Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Last updated: August 27, 2024
Sponsor: Mitsubishi Tanabe Pharma America Inc.
Overall Status: Completed

Phase

3

Condition

Amyotrophic Lateral Sclerosis (Als)

Neurologic Disorders

Myasthenia Gravis (Chronic Weakness)

Treatment

MT-1186

Clinical Study ID

NCT04577404
MT-1186-A03
jRCT2041200084
2020-000376-38
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects must provide signed and dated informed consent form (ICF) to participate inthe study. Subjects must be able (in the judgment of the Investigator) to understandthe nature of the study and all risks involved with participation in the study.

  2. Subjects must be willing to cooperate and comply with all protocol restrictions andrequirements.

  3. Subjects who successfully completed Study MT-1186-A01.

Exclusion

Exclusion Criteria:

  1. Subjects of childbearing potential unwilling to use a highly effective method ofcontraception from Visit 1 until 3 months after the last dose of study medication.

  2. Subjects who have a significant risk of suicide. Subjects with any suicidal behavioror 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 andintent) based on the C-SSRS at Visit

  3. Subjects who are not eligible to continue in the study, as judged by theInvestigator.

  4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Study Design

Total Participants: 124
Treatment Group(s): 1
Primary Treatment: MT-1186
Phase: 3
Study Start date:
October 29, 2020
Estimated Completion Date:
August 09, 2023

Connect with a study center

  • Heritage Medical Research Clinic - University Of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • Recherche Sepmus, Inc.

    Greenfield Park, Quebec J4V 2J2
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec H3A 2B4
    Canada

    Site Not Available

  • CHU-Nice - Hopital Pasteur 2

    Nice, Cedex 1 06001
    France

    Site Not Available

  • Centre Hospitalier Esquirol

    Limoges, Marcland 87025
    France

    Site Not Available

  • Centre Hospitalier Universitaire (CHU) de Bordeaux

    Bordeaux, 33400
    France

    Site Not Available

  • Hopital Pierre Wertheimer - Hopital Neurologique

    Paris, 75013
    France

    Site Not Available

  • Deutsche Klinik fuer Diagnostik

    Wiesbaden, Hessen 65191
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, Lower Saxony 30625
    Germany

    Site Not Available

  • Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

    Milano, Lombardia 20132
    Italy

    Site Not Available

  • Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

    Turin, Piemonte 10126
    Italy

    Site Not Available

  • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

    Milan, 20162
    Italy

    Site Not Available

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi 480-1195
    Japan

    Site Not Available

  • Aichi Medical University Hospital

    Nagakute-shi,, Aichi 480-1195
    Japan

    Site Not Available

  • National Hospital Organization Chibahigashi National Hospital

    Chiba-shi, Chiba 260-8712
    Japan

    Site Not Available

  • Murakami Karindoh Hospital

    Fukuoka-city, Fukuoka 819-8585
    Japan

    Site Not Available

  • Fukushima Medical University Hospital

    Fukushima-shi, Fukushima 960-1295
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Medical Center

    Sapporo-shi, Hokkaido 063-0005
    Japan

    Site Not Available

  • National Hospital Organization Iou National Hospital

    Kanazawa-shi, Ishikawa 920-0192
    Japan

    Site Not Available

  • Kagawa University Hospital

    Kita-gun, Kagawa 761-0793
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara-city, Kanagawa 252-0375
    Japan

    Site Not Available

  • Yokohama City University Hospital

    Yokohama-shi, Kanagawa 236-0004
    Japan

    Site Not Available

  • National Hospital Organization Kumamoto Saishun Medical Center

    Koshi-shi, Kumamoto 861-1196
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-city, Miyagi 980-8574
    Japan

    Site Not Available

  • Niigata University Medical And Dental Hospital

    Niigata-shi, Niigata 951-8520
    Japan

    Site Not Available

  • Kansai Electric Power Hospital Recruiting

    Fukushima-ku, Osaka-shi, Osaka 553-0003
    Japan

    Site Not Available

  • National Hospital Organization Toneyama Medical Center

    Toyonaka-shi, Osaka 560-8552
    Japan

    Site Not Available

  • Shiga University of Medical Science Hospital

    Otsu-shi, Shiga 520-2192
    Japan

    Site Not Available

  • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

    Shizuoka-city, Shizuoka 420-8688
    Japan

    Site Not Available

  • Juntendo University Hospital

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Tokyo Metropolitan Neurological Hospital

    Fuchu-city, Tokyo 183-0042
    Japan

    Site Not Available

  • Toho University Omori Medical Center

    Ota-ku, Tokyo 143-8541
    Japan

    Site Not Available

  • Neuromuscular Research Center

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • 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

    Site Not Available

  • Woodland Research Northwest

    Rogers, Arkansas 72758
    United States

    Site Not Available

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado 80045
    United States

    Site Not Available

  • UF Health Cancer Center

    Gainesville, Florida 32610-3633
    United States

    Site Not Available

  • Emory University - School of Medicine

    Atlanta, Georgia 30317-2819
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21209
    United States

    Site Not Available

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Neurology Associates, P.C - Lincoln

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Penn State Hershey Children's Hospital

    Hershey, Pennsylvania 17025
    United States

    Site Not Available

  • Lewis Katz School of Medicine at Temple University

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Alleghany General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • Wesley Neurology Clinic, P.C.

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Texas Neurology, PA

    Dallas, Texas 75214
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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