Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
Public ClinicalTrials.gov record NCT04569084. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To evaluate and compare the efficacy of two dosing regimens of oral edaravone in subjects with amyotrophic lateral sclerosis (ALS) based on the change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline up to Week 48:
Study identification
- NCT ID
- NCT04569084
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 384 participants
Conditions and interventions
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 12, 2020
- Primary completion
- Sep 28, 2023
- Completion
- Sep 28, 2023
- Last update posted
- Jul 19, 2026
2020 – 2023
United States locations
- U.S. sites
- 34
- U.S. states
- 22
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center (SJHMC) | Phoenix | Arizona | 85013 | — |
| HonorHealth Neurology | Scottsdale | Arizona | 85251 | — |
| Woodland Research Northwest | Rogers | Arkansas | 72758 | — |
| UCSD Medical Center | La Jolla | California | 92037-0897 | — |
| Loma Linda University Health Care - Department of Neurology | Loma Linda | California | 92354 | — |
| University California Los Angeles Medical Center (UCLA) | Los Angeles | California | 90095 | — |
| University of California Irvine (UCI) Health - Women's Healthcare Center | Orange | California | 92868 | — |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| UF Health Cancer Center | Gainesville | Florida | 32610-3633 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC) | Tampa | Florida | 33616 | — |
| Emory University - School of Medicine | Atlanta | Georgia | 30322 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611-2605 | — |
| Ochsner Center for Primary Care and Wellness | Jefferson | Louisiana | 70121 | — |
| Johns Hopkins University | Baltimore | Maryland | 21205 | — |
| Lahey Hospital | Burlington | Massachusetts | 01805 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Neurology Associates, P.C. - Lincoln | Lincoln | Nebraska | 68506-2960 | — |
| Las Vegas Clinic | Las Vegas | Nevada | 89145 | — |
| Dent Neurologic Institute | Amherst | New York | 14226 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Thomas Jefferson University, Jefferson Weinberg ALS Center | Philadelphia | Pennsylvania | 19107 | — |
| Lewis Katz School of Medicine at Temple University | Philadelphia | Pennsylvania | 19140 | — |
| University Of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15261 | — |
| Wesley Neurology Clinic, P.C. | Cordova | Tennessee | 38018 | — |
| Austin Neuromuscular Center | Austin | Texas | 78756 | — |
| Nerve And Muscle Center Of Texas | Houston | Texas | 77019 | — |
| The University of Vermont (UVM) and UVM Medical Center National ALS Center of Excellence | Burlington | Vermont | 05401-3456 | — |
| Sentara Neurology Specialists | Virginia Beach | Virginia | 23456 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| St. Luke's Rehabilitation Institute | Spokane | Washington | 99202 | — |
| West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic | Morgantown | West Virginia | 26506-9180 | — |
| 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 61 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04569084, 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 19, 2026 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04569084 live on ClinicalTrials.gov.