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A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

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.

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):

Clinicaltrials.gov ID (11 digit #):

NCT04577404

Neals Affiliated?

No

Coordinating Center Contact Information

Mitsubishi Tanabe Pharma Development America, Inc.
Clinical Trials Information Desk / .(JavaScript must be enabled to view this email address)
.(JavaScript must be enabled to view this email address) United States

Full Study Summary:

Study Sponsor:

Mitsubishi Tanabe Pharma Development America, Inc.

Participant Duration:

Estimated Enrollment:

140

Estimated Study Start Date:

10/29/2020

Estimated Study Completion Date:

09/30/2023

Posting Last Modified Date:

03/23/2021

Date Study Added to alsconsortium.org:

12/30/2020
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Inclusion Criteria:

    1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the 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 and requirements.
    3. Subjects who successfully completed Study MT-1186-A01

    Exclusion Criteria:

    1. Subjects of childbearing potential unwilling to use a highly effective method of contraception 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 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.

  • Site Contact Information

    Neuromuscular Research Center
    Phoenix, Arizona 85028
    United States

    Neurology Associates, P.C - Lincoln
    Lincoln, Nebraska 68506
    United States

    Texas Neurology, PA
    Dallas, Texas 75214
    United States

    National Hospital Organization Chibahigashi National Hospital
    Chiba-shi, Chiba
    Japan

    Murakami Karindoh Hospital
    Fukuoka-city, Fukuoka
    Japan

    Fukushima Medical University Hospital
    Fukushima-shi, Fukushima
    Japan

    Kagawa University Hospital
    Kita-gun, Kagawa
    Japan

    Kitasato University Hospital
    Sagamihara-city, Kanagawa
    Japan

    Yokohama City University Hospital
    Yokohama-shi, Kanagawa
    Japan

    National Hospital Organization Kumamoto Saishun Medical Center
    Koshi-shi, Kumamoto
    Japan

    Shiga University of Medical Science Hospital
    Otsu-shi, Shiga
    Japan

    National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
    Shizuoka-city, Shizuoka
    Japan