Inclusion Criteria:

  • Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed
  • 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 who have the presence or history of any clinically significant disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
  • 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.

Barrow Neurological Institute

Phoenix, Arizona 85013
United States

Neuromuscular Research Center

Phoenix, Arizona 85028
United States

Woodland Research Northwest

Rogers, Arkansas 72758
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Sutter Health

San Francisco, California 94115
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University of Colorado Anschutz Medical Campus

Aurora, Colorado 80045
United States

UF Health

Gainesville, Florida 32610
United States

Emory University School of Medicine

Atlanta, Georgia 30317
United States

Massachusetts General Hospital

Boston, Massachusetts 02114
United States

University of Michigan Health System

Northville, Michigan 48168
United States

Essentia Institute of Rural Health

Duluth, Minnesota 55805
United States

Neurology Associates, P.C

Lincoln, Nebraska 68506
United States

Wake Forest University

Winston-Salem, North Carolina 27157
United States

Penn State

Hershey, Pennsylvania 17025
United States

Alleghany General Hospital

Pittsburgh, Pennsylvania 15212
United States

Wesley Nuerology Clinic, P.C.

Cordova, Tennessee 38018
United States

Texas Neurology, PA

Dallas, Texas 75214
United States

Houston Methodist Neurological Institute

Houston, Texas 77030
United States

UT Health Science Center San Antonio

San Antonio, Texas 78229
United States

University of Washington Medical Center

Seattle, Washington 98195
United States

Medical College of Wisconsin

Milwaukee, Wisconsin 53226
United States

University of Alberta

Edmonton, Alberta

Recherche Sepmus, Inc

Greenfield Park, Quebec

Montreal Nuerological Institute and Hospital

Montreal, Quebec

CHU Nice-Hopital Archet

Nice cedex 3, Alpes Maritimes

Centre Hospitalier Esquirol

Limoges, Marcland

Universita degli Studi di Torino

Turin, Piemonte