Safety Study of Oral Edaravone Administered in Subjects With ALS

Phase 3

Completed

Conditions: ALS

Interventions: Drug: MT-1186

Registration Number: NCT04165824

Lead Sponsor: Mitsubishi Tanabe Pharma America Inc.

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 185

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-1186	MT-1186	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment Emergency Adverse Events	Up to 48 Weeks
Number of Treatment Emergency Adverse Events	up to 48 Weeks

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (53): St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
🇺🇸
Phoenix, Arizona, United States
Neuromuscular Research Center
🇺🇸
Phoenix, Arizona, United States
Woodland Research Northwest
🇺🇸
Rogers, Arkansas, United States
Sutter Health
🇺🇸
San Francisco, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸
Aurora, Colorado, United States
UF Health Cancer Center
🇺🇸
Gainesville, Florida, United States
Emory University - School of Medicine
🇺🇸
Atlanta, Georgia, United States
Johns Hopkins University
🇺🇸
Baltimore, Maryland, United States
University of Michigan - ALS Center of Excellence
🇺🇸
Ann Arbor, Michigan, United States
University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location
🇺🇸
Northville, Michigan, United States
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St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
🇺🇸Phoenix, Arizona, United States