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Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05568615
Collaborator
(none)
30
Enrollment
7
Locations
1
Arm
10.2
Anticipated Duration (Months)
4.3
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Actual Study Start Date :
Oct 26, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: MT-1186 orally

Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period.

Drug: MT-1186
Suspension
Other Names:
  • Edaravone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients with AEs and adverse drug reactions [up to 10 months or 31/Aug/2023]

    Other Outcome Measures

    1. ALSFRS-R total score [up to 10 months or 31/Aug/2023]

      The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities.

    2. Number of death, tracheostomy, or permanent assisted mechanical ventilation (≥23 hours/day) [up to 10 months or 31/Aug/2023]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Subjects must provide a 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

    • Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.

    • Subjects who successfully complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%).

    Exclusion Criteria:

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

    • 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 Week 96 of the A03 study or at Week 48 of the A04 study.

    • Subjects who are not eligible to continue in the study, as judged by the Investigator.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Hospital Organization Chibahigashi National Hospital Chiba-shi Chiba Japan 260-8712
    2 Fukushima Medical University Hospital Fukushima-shi Fukushima Japan 960-1295
    3 Kagawa University Hospital Kita-gun Kagawa Japan 761-0793
    4 Yokohama City University Hospital Yokohama-shi Kanagawa Japan 236-0004
    5 National Hospital Organization Kumamoto Saishun Medical Center Koshi Kumamoto Japan 861-1196
    6 Shiga University of Medical Science Hospital Otsu-shi Shiga Japan 520-2192
    7 National Epilepsy Center NHO Shizuoka Institute of Epilepsy and Neurological Disorders Shizuoka Japan 420-8688

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT05568615
    Other Study ID Numbers:
    • MT-1186-A-301
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Jan 18, 2023
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Edaravone

    Study Results

    No Results Posted as of Jan 18, 2023