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Completed Phase 3 Interventional Results available

Safety Study of Oral Edaravone Administered in Subjects With ALS

ClinicalTrials.gov ID: NCT04165824

Public ClinicalTrials.gov record NCT04165824. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 17, 2026, 2:37 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04165824
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shionogi
Industry
Enrollment
185 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 18, 2019 (Actual)
Primary completion
Oct 7, 2021 (Actual)
Completion
Oct 7, 2021 (Actual)
Last update posted
Jul 21, 2026

2019 – 2021

United States locations

U.S. sites
22
U.S. states
16
U.S. cities
21
Facility City State ZIP Site status
St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center Phoenix Arizona 85013 —
Neuromuscular Research Center Phoenix Arizona 85028 —
Woodland Research Northwest Rogers Arkansas 72758 —
Sutter Health San Francisco California 94115 —
University of Colorado Anschutz Medical Campus Aurora Colorado 80045 —
UF Health Cancer Center Gainesville Florida 32610-3633 —
Emory University - School of Medicine Atlanta Georgia 30317-2819 —
Johns Hopkins University Baltimore Maryland 21205 —
University of Michigan - ALS Center of Excellence Ann Arbor Michigan 48109-5223 —
University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location Northville Michigan 48168-9493 —
Essentia Institute of Rural Health Duluth Minnesota 55805 —
Neurology Associates, P.C - Lincoln Lincoln Nebraska 68506-2960 —
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation Winston-Salem North Carolina 27157-0001 —
Penn State Hershey Children's Hospital Hershey Pennsylvania 17025 —
Lewis Katz School of Medicine at Temple University Philadelphia Pennsylvania 19140 —
Alleghany General Hospital Pittsburgh Pennsylvania 15212 —
Wesley Neurology Clinic, P.C. Cordova Tennessee 38018 —
Texas Neurology, PA Dallas Texas 75214 —
Houston Methodist Neurological Institute Houston Texas 77030 —
UT Health Science Center San Antonio San Antonio Texas 78229 —
University of Washington Medical Center Seattle Washington 98195 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04165824, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 21, 2026 · Synced Oct 17, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04165824 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →