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NCT04569084

PHASE3

Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS

Sponsor: Shionogi

View on ClinicalTrials.gov

Summary

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:

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

384

Start Date

2020-11-13

Completion Date

2023-09-29

Last Updated

2026-07-20

Healthy Volunteers

Conditions

ALS

Interventions

DRUG

MT-1186

Oral edaravone

DRUG

Placebo

Oral

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).

Locations (95)

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

Phoenix, Arizona, United States

HonorHealth Neurology

Scottsdale, Arizona, United States

Woodland Research Northwest

Rogers, Arkansas, United States

UCSD Medical Center

La Jolla, California, United States

Loma Linda University Health Care - Department of Neurology

Loma Linda, California, United States

University California Los Angeles Medical Center (UCLA)

Los Angeles, California, United States

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

Orange, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

UF Health Cancer Center

Gainesville, Florida, United States

Mayo Clinic

Jacksonville, Florida, United States

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

Tampa, Florida, United States

Emory University - School of Medicine

Atlanta, Georgia, United States

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Ochsner Center for Primary Care and Wellness

Jefferson, Louisiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Lahey Hospital

Burlington, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Neurology Associates, P.C. - Lincoln

Lincoln, Nebraska, United States

Las Vegas Clinic

Las Vegas, Nevada, United States

Dent Neurologic Institute

Amherst, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University, Jefferson Weinberg ALS Center

Philadelphia, Pennsylvania, United States

Lewis Katz School of Medicine at Temple University

Philadelphia, Pennsylvania, United States

University Of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Wesley Neurology Clinic, P.C.

Cordova, Tennessee, United States

Austin Neuromuscular Center

Austin, Texas, United States

Nerve And Muscle Center Of Texas

Houston, Texas, United States

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

Burlington, Vermont, United States

Sentara Neurology Specialists

Virginia Beach, Virginia, United States

University of Washington Medical Center

Seattle, Washington, United States

St. Luke's Rehabilitation Institute

Spokane, Washington, United States

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

Morgantown, West Virginia, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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

Edmonton, Alberta, Canada

Regional Health Authority B

Fredericton, New Brunswick, Canada

Health Science Center Mcmaster University

Hamilton, Ontario, Canada

London Health Sciences Centre - University Hospital

London, Ontario, Canada

Odette Cancer Center-Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Recherche Sepmus, Inc

Greenfield Park, Quebec, Canada

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

Montreal, Quebec, Canada

Montreal Neurological Institute And Hospital

Montreal, Quebec, Canada

CHU de Quebec-Hopital-Enfant-Jesus

Québec, Quebec, Canada

Saskatoon City Hospital

Saskatoon, Saskatchewan, Canada

Universitaetsklinikum Wuerzburg

Wuezburg, Germany, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

UKRUB - Berufsgenossenschaftliches Universitatsklinikum Bergmannsheil GmbH - Medizinische Klinik III

Bochum, North Rhine-Westphalia, Germany

Charite Campus Virchow

Berlin, Germany

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

Bonn, Germany

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

Göttingen, Germany

Universitaetsklinikum Jena

Jena, Germany

Klinikum Rechts der Isar der Technischen Universitaet Muenchen

München, Germany

University Medical Center Rostock

Rostock, Germany

Universitaets- und Rehabilitationskliniken Ulm

Ulm, Germany

Deutsche Klinik fuer Diagnostik

Wiesbaden, Germany

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

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

Milan, Italy

Istituto Nazionale Neurologico Carlo Besta

Milan, Italy

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

Modena, Italy

Centro SLA di Palermo

Palermo, Italy

Policlinico A. Gemelli

Roma, Italy

National Hospital Organization Higashinagoya National Hospital

Meito-ku, Nagoya-shi, Aichi-ken, Japan

Nagoya University Hospital

Showa-ku, Nagoya, Aichi-ken, Japan

National Hospital Organization Chibahigashi National Hospital

Chuo-ku, Chiba-shi, Chiba, Japan

Murakami Karindoh Hospital

Nishi-ku, Fukuoka-shi, Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan

Hiroshima University Hospital

Minami-ku, Hiroshima-shi, Hiroshima, Japan

National Hospital Organization Hokkaido Medical Center

Sapporo, Hokkaido, Japan

National Hospital Organization Iou National Hospital

Kanazawa, Ishikawa-ken, Japan

Kagawa University Hospital

Miki-cho, Kita-gun, Kagawa-ken, Japan

Yokohama City University Hospital

Kanazawa-ku, Yokohama-shi, Kanagawa, Japan

Kitasato University Hospital

Minami-ku, Sagamihara-city, Kanagawa, Japan

National Hospital Organization Kumamoto Saishun Medical Center

Koshi-shi, Kumamoto, Japan

National Hospital Organization Utano National Hospital

Ukyo-ku, Kyoto City, Kyoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Niigata University Medical & Dental Hospital

Asahimachidori, Chuo-ku, Niigata-shi, Niigata, Japan

Kansai Electric Power Hospital

Fukushima-ku, Osaka-shi, Osaka, Japan

National Hospital Organization Osaka Toneyama Medical Center

Toyonaka-shi, Osaka, Japan

Saitama Neuropsychiatric Institute

Chuo-ku, Saitama-shi, Saitama, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders

Aoi-ku, Shizuoka-shi, Shizuoka, Japan

Juntendo University Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Metropolitan Neurological Hospital

Fuchū, Tokyo, Japan

Teikyo University Hospital

Itabashi-ku, Tokyo, Japan

Toho University Omori Medical Center

Ōta-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Chiba University Hospital

Chiba, Japan

Seoul National University Hospital

Seoul, South Korea

Hanyang University Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

University hospital Bern (Inselspital)

Bern, Canton of Bern, Switzerland

Hopitaux Universitaires de Geneve (HUG) (Hopital Cantonal)

Geneva, Switzerland

Neurocenter of Southern Switzerland

Lugano, Switzerland

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

Sankt Gallen, Switzerland

Clinical Research Directory

Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (95)