Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Terminated Phase 3 Interventional Results available

Efficacy and Safety Extension Study of Oral Edaravone Administered in Subjects With ALS

ClinicalTrials.gov ID: NCT05151471

Public ClinicalTrials.gov record NCT05151471. 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 Sep 3, 2026, 4:06 AM EDT

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 Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 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 time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that country

Study identification

NCT ID
NCT05151471
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shionogi
Industry
Enrollment
202 participants

Conditions and interventions

Conditions

Interventions

Drug

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
Jan 10, 2022
Primary completion
Sep 28, 2023
Completion
Sep 28, 2023
Last update posted
Aug 19, 2026

2022 – 2023

United States locations

U.S. sites
10
U.S. states
10
U.S. cities
10
Facility City State ZIP Site status
Woodland Research Northwest, LLC Rogers Arkansas 72758
UF Health Cancer Center/Clinical Trials Office Gainesville Florida 32610-3633
Emory University - School of Medicine Atlanta Georgia 30317-2819
Northwestern University Feinberg School of Medicine Chicago Illinois 60611-2605
Johns Hopkins University Baltimore Maryland 21205
Neurology Associates, P.C - Lincoln Lincoln Nebraska 68506
University Of Pittsburgh Medical Center Pittsburgh Pennsylvania 15213
Nerve And Muscle Center Of Texas Houston Texas 77019
University of Washington Medical Center Seattle Washington 98195
West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic Morgantown West Virginia 26506-9180

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 27 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05151471, 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 Aug 19, 2026 · Synced Sep 3, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05151471 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →