Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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 Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Intervention / Treatment: Drug: MT-1186

• Study Type: Interventional
• Enrollment (Actual): 124
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Heritage Medical Research Clinic - University Of Calgary
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
  • Quebec
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
• France
  • Bordeaux, France, 33400
    • Centre Hospitalier Universitaire (CHU) de Bordeaux
  • Paris, France, 75013
    • Hopital Pierre Wertheimer - Hopital Neurologique
  • Cedex 1
    • Nice, Cedex 1, France, 06001
      • CHU-Nice - Hopital Pasteur 2
  • Marcland
    • Limoges, Marcland, France, 87025
      • Centre Hospitalier Esquirol
• Germany
  • Hesse
    • Wiesbaden, Hesse, Germany, 65191
      • Deutsche Klinik fuer Diagnostik
  • Lower Saxony
    • Hanover, Lower Saxony, Germany, 30625
      • Medizinische Hochschule Hannover
• Italy
  • Milan, Italy, 20162
    • Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
  • Piedmont
    • Turin, Piedmont, Italy, 10126
      • Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
• Japan
  • Aichi-ken
    • Nagakute-shi, Aichi-ken, Japan, 480-1195
      • Aichi Medical University Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8712
      • National Hospital Organization Chibahigashi National Hospital
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 819-8585
      • Murakami Karindoh Hospital
  • Fukushima
    • Fukushima, Fukushima, Japan, 960-1295
      • Fukushima Medical University Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 063-0005
      • National Hospital Organization Hokkaido Medical Center
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-0192
      • National Hospital Organization Iou National Hospital
  • Kagawa-ken
    • Kita-gun, Kagawa-ken, Japan, 761-0793
      • Kagawa University Hospital
  • Kanagawa
    • Sagamihara, Kanagawa, Japan, 252-0375
      • Kitasato University Hospital
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital
  • Kumamoto
    • Koshi-shi, Kumamoto, Japan, 861-1196
      • National Hospital Organization Kumamoto Saishun Medical Center
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Niigata
    • Niigata, Niigata, Japan, 951-8520
      • Niigata University Medical and Dental Hospital
  • Osaka
    • Fukushima-ku, Osaka-shi, Osaka, Japan, 553-0003
      • Kansai Electric Power Hospital Recruiting
    • Toyonaka-shi, Osaka, Japan, 560-8552
      • National Hospital Organization Toneyama Medical Center
  • Shiga
    • Ōtsu, Shiga, Japan, 520-2192
      • Shiga University of Medical Science Hospital
  • Shizuoka
    • Shizuoka, Shizuoka, Japan, 420-8688
      • National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Juntendo University Hospital
    • Fuchū, Tokyo, Japan, 183-0042
      • Tokyo Metropolitan Neurological Hospital
    • Ōta-ku, Tokyo, Japan, 143-8541
      • Toho University Omori Medical Center
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center
    • Phoenix, Arizona, United States, 85028
      • Neuromuscular Research Center
  • Arkansas
    • Rogers, Arkansas, United States, 72758
      • Woodland Research Northwest
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus
  • Florida
    • Gainesville, Florida, United States, 32610-3633
      • UF Health Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30317-2819
      • Emory University - School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • Johns Hopkins University
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Neurology Associates, P.C - Lincoln
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17025
      • Penn State Hershey Children's Hospital
    • Pittsburgh, Pennsylvania, United States, 15212
      • Alleghany General Hospital
  • Texas
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study.
2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
3. Subjects who successfully completed Study MT-1186-A01.

Exclusion Criteria:

1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
2. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Visit
3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MT-1186; Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period	Drug: MT-1186; Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.; Other Names: Oral Edaravone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death	AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.; Severe TEAEs: TEAEs which was classified as severe for the severity were analyzed. The severity of TEAEs was classified according to the following criteria: Mild (The event is transient and easily tolerated by the subject.), Moderate: The event causes discomfort and interferes with the subject's general condition.), and Severe (The event causes considerable interference with the subject's general condition and may be incapacitating.); TESAEs, which is Serious TEAEs, is the TEAEs when the patients outcome is death, life-threatening, hospitalization, or disability or permanent damage.	up to 96 Weeks
Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death	AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.	up to 96 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline of ALS Functional Rating Scale-Revised (ALSFRS-R) at Week 96	ALS Functional Rating Scale- Revised (ALSFRS-R). The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities.	Baseline to Week 96
Number of Events of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation		up to 96 Weeks

Collaborators and Investigators

• Sponsor: Tanabe Pharma America, Inc.
• Investigators: Study Director: Head of Medical Science, Tanabe Pharma America, Inc.

Publications and helpful links

General Publications

• Genge A, Pattee GL, Sobue G, Aoki M, Yoshino H, Couratier P, Lunetta C, Petri S, Selness D, Todorovic V, Sasson N, Hirai M, Takahashi F, Salah A, Apple S, Wamil A, Kalin A, Jackson CE. Safety Extension Study of Edaravone Oral Suspension in Patients With Amyotrophic Lateral Sclerosis for up to an Additional 96 Weeks of Treatment. Muscle Nerve. 2025 Sep;72(3):450-454. doi: 10.1002/mus.28451. Epub 2025 Jun 9.

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Actual): August 9, 2023
• Study Completion (Actual): August 9, 2023

Study Registration Dates

• First Submitted: September 30, 2020
• First Submitted That Met QC Criteria: September 30, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Metabolic Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Motor Neuron Disease; Nutritional and Metabolic Diseases; Amyotrophic Lateral Sclerosis; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Pyrazoles; Antipyrine; Pyrazolones; Edaravone
• Other Study ID Numbers: MT-1186-A03; 2020-000376-38 (EudraCT Number); jRCT2041200084 (Registry Identifier: Japan Registry of Clinical Trials (jRCT))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No