Safety Study of Oral Edaravone Administered in Subjects With ALS
- Registration Number
- NCT04165824
- Lead Sponsor
- Mitsubishi Tanabe Pharma America Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MT-1186 MT-1186 -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergency Adverse Events Up to 48 Weeks Number of Treatment Emergency Adverse Events up to 48 Weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Neurology Associates, P.C - Lincoln
🇺🇸Lincoln, Nebraska, United States
Texas Neurology, PA
🇺🇸Dallas, Texas, United States
Lewis Katz School of Medicine at Temple University
🇺🇸Philadelphia, Pennsylvania, United States
Alleghany General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Houston Methodist Neurological Institute
🇺🇸Houston, Texas, United States
Essentia Institute of Rural Health
🇺🇸Duluth, Minnesota, United States
Penn State Hershey Children's Hospital
🇺🇸Hershey, Pennsylvania, United States
National Hospital Organization Chiba-East-Hospital
🇯🇵Chiba-shi, Chiba, Japan
National Hospital Organization Iou National Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Juntendo University Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Niigata University Medical And Dental Hospital
🇯🇵Niigata-shi, Niigata, Japan
Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation
🇺🇸Winston-Salem, North Carolina, United States
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
UF Health Cancer Center
🇺🇸Gainesville, Florida, United States
University of Michigan Health System (UMHS) - Allergy Clinic - Northville Health Center Location
🇺🇸Northville, Michigan, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Wesley Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, 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
Montreal Neurological Institute and Hospital
🇨🇦Montreal, Quebec, Canada
CHU Nice-Hospital Archet I
🇫🇷Nice cedex 3, Alpes Maritimes, France
Recherche Sepmus, Inc
🇨🇦Greenfield Park, Quebec, Canada
Centre Hospitalier Esquirol
🇫🇷Limoges, Marcland, France
Deutsche Klinik fuer Diagnostik
🇩🇪Wiesbaden, Hessen, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Lower Saxony, Germany
Hopital Pierre Wertheimer - Hopital Neurologique
🇫🇷Bron, France
Centre Hospitalier Universitaire (CHU) de Bordeaux
🇫🇷Bordeaux, France
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
🇮🇹Milano, MI, Italy
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
🇮🇹Milan, Italy
Aichi Medical University Hospital
🇯🇵Nagakute-shi, Aichi, Japan
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
🇮🇹Turin, Piemonte, Italy
Murakami Karindoh Hospital
🇯🇵Fukuoka-city, Fukuoka, Japan
Kagawa University Hospital
🇯🇵Kita-gun, Kagawa, Japan
National Hospital Organization Hokkaido Medical Center
🇯🇵Sapporo-shi, Hokkaido, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima-shi, Fukushima, Japan
Kitasato University Hospital
🇯🇵Sagamihara-city, Kanagawa, Japan
National Hospital Organization Kumamoto Saishun Medical Center
🇯🇵Koshi-shi, Kumamoto, Japan
National Hospital Organization Utano Hospital
🇯🇵Kyoto-shi, Kyoto, Japan
Yokohama City University Hospital
🇯🇵Yokohama-shi, Kanagawa, Japan
National Hospital Organization Toneyama Medical Center
🇯🇵Toyonaka-shi, Osaka, Japan
Shiga University of Medical Science Hospital
🇯🇵Otsu-shi, Shiga, Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
🇯🇵Shizuoka-city, Shizuoka, Japan
Sutter Health
🇺🇸San Francisco, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Emory University - School of Medicine
🇺🇸Atlanta, Georgia, United States
University of Michigan - ALS Center of Excellence
🇺🇸Ann Arbor, Michigan, United States
UT Health Science Center San Antonio
🇺🇸San Antonio, Texas, United States
CHU de NICE Hopital Pasteur 2 -Centre de Reference des Maladies -Neuromusculaires & SLA-Pole Neurosciences Cliniques
🇫🇷Nice cedex 1, France
Tohoku University Hospital
🇯🇵Sendai-city, Miyagi, Japan