Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

  • STATUS
    Recruiting
  • End date
    Jun 5, 2024
  • participants needed
    300
  • sponsor
    Mitsubishi Tanabe Pharma Development America, Inc.
Updated on 5 May 2022
Investigator
Clinical Trials Information Desk, to prevent miscommunication,
Primary Contact
Nerve and Muscle Center of Texas (0.0 mi away) Contact
+8 other location

Summary

To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS), based on the time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

Details
Condition ALS
Treatment Placebo, MT-1186
Clinical Study IdentifierNCT05151471
SponsorMitsubishi Tanabe Pharma Development America, Inc.
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subjects must provide a signed and dated informed consent form 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 must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug

Exclusion Criteria

Subjects of childbearing potential unwilling to use an acceptable method of contraception from the Day 1/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, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit
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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Week 48 of Study MT-1186-A02
Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor
Subjects who are unable to take their medications orally or through a PEG/RIG tube
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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