Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Public ClinicalTrials.gov record NCT04577404. 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 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.
Study identification
- NCT ID
- NCT04577404
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 124 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Oct 28, 2020
- Primary completion
- Aug 8, 2023
- Completion
- Aug 8, 2023
- Last update posted
- Jul 19, 2026
2020 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| 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 | — |
| 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 | 21209 | — |
| Neurology Associates, P.C - Lincoln | Lincoln | Nebraska | 68506 | — |
| Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation | Winston-Salem | North Carolina | 27157 | — |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17025 | — |
| Alleghany General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Texas Neurology, PA | Dallas | Texas | 75214 | — |
| 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 NCT04577404, 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 NCT04577404 live on ClinicalTrials.gov.