Safety Study of Oral Edaravone Administered in Subjects With ALS
Condition: ALS
Intervention: MT-1186
Intervention description: An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.
Intervention MeSH terms: Edaravone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the long-term safety and tolerability of oral
      edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed

          -  Subjects will be diagnosed with Definite ALS, Probable ALS, Probable
             laboratory-supported ALS, or Possible ALS according to the El Escorial revised
             criteria for the diagnosis of ALS.

          -  Subjects will be living and functioning independently (eg, able to eat, excrete,
             ambulate independently without assistance of others). The use of supportive tools and
             adaptive utensil is allowed

          -  Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%.

          -  Subjects whose first symptom of ALS occurred within 3 years of the time of providing
             written informed consent.

        Exclusion Criteria:

          -  Subjects who have the presence or history of any clinically significant disease
             (except ALS) that could interfere with the objectives of the study (the assessment of
             safety and efficacy) or the safety of the subject, as judged by the Investigator.

          -  Subjects of childbearing potential unwilling to use acceptable method of contraception
             from the 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 and pregnant (a positive pregnancy test) or lactating at the
             screening visit (Visit 1).

          -  Subjects who have a significant risk of suicidality. 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) within the 3
             months before the screening visit.

          -  Subjects who have ALT or AST elevations greater than 2 times the ULN at screening.

          -  Subjects with a Glomerular Filtration Rate (GFR) <30 mL/Min Per 1.73 m2.

          -  Subjects with history of hypersensitivity to edaravone, any of the additives or
             inactive ingredients of edaravone, or sulfites.

          -  Subjects with hereditary fructose intolerance.

          -  Subjects who participated in another study and were administered an investigational
             product within 1 month or 5 half-lives of the investigational agent, whichever is
             longer before providing informed consent for the present study.

          -  Subjects who are unable to take their medications orally.