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

NCT04569084 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2026-05-22

Study results available
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Summary

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:

Conditions

Interventions

DRUG

MT-1186

Oral edaravone

DRUG

Placebo

Oral

Sponsors & Collaborators

  • Tanabe Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Head of Medical Science · Tanabe Pharma America, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2023-09-29
Completion
2023-09-29
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Japan
  • South Korea
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04569084 on ClinicalTrials.gov