Safety Study of Oral Edaravone Administered in Subjects With ALS

Completed · Phase 3

Conditions studied: ALS

In brief

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.

Key facts

Study ID

NCT04165824

Run by

Shionogi

People needed

185

Starts

2019-11-18

Expected to finish

2021-10-07

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Essentia Institute of Rural Health — Duluth, Minnesota, United States
• Neurology Associates, P.C - Lincoln — Lincoln, Nebraska, United States
• Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation — Winston-Salem, North Carolina, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Lewis Katz School of Medicine at Temple University — Philadelphia, Pennsylvania, United States
• Alleghany General Hospital — Pittsburgh, Pennsylvania, United States
• Wesley Neurology Clinic, P.C. — Cordova, Tennessee, United States
• Texas Neurology, PA — Dallas, Texas, United States
• Houston Methodist Neurological Institute — Houston, Texas, United States
• UT Health Science Center San Antonio — San Antonio, Texas, United States
• University of Washington Medical Center — Seattle, Washington, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Heritage Medical Research Clinic - University Of Calgary — Calgary, Alberta, Canada
• University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM) — Edmonton, Alberta, Canada
• Recherche Sepmus, Inc — Greenfield Park, Quebec, Canada
• 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

Full record on ClinicalTrials.gov

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