Safety Study of Oral Edaravone Administered in Subjects With ALS

Phase 3

Completed

• Conditions: ALS
• Interventions: Drug: MT-1186

• 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

Study Timeline

• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-13
• Study Start: 2019-11-18
• Study First Posted: 2019-11-18
• Primary Completion: 2021-10-07
• Study Completion: 2021-10-07
• Results First Submitted: 2022-08-05
• Results First Submitted QC: 2022-08-05
• Results First Posted: 2022-08-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-12
• Last Update Posted: 2023-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

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.

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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.

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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

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