A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Study Purpose:

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:

Study Status:




Study Type:


Type of Intervention:


Intervention Name:

MT-1186, Placebo




Phase 3

Study Chair(s)/Principal Investigator(s):

Head of Medical Science, Mitsubishi Tanabe Pharma Development America, Inc.

Clinicaltrials.gov ID:


Neals Affiliated?


Coordinating Center Contact Information

Mitsubishi Tanabe Pharma Development America, Inc.

Clinical Trials Information Desk,For North America (USA English, USA Spanish, and Canadian French) / email hidden; JavaScript is required / +1-800-313-9381

United States

Full Study Summary:


- North America (USA English, USA Spanish, and Canadian French) +1-800-313-9381; mailbox address is MT1186@iconplc.com

- Japan: 0120-330-800 (Japan only)

Study Sponsor:

Mitsubishi Tanabe Pharma Development America, Inc.

Estimated Enrollment:


Estimated Study Start Date:

11 / 13 / 2020

Estimated Study Completion Date:

07 / 01 / 2023

Posting Last Modified Date:

05 / 24 / 2022

Date Study Added to neals.org:

09 / 29 / 2020

Minimum Age:

18 Years

Maximum Age:

75 Years

Can participants use Riluzole?


Inclusion Criteria:

1. Subjects must provide a 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.

2. Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed.

3. Subjects will be diagnosed with Definite ALS or Probable ALS according to the El Escorial revised criteria for the diagnosis of ALS.

4. Subjects with a baseline score ≥ 2 points on each individual item of the ALSFRS- R at screening and baseline visits.

5. Subjects have a screening and baseline %forced vital capacity (FVC) ≥ 70%.

6. Subjects with 1- to 4-point decline for 8 weeks (±7 days) in ALSFRS-R total score between screening and baseline visits.

7. Subjects whose first symptom of ALS has occurred within 2 years of providing written informed consent.

Exclusion Criteria:

Exclusions Related to Primary Diagnosis

1. Subjects with a history of spinal surgery after the onset of ALS, such as surgery for cervical spondylosis or a herniated disc, or plans for such surgery during the study period.

Exclusions Related to Other Neurological Disorders (including, but not limited to the following)

2. Subjects with the possibility that the current symptoms may be symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy, cannot be ruled out.

Exclusions Related to General Health or Concomitant Conditions

3. Subjects undergoing treatment for a malignancy.

4. Subjects with a complication that could have a significant effect on efficacy evaluations, such as Parkinson's disease or syndrome, schizophrenia, bipolar disorder, and dementia.

5. Subjects who have the presence or history of any clinically significant (CS) disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.

6. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).

7. Subjects of childbearing potential unwilling to use acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period.

8. Subjects who have a significant risk of suicidality. 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 Columbia-Suicide Severity Rating Scale (C-SSRS) within the 3 months before the screening visit.

9. Subjects who have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevations greater than 2 times the upper limit of normal (ULN) at screening.

10. Subjects with a Glomerular Filtration Rate (GFR) < 30 mL/Min Per 1.73 m2 at screening, using the Larsson Equation.

Exclusions Related to Medications

11. Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.

12. Subjects with hereditary problems of fructose intolerance (eg, fructose, sucrose, invert sugar, and sorbitol).

13. Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer, before providing informed consent for the present study.

14. Subjects who have received any previous treatment with edaravone.

15. Subjects who have received stem cell therapy.

16. Subjects who are unable to take their medications orally at baseline (Visit 2).

HonorHealth Neurology | Recruiting

Scottsdale, Arizona 85251
United States

St. Joseph's Hospital and Medical Center (SJHMC) | Recruiting

Phoenix, Arizona 85013
United States

Woodland Research Northwest | Recruiting

Rogers, Arkansas 72758
United States

UCSD Medical Center | Recruiting

La Jolla, California 92037-0897
United States

Loma Linda University Health Care - Department of Neurology | Recruiting

Loma Linda, California 92354
United States

University California Los Angeles Medical Center (UCLA) | Recruiting

Los Angeles, California 90095
United States

University of California Irvine (UCI) Health - Women's Healthcare Center | Recruiting

Orange, California 92868
United States

University of Colorado Anschutz Medical Campus | Recruiting

Aurora, Colorado 80045
United States

University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC) | Recruiting

Tampa, Florida 33616
United States

UF Health Cancer Center | Recruiting

Gainesville, Florida 32610-3633
United States

Mayo Clinic | Recruiting

Jacksonville, Florida 32224
United States

Emory University - School of Medicine | Recruiting

Atlanta, Georgia 30322
United States

Northwestern University Feinberg School of Medicine | Recruiting

Chicago, Illinois 60611-2605
United States

Ochsner Center for Primary Care and Wellness | Recruiting

Jefferson, Louisiana 70121
United States

Johns Hopkins University | Recruiting

Baltimore, Maryland 21205
United States

Lahey Hospital | Recruiting

Burlington, Massachusetts 01805
United States

Mayo Clinic | Recruiting

Rochester, Minnesota 55905
United States

Neurology Associates, P.C. - Lincoln | Recruiting

Lincoln, Nebraska 68506-2960
United States

Las Vegas Clinic | Recruiting

Las Vegas, Nevada 89145
United States

Dent Neurologic Institute | Recruiting

Amherst, New York 14226
United States

SUNY Upstate Medical University | Recruiting

Syracuse, New York 13210
United States

Penn State Hershey Medical Center | Recruiting

Hershey, Pennsylvania 17033
United States

Thomas Jefferson University, Jefferson Weinberg ALS Center | Recruiting

Philadelphia, Pennsylvania 19107
United States

Lewis Katz School of Medicine at Temple University | Recruiting

Philadelphia, Pennsylvania 19140
United States

University Of Pittsburgh Medical Center | Recruiting

Pittsburgh, Pennsylvania 15261
United States

Wesley Neurology Clinic, P.C. | Recruiting

Cordova, Tennessee 38018
United States

Austin Neuromuscular Center | Recruiting

Austin, Texas 78756
United States

Nerve And Muscle Center Of Texas | Active, not recruiting

Houston, Texas 77019
United States

The University of Vermont (UVM) and UVM Medical Center National ALS Center of Excellence | Recruiting

Burlington, Vermont 05401-3456
United States

Sentara Neurology Specialists | Recruiting

Virginia Beach, Virginia 23456
United States

University of Washington Medical Center | Recruiting

Seattle, Washington 98195
United States

St. Luke's Rehabilitation Institute | Recruiting

Spokane, Washington 99202
United States

West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic | Recruiting

Morgantown, West Virginia 26506-9180
United States

Medical College of Wisconsin | Recruiting

Milwaukee, Wisconsin 53226
United States

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

Edmonton, Alberta T6G 2B7

Health Science Center Mcmaster University | Recruiting

Hamilton, Ontario L8P 1H1

London Health Sciences Centre - University Hospital | Recruiting

London, Ontario N6A 5A5

Odette Cancer Center-Sunnybrook Health Sciences Centre | Recruiting

Toronto, Ontario M4N 3M5

Recherche Sepmus, Inc | Recruiting

Greenfield Park, Quebec J4V 2J2

Centre Hospitalier De L'Universite De Montreal (Chum) Notre-Dame Hospital | Recruiting

Montreal, Quebec H2L 4M1

Montreal Neurological Institute And Hospital | Recruiting

Montreal, Quebec H3A 2B4

CHU de Quebec-Hopital-Enfant-Jesus | Recruiting

Quebec City, Quebec G1J 1Z4

Saskatoon City Hospital | Recruiting

Saskatoon, Saskatchewan S7K 0M7

Regional Health Authority B | Recruiting

Fredericton, New Brunswick E3B 0C7

Klinikum Rechts der Isar der Technischen Universitaet Muenchen | Recruiting

Muenchen 81675

Deutsche Klinik fuer Diagnostik | Recruiting

Wiesbaden 65191

Universitaets- und Rehabilitationskliniken Ulm | Recruiting

Ulm 89081

University Medical Center Rostock | Recruiting

Rostock 18147

Universitaetsklinikum Wuerzburg | Recruiting

Wuezburg 97080

Universitaetsklinikum Jena | Recruiting

Jena 86899

Universitätsklinik Bonn-Motoneuronambulanz, Klinik und Poliklinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie | Recruiting

Bonn 53127

Charite Campus Virchow | Recruiting

Berlin 13353

UKRUB - Berufsgenossenschaftliches Universitatsklinikum Bergmannsheil GmbH - Medizinische Klinik III | Recruiting

Bochum, Nordrhein-Westfalen 44789

Medizinische Hochschule Hannover | Recruiting

Hannover, Lower Saxony 30625

Georg-August-Universitaet Goettingen - Universitaetsmedizin Goettingen (UMG) | Recruiting

Goettingen 37075

Istituto Auxologico Italiano - Istituto Di Ricovero e Cura a Carattere Scientifico - Istituto Scientifico Ospedale San Luca | Recruiting

Modena 41126

Centro SLA di Palermo | Recruiting

Palermo 90129

Policlinico A. Gemelli | Recruiting

Roma CAP 00168

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

Milan Italy

Istituto Nazionale Neurologico Carlo Besta | Recruiting

Milano Italy

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

Milano 20132

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

Turin, Piemonte 10126

Chiba University Hospital | Recruiting

Chiba 260-8677

Keio University Hospital | Completed

Shinjuku-ku, Tokyo 160-8582

Niigata University Medical & Dental Hospital | Recruiting

Asahimachidori, Chuo-ku, Niigata-shi, Niigata 951-8520

Toho University Omori Medical Center | Recruiting

Ota-ku, Tokyo 143-8541

Teikyo University Hospital | Recruiting

Itabashi-ku, Tokyo 173-8606

Tokyo Metropolitan Neurological Hospital | Recruiting

Fuchu-city, Tokyo 183-0042

Juntendo University Hospital | Recruiting

Bunkyo-ku, Tokyo 113-8431

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders | Recruiting

Aoi-ku, Shizuoka-shi, Shizuoka 420-8688

Shiga University of Medical Science Hospital | Recruiting

Otsu City, Shiga 520-2192

Saitama Neuropsychiatric Institute | Recruiting

Chuo-ku, Saitama-shi, Saitama 338-8577

National Hospital Organization Osaka Toneyama Medical Center | Recruiting

Toyonaka-shi, Osaka 560-8552

Kansai Electric Power Hospital | Recruiting

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

National Hospital Organization Chibahigashi National Hospital | Recruiting

Chuo-ku, Chiba-shi, Chiba 260-8712

Tohoku University Hospital | Recruiting

Sendai-city, Miyagi 980-8574

Hiroshima University Hospital | Recruiting

Minami-ku, Hiroshima-shi, Hiroshima 734-8551

National Hospital Organization Higashinagoya National Hospital | Recruiting

Meito-ku, Nagoya-shi, Aichi 465-8620

Nagoya University Hospital | Recruiting

Showa-ku, Nagoya, Aichi 466-8560

National Hospital Organization Utano National Hospital | Recruiting

Ukyo-ku, Kyoto City, Kyoto 616-8255

Fukushima Medical University Hospital | Recruiting

Fukushima-shi, Fukushima 960-1295

Murakami Karindoh Hospital | Recruiting

Nishi-ku, Fukuoka-shi, Fukuoka 819-8585

National Hospital Organization Hokkaido Medical Center | Recruiting

Sapporo-shi, Hokkaido 063-0005

National Hospital Organization Iou National Hospital | Recruiting

Kanazawa-shi, Ishikawa 920-0192

Kagawa University Hospital | Recruiting

Miki-cho, Kita-gun, Kagawa 761-0793

Yokohama City University Hospital | Recruiting

Kanazawa-ku, Yokohama-shi, Kanagawa 236-0004

Kitasato University Hospital | Recruiting

Minami-ku, Sagamihara-city, Kanagawa 252-0375

National Hospital Organization Kumamoto Saishun Medical Center | Recruiting

Koshi-shi, Kumamoto 861-1196

Seoul National University Hospital | Recruiting

Seoul 03080
Korea, Republic of

Hanyang University Medical Center | Recruiting

Seoul 04763
Korea, Republic of

Samsung Medical Center | Recruiting

Seoul 06351
Korea, Republic of

University hospital Bern (Inselspital) | Recruiting

Bern, BE 3010

Hopitaux Universitaires de Geneve (HUG) (Hopital Cantonal) | Recruiting

Geneve 1205

Neurocenter of Southern Switzerland | Recruiting

Lugano 6903

Zentrumsleiter Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic | Recruiting

St.Gallen 9107