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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 November 2023
• Main ID: NCT05151471
• Date of registration: 28/11/2021
• Prospective Registration: Yes
• Primary sponsor: Mitsubishi Tanabe Pharma America Inc.
• Public title: Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS
• Scientific title: A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
• Date of first enrolment: January 11, 2022
• Target sample size: 202
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT05151471
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada, Germany, Japan, Korea, Republic of, Switzerland, United Kingdom, United States

Contacts

• Name: Head of Medical Science
• Affiliation: Mitsubishi Tanabe Pharma America Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

ALS

Intervention(s)

Drug: MT-1186

Drug: Placebo

Primary Outcome(s)

Time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in ALSFRS-R or death, whichever happens first. [Time Frame: Up to 96 weeks]

Secondary Outcome(s)

Change in ALSFRS-R score at all visits from baseline in Study MT-1186-A02 to the end of Study MT-1186-A04 [Time Frame: Up to 96 weeks]

Time from the randomization date in Study MT-1186-A02 to death or permanent assisted mechanical ventilation (>23 hours/day) [Time Frame: Up to 96 weeks]

Time from the randomization date in Study MT-1186-A02 to death, tracheostomy, or permanent assisted mechanical ventilation (=23 hours/day) [Time Frame: Up to 96 weeks]

The Combined Assessment of Function and Survival (CAFS) score at all visits from baseline in Study MT-1186-A02 to the end of Study MT-1186-A04 [Time Frame: Up to 96 weeks]

Time from the randomization date in Study MT-1186-A02 to death [Time Frame: Up to 96 weeks]

Change in the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 score at all visits from baseline in Study MT-1186-A02 to the end of Study MT-1186-A04 [Time Frame: Up to 96 weeks]

Secondary ID(s)

MT-1186-A04

Source(s) of Monetary Support

Please refer to primary and secondary sponsors