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

Overview

About this study

The purpose of this study is to evaluate and compare the effectiveness 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Subjects or their legally authorized representative must provide a signed and dated
informed consent form to participate in the study.

2. 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.

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

4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been
compliant with study drug.

Exclusion Criteria:

1. 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.

2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy
test) or lactating at the Day 1/screening visit.

3. 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.

4. Subjects who are not eligible to continue in the study, as judged by the Investigator
in conjunction with the MTDA medical monitor.

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/6/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Bjorn Oskarsson, M.D.

Open for enrollment

Contact information:

Lisa Thuro

Thuro.Lisa@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Nathan Staff, M.D., Ph.D.

Open for enrollment

Contact information:

Jonathan Duff

(507) 538-0266

Duff.Jonathan@mayo.edu

More information

Publications

Publications are currently not available
.
CLS-20536234

Mayo Clinic Footer