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COMPLETED

NCT04165824

PHASE3

Safety Study of Oral Edaravone Administered in Subjects With ALS

Sponsor: Tanabe Pharma America, Inc.

View on ClinicalTrials.gov

Summary

The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

185

Start Date

2019-11-18

Completion Date

2021-10-07

Last Updated

2026-05-08

Healthy Volunteers

Conditions

ALS

Interventions

DRUG

MT-1186

* An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period * Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks.

Inclusion Criteria: * Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed * Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS. * Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed * Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%. * Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent. Exclusion Criteria: * Subjects who have the presence or history of any clinically significant 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. * 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. * Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1). * 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. * Subjects who have ALT or AST elevations greater than 2 times the ULN at screening. * Subjects with a Glomerular Filtration Rate (GFR) \<30 mL/Min Per 1.73 m2. * Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites. * Subjects with hereditary fructose intolerance. * 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. * Subjects who are unable to take their medications orally.

Locations (53)

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

Neuromuscular Research Center

Phoenix, Arizona, United States

Woodland Research Northwest

Rogers, Arkansas, United States

Sutter Health

San Francisco, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

UF Health Cancer Center

Gainesville, Florida, United States

Emory University - School of Medicine

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

University of Michigan - ALS Center of Excellence

Ann Arbor, Michigan, United States

University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location

Northville, Michigan, United States

Essentia Institute of Rural Health

Duluth, Minnesota, United States

Neurology Associates, P.C - Lincoln

Lincoln, Nebraska, United States

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

Winston-Salem, North Carolina, United States

Penn State Hershey Children's Hospital

Hershey, Pennsylvania, United States

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, United States

Alleghany General Hospital

Pittsburgh, Pennsylvania, United States

Wesley Neurology Clinic, P.C.

Cordova, Tennessee, United States

Texas Neurology, PA

Dallas, Texas, United States

Houston Methodist Neurological Institute

Houston, Texas, United States

UT Health Science Center San Antonio

San Antonio, Texas, United States

University of Washington Medical Center

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Heritage Medical Research Clinic - University Of Calgary

Calgary, Alberta, Canada

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

Edmonton, Alberta, Canada

Recherche Sepmus, Inc

Greenfield Park, Quebec, Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

CHU Nice-Hospital Archet I

Nice, Alpes Maritimes, France

Centre Hospitalier Esquirol

Limoges, Marcland, France

Centre Hospitalier Universitaire (CHU) de Bordeaux

Bordeaux, France

Hopital Pierre Wertheimer - Hopital Neurologique

Bron, France

CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques

Nice, France

Deutsche Klinik fuer Diagnostik

Wiesbaden, Hesse, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

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

Milan, MI, Italy

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

Turin, Piedmont, Italy

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

Milan, Italy

Aichi Medical University Hospital

Nagakute-shi, Aichi-ken, Japan

National Hospital Organization Chiba-East-Hospital

Chiba, Chiba, Japan

Murakami Karindoh Hospital

Fukuoka, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

National Hospital Organization Hokkaido Medical Center

Sapporo, Hokkaido, Japan

National Hospital Organization Iou National Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Kita-gun, Kagawa-ken, Japan

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

Yokohama City University Hospital

Yokohama, Kanagawa, Japan

National Hospital Organization Kumamoto Saishun Medical Center

Koshi-shi, Kumamoto, Japan

National Hospital Organization Utano Hospital

Kyoto, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical And Dental Hospital

Niigata, Niigata, Japan

National Hospital Organization Toneyama Medical Center

Toyonaka-shi, Osaka, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Shizuoka, Shizuoka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan