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.

Disease:

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

Study Type:

Interventional Trial

Study Category:

Drug Trial

Study Status:

Enrolling

Phase:

Phase III

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

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

Clinicaltrials.gov ID (11 digit #):

NCT04165824

Neals Affiliated?

No

Coordinating Center Contact Information


Clinical Trials Information Desk / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address)

Full Study Summary:

Study Sponsor:

Mitsubishi Tanabe Pharma Development America, Inc.

Participant Duration:

Estimated Enrollment:

150

Estimated Study Start Date:

11/18/2019

Estimated Study Completion Date:

06/30/2021

Posting Last Modified Date:

08/25/2020

Date Study Added to alsconsortium.org:

12/18/2019
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    75

    Min Vital Capacity (% predicted normal):

    70

    Time since Symptom Onset:

    <36 months

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    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.

  • Site Contact Information

    Barrow Neurological Institute
    Phoenix, Arizona 85013
    United States

    Neuromuscular Research Center
    Phoenix, Arizona 85028
    United States

    Woodland Research Northwest
    Rogers, Arkansas 72758
    United States

    Sutter Health
    San Francisco, California 94115
    United States

    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
    Canada

    Recherche Sepmus, Inc
    Greenfield Park, Quebec
    Canada

    Montreal Nuerological Institute and Hospital
    Montreal, Quebec
    Canada

    CHU Nice-Hopital Archet
    Nice cedex 3, Alpes Maritimes
    France

    Centre Hospitalier Esquirol
    Limoges, Marcland
    France

    Universita degli Studi di Torino
    Turin, Piemonte
    Italy