Safety Study of Oral Edaravone Administered in Subjects With ALS
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.
Disease:Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS
Study Type:Interventional Trial
Study Category:Drug Trial
Study Chair(s)/Principal Investigator(s):
Head of Clinical Development, Mitsubishi Tanabe Pharma Development America, Inc.
Clinicaltrials.gov ID (11 digit #):NCT04165824
Coordinating Center Contact Information
Full Study Summary:
Study Sponsor:Mitsubishi Tanabe Pharma Development America, Inc.
Estimated Study Start Date:11/18/2019
Estimated Study Completion Date:06/30/2021
Posting Last Modified Date:06/30/2021
Date Study Added to alsconsortium.org:12/18/2019
Time since Symptom Onset:<36 months
Time since Diagnosis:
Can participants use Riluzole?Yes
- 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.
- 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.
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