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

  • STATUS
    Recruiting
  • End date
    Sep 27, 2023
  • participants needed
    140
  • sponsor
    Mitsubishi Tanabe Pharma Development America, Inc.
Updated on 27 September 2021
primary lateral sclerosis
edaravone

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.

Details
Condition Myelopathy, Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis (ALS), Spinal Cord Disorders, lou gehrig's disease
Treatment MT-1186
Clinical Study IdentifierNCT04577404
SponsorMitsubishi Tanabe Pharma Development America, Inc.
Last Modified on27 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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
Subjects must be willing to cooperate and comply with all protocol restrictions and requirements
Subjects who successfully completed Study MT-1186-A01

Exclusion Criteria

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
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
Subjects who are not eligible to continue in the study, as judged by the Investigator
Subjects who are unable to take their medications orally or through a PEG/RIG tube
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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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