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

NCT04577404 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MT-1186-A032020-000376-38jRCT2041200084
• Study Type: interventional
• Target: 124
• Locations: 6 countries
• Sites: 44

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change From Baseline of ALS Functional Rating Scale-Revised (ALSFRS-R) at Week 96

  Baseline to Week 96

• Number of Events of Death, Tracheostomy, or Permanent Assisted Mechanical Ventilation

  up to 96 Weeks

Study Arms (1)

MT-1186

EXPERIMENTAL

Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period

Drug: MT-1186

Interventions

MT-1186 DRUG

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.

Also known as: Oral Edaravone

MT-1186

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
• Subjects who successfully completed Study MT-1186-A01.

You may not qualify if:

• 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.
• 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
• Subjects who are not eligible to continue in the study, as judged by the Investigator.
• Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Sponsors & Collaborators

• Tanabe Pharma America, Inc.: lead

Study Sites (44)

St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center

Phoenix, Arizona, 85013, United States

Location

Neuromuscular Research Center

Phoenix, Arizona, 85028, United States

Location

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

UF Health Cancer Center

Gainesville, Florida, 32610-3633, United States

Location

Emory University - School of Medicine

Atlanta, Georgia, 30317-2819, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21209, United States

Location

Neurology Associates, P.C - Lincoln

Lincoln, Nebraska, 68506, United States

Location

Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation

Winston-Salem, North Carolina, 27157, United States

Location

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, 17025, United States

Location

Alleghany General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Texas Neurology, PA

Dallas, Texas, 75214, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Heritage Medical Research Clinic - University Of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)

Edmonton, Alberta, T6G 2B7, Canada

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

CHU-Nice - Hopital Pasteur 2

Nice, Cedex 1, 06001, France

Location

Centre Hospitalier Esquirol

Limoges, Marcland, 87025, France

Location

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, 33400, France

Location

Hopital Pierre Wertheimer - Hopital Neurologique

Paris, 75013, France

Location

Deutsche Klinik fuer Diagnostik

Wiesbaden, Hesse, 65191, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)

Milan, Lombardy, 20132, Italy

Location

Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)

Turin, Piedmont, 10126, Italy

Location

Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)

Milan, 20162, Italy

Location

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, 480-1195, Japan

Location

National Hospital Organization Chibahigashi National Hospital

Chiba, Chiba, 260-8712, Japan

Location

Murakami Karindoh Hospital

Fukuoka, Fukuoka, 819-8585, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

National Hospital Organization Hokkaido Medical Center

Sapporo, Hokkaido, 063-0005, Japan

Location

National Hospital Organization Iou National Hospital

Kanazawa, Ishikawa-ken, 920-0192, Japan

Location

Kagawa University Hospital

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Kitasato University Hospital

Sagamihara, Kanagawa, 252-0375, Japan

Location

Yokohama City University Hospital

Yokohama, Kanagawa, 236-0004, Japan

Location

National Hospital Organization Kumamoto Saishun Medical Center

Koshi-shi, Kumamoto, 861-1196, Japan

Location

Tohoku University Hospital

Sendai, Miyagi, 980-8574, Japan

Location

Niigata University Medical And Dental Hospital

Niigata, Niigata, 951-8520, Japan

Location

Kansai Electric Power Hospital Recruiting

Fukushima-ku, Osaka-shi, Osaka, 553-0003, Japan

Location

National Hospital Organization Toneyama Medical Center

Toyonaka-shi, Osaka, 560-8552, Japan

Location

Shiga University of Medical Science Hospital

Ōtsu, Shiga, 520-2192, Japan

Location

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, 420-8688, Japan

Location

Juntendo University Hospital

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokyo Metropolitan Neurological Hospital

Fuchū, Tokyo, 183-0042, Japan

Location

Toho University Omori Medical Center

Ōta-ku, Tokyo, 143-8541, Japan

Location

Related Publications (1)

• 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.

  PMID: 40485494 RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Edaravone

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Antipyrine; Pyrazolones; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma America, Inc.

information.US@mb.tanabe-pharma.com

908-607-1980

Study Officials

• Head of Medical Science

  Tanabe Pharma America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Arm Open Label

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 6, 2020
• Study Start: October 29, 2020
• Primary Completion: August 9, 2023
• Study Completion: August 9, 2023
• Last Updated: December 30, 2025
• Results First Posted: August 28, 2024

Record last verified: 2025-12

Locations

CA (3); IT (3); JP (19); US (13); DE (2); FR (4)