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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04569084
Other study ID # MT-1186-A02
Secondary ID jRCT203120030120
Status Terminated
Phase Phase 3
First received
Last updated
Start date November 13, 2020
Est. completion date September 29, 2023

Study information

Verified date October 2023
Source Mitsubishi Tanabe Pharma America Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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:


Recruitment information / eligibility

Status Terminated
Enrollment 384
Est. completion date September 29, 2023
Est. primary completion date September 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MT-1186
Oral edaravone
Placebo
Oral

Locations

Country Name City State
Canada University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM) Edmonton Alberta
Canada Regional Health Authority B Fredericton New Brunswick
Canada Recherche Sepmus, Inc Greenfield Park Quebec
Canada Health Science Center Mcmaster University Hamilton Ontario
Canada London Health Sciences Centre - University Hospital London Ontario
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 Quebec City Quebec
Canada Saskatoon City Hospital Saskatoon Saskatchewan
Canada Odette Cancer Center-Sunnybrook Health Sciences Centre Toronto Ontario
Germany Charite Campus Virchow Berlin
Germany UKRUB - Berufsgenossenschaftliches Universitatsklinikum Bergmannsheil GmbH - Medizinische Klinik III Bochum Nordrhein-Westfalen
Germany Universitätsklinik Bonn-Motoneuronambulanz, Klinik und Poliklinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie Bonn
Germany Georg-August-Universitaet Goettingen - Universitaetsmedizin Goettingen (UMG) Goettingen
Germany Medizinische Hochschule Hannover Hannover Lower Saxony
Germany Universitaetsklinikum Jena Jena
Germany Klinikum Rechts der Isar der Technischen Universitaet Muenchen Muenchen
Germany University Medical Center Rostock Rostock
Germany Universitaets- und Rehabilitationskliniken Ulm Ulm
Germany Deutsche Klinik fuer Diagnostik Wiesbaden
Germany Universitaetsklinikum Wuerzburg Wuezburg
Italy Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre) Milan
Italy Istituto Nazionale Neurologico Carlo Besta Milano
Italy Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) Milano
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 Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA) Turin Piemonte
Japan National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders Aoi-ku, Shizuoka-shi Shizuoka
Japan Niigata University Medical & Dental Hospital Asahimachidori, Chuo-ku, Niigata-shi Niigata
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan Chiba University Hospital Chiba
Japan National Hospital Organization Chibahigashi National Hospital Chuo-ku, Chiba-shi Chiba
Japan Saitama Neuropsychiatric Institute Chuo-ku, Saitama-shi Saitama
Japan Tokyo Metropolitan Neurological Hospital Fuchu-city Tokyo
Japan Kansai Electric Power Hospital Fukushima-ku, Osaka-shi Osaka
Japan Fukushima Medical University Hospital Fukushima-shi Fukushima
Japan Teikyo University Hospital Itabashi-ku Tokyo
Japan Yokohama City University Hospital Kanazawa-ku, Yokohama-shi Kanagawa
Japan National Hospital Organization Iou National Hospital Kanazawa-shi Ishikawa
Japan National Hospital Organization Kumamoto Saishun Medical Center Koshi-shi Kumamoto
Japan National Hospital Organization Higashinagoya National Hospital Meito-ku, Nagoya-shi Aichi
Japan Kagawa University Hospital Miki-cho, Kita-gun Kagawa
Japan Hiroshima University Hospital Minami-ku, Hiroshima-shi Hiroshima
Japan Kitasato University Hospital Minami-ku, Sagamihara-city Kanagawa
Japan Murakami Karindoh Hospital Nishi-ku, Fukuoka-shi Fukuoka
Japan Toho University Omori Medical Center Ota-ku Tokyo
Japan Shiga University of Medical Science Hospital Otsu City Shiga
Japan National Hospital Organization Hokkaido Medical Center Sapporo-shi Hokkaido
Japan Tohoku University Hospital Sendai-city Miyagi
Japan Keio University Hospital Shinjuku-ku Tokyo
Japan Nagoya University Hospital Showa-ku, Nagoya Aichi
Japan National Hospital Organization Osaka Toneyama Medical Center Toyonaka-shi Osaka
Japan National Hospital Organization Utano National Hospital Ukyo-ku, Kyoto City Kyoto
Korea, Republic of Hanyang University Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul
Switzerland University hospital Bern (Inselspital) Bern BE
Switzerland Hopitaux Universitaires de Geneve (HUG) (Hopital Cantonal) Geneve
Switzerland Neurocenter of Southern Switzerland Lugano
Switzerland Zentrumsleiter Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic St.Gallen
United States Dent Neurologic Institute Amherst New York
United States Emory University - School of Medicine Atlanta Georgia
United States University of Colorado Anschutz Medical Campus Aurora Colorado
United States Austin Neuromuscular Center Austin Texas
United States Johns Hopkins University Baltimore Maryland
United States Lahey Hospital Burlington Massachusetts
United States The University of Vermont (UVM) and UVM Medical Center National ALS Center of Excellence Burlington Vermont
United States Northwestern University Feinberg School of Medicine Chicago Illinois
United States Wesley Neurology Clinic, P.C. Cordova Tennessee
United States UF Health Cancer Center Gainesville Florida
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Nerve And Muscle Center Of Texas Houston Texas
United States Mayo Clinic Jacksonville Florida
United States Ochsner Center for Primary Care and Wellness Jefferson Louisiana
United States UCSD Medical Center La Jolla California
United States Las Vegas Clinic Las Vegas Nevada
United States Neurology Associates, P.C. - Lincoln Lincoln Nebraska
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 Medical College of Wisconsin Milwaukee Wisconsin
United States West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic Morgantown West Virginia
United States University of California Irvine (UCI) Health - Women's Healthcare Center Orange California
United States Lewis Katz School of Medicine at Temple University Philadelphia Pennsylvania
United States Thomas Jefferson University, Jefferson Weinberg ALS Center Philadelphia Pennsylvania
United States St. Joseph's Hospital and Medical Center (SJHMC) Phoenix Arizona
United States University Of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Mayo Clinic Rochester Minnesota
United States Woodland Research Northwest Rogers Arkansas
United States HonorHealth Neurology Scottsdale Arizona
United States University of Washington Medical Center Seattle Washington
United States St. Luke's Rehabilitation Institute Spokane Washington
United States SUNY Upstate Medical University Syracuse New York
United States University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC) Tampa Florida
United States Sentara Neurology Specialists Virginia Beach Virginia

Sponsors (1)

Lead Sponsor Collaborator
Mitsubishi Tanabe Pharma America Inc.

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Italy,  Japan,  Korea, Republic of,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Other Time to death, tracheostomy or permanent assisted mechanical ventilation (= 23 hours/day) up to 48 Weeks
Primary Change in ALS Functional Rating Scale- Revised (ALSFRS-R) score from baseline to Week 48 of treatment The ALSFRS-R is rating scale (ratings 0 = can't do, to 4 = normal ability) used to determine participants' assessment of their capability and independence in 12 functional activities. up to 48 Weeks
Secondary Change from baseline in % slow vital capacity (SVC) at Week 48 up to 48 Weeks
Secondary Change from baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire (ALSAQ)40 at Week 48 The ALSAQ-40 is a questionnaire that consists of 40 questions/items with 5 discrete scales: physical mobility, activities of daily living and independence, eating and drinking, communication, emotional reactions, ranging from 0 (best health as assessed by the scale) to 100 (worse health as assessed by the measure). up to 48 Weeks
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