Study Purpose:
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:Study Status:
Not recruiting
Disease:
ALS
Study Type:
Interventional
Type of Intervention:
Drug
Intervention Name:
MT-1186, Placebo
Placebo:
Yes
Phase:
Phase 3
Study Chair(s)/Principal Investigator(s):
Head of Medical Science, Mitsubishi Tanabe Pharma America Inc.
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Mitsubishi Tanabe Pharma Development America, Inc.
United States
Full Study Summary:
Contacts:
- North America (USA English, USA Spanish, and Canadian French) +1-800-313-9381; mailbox address is MT1186@iconplc.com
- Japan: 0120-330-800 (Japan only)
- North America (USA English, USA Spanish, and Canadian French) +1-800-313-9381; mailbox address is MT1186@iconplc.com
- Japan: 0120-330-800 (Japan only)
Study Sponsor:
Mitsubishi Tanabe Pharma America Inc.
Estimated Enrollment:
380
Estimated Study Start Date:
11 / 13 / 2020
Estimated Study Completion Date:
07 / 01 / 2023
Posting Last Modified Date:
05 / 15 / 2023
Date Study Added to neals.org:
09 / 29 / 2020
Minimum Age:
18 Years
Maximum Age:
75 Years
Can participants use Riluzole?
Yes
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).
HonorHealth Neurology
Scottsdale, Arizona
85251
United States
St. Joseph's Hospital and Medical Center (SJHMC)
Phoenix, Arizona
85013
United States
Woodland Research Northwest
Rogers, Arkansas
72758
United States
UCSD Medical Center
La Jolla, California
92037-0897
United States
Loma Linda University Health Care - Department of Neurology
Loma Linda, California
92354
United States
University California Los Angeles Medical Center (UCLA)
Los Angeles, California
90095
United States
University of California Irvine (UCI) Health - Women's Healthcare Center
Orange, California
92868
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado
80045
United States
University of South Florida (USF) - Carol and Frank Morsani Center for Advanced Health Care (CAHC)
Tampa, Florida
33616
United States
UF Health Cancer Center
Gainesville, Florida
32610-3633
United States
Mayo Clinic
Jacksonville, Florida
32224
United States
Emory University - School of Medicine
Atlanta, Georgia
30322
United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois
60611-2605
United States
Ochsner Center for Primary Care and Wellness
Jefferson, Louisiana
70121
United States
Johns Hopkins University
Baltimore, Maryland
21205
United States
Lahey Hospital
Burlington, Massachusetts
01805
United States
Mayo Clinic
Rochester, Minnesota
55905
United States
Neurology Associates, P.C. - Lincoln
Lincoln, Nebraska
68506-2960
United States
Las Vegas Clinic
Las Vegas, Nevada
89145
United States
Dent Neurologic Institute
Amherst, New York
14226
United States
SUNY Upstate Medical University
Syracuse, New York
13210
United States
Penn State Hershey Medical Center
Hershey, Pennsylvania
17033
United States
Thomas Jefferson University, Jefferson Weinberg ALS Center
Philadelphia, Pennsylvania
19107
United States
Lewis Katz School of Medicine at Temple University
Philadelphia, Pennsylvania
19140
United States
University Of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
15261
United States
Wesley Neurology Clinic, P.C.
Cordova, Tennessee
38018
United States
Austin Neuromuscular Center
Austin, Texas
78756
United States
Nerve And Muscle Center Of Texas
Houston, Texas
77019
United States
The University of Vermont (UVM) and UVM Medical Center National ALS Center of Excellence
Burlington, Vermont
05401-3456
United States
Sentara Neurology Specialists
Virginia Beach, Virginia
23456
United States
University of Washington Medical Center
Seattle, Washington
98195
United States
St. Luke's Rehabilitation Institute
Spokane, Washington
99202
United States
West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic
Morgantown, West Virginia
26506-9180
United States
Medical College of Wisconsin
Milwaukee, Wisconsin
53226
United States
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)
Edmonton, Alberta
T6G 2B7
Canada
Health Science Center Mcmaster University
Hamilton, Ontario
L8P 1H1
Canada
London Health Sciences Centre - University Hospital
London, Ontario
N6A 5A5
Canada
Odette Cancer Center-Sunnybrook Health Sciences Centre
Toronto, Ontario
M4N 3M5
Canada
Recherche Sepmus, Inc
Greenfield Park, Quebec
J4V 2J2
Canada
Centre Hospitalier De L'Universite De Montreal (Chum) Notre-Dame Hospital
Montreal, Quebec
H2L 4M1
Canada
Montreal Neurological Institute And Hospital
Montreal, Quebec
H3A 2B4
Canada
CHU de Quebec-Hopital-Enfant-Jesus
Quebec City, Quebec
G1J 1Z4
Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan
S7K 0M7
Canada
Regional Health Authority B
Fredericton, New Brunswick
E3B 0C7
Canada
Klinikum Rechts der Isar der Technischen Universitaet Muenchen
Muenchen 81675
Germany
Deutsche Klinik fuer Diagnostik
Wiesbaden 65191
Germany
Universitaets- und Rehabilitationskliniken Ulm
Ulm 89081
Germany
University Medical Center Rostock
Rostock 18147
Germany
Universitaetsklinikum Wuerzburg
Wuezburg 97080
Germany
Universitaetsklinikum Jena
Jena 86899
Germany
Universitätsklinik Bonn-Motoneuronambulanz, Klinik und Poliklinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie
Bonn 53127
Germany
Charite Campus Virchow
Berlin 13353
Germany
UKRUB - Berufsgenossenschaftliches Universitatsklinikum Bergmannsheil GmbH - Medizinische Klinik III
Bochum, Nordrhein-Westfalen
44789
Germany
Medizinische Hochschule Hannover
Hannover, Lower Saxony
30625
Germany
Georg-August-Universitaet Goettingen - Universitaetsmedizin Goettingen (UMG)
Goettingen 37075
Germany
Istituto Auxologico Italiano - Istituto Di Ricovero e Cura a Carattere Scientifico - Istituto Scientifico Ospedale San Luca
Modena 41126
Italy
Centro SLA di Palermo
Palermo 90129
Italy
Policlinico A. Gemelli
Roma CAP 00168
Italy
Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)
Milan Italy
Italy
Istituto Nazionale Neurologico Carlo Besta
Milano Italy
Italy
Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)
Milano 20132
Italy
Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)
Turin, Piemonte
10126
Italy
Chiba University Hospital
Chiba 260-8677
Japan
Keio University Hospital
Shinjuku-ku, Tokyo
160-8582
Japan
Niigata University Medical & Dental Hospital
Asahimachidori, Chuo-ku, Niigata-shi, Niigata
951-8520
Japan
Toho University Omori Medical Center
Ota-ku, Tokyo
143-8541
Japan
Teikyo University Hospital
Itabashi-ku, Tokyo
173-8606
Japan
Tokyo Metropolitan Neurological Hospital
Fuchu-city, Tokyo
183-0042
Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo
113-8431
Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders
Aoi-ku, Shizuoka-shi, Shizuoka
420-8688
Japan
Shiga University of Medical Science Hospital
Otsu City, Shiga
520-2192
Japan
Saitama Neuropsychiatric Institute
Chuo-ku, Saitama-shi, Saitama
338-8577
Japan
National Hospital Organization Osaka Toneyama Medical Center
Toyonaka-shi, Osaka
560-8552
Japan
Kansai Electric Power Hospital
Fukushima-ku, Osaka-shi, Osaka
553-0003
Japan
National Hospital Organization Chibahigashi National Hospital
Chuo-ku, Chiba-shi, Chiba
260-8712
Japan
Tohoku University Hospital
Sendai-city, Miyagi
980-8574
Japan
Hiroshima University Hospital
Minami-ku, Hiroshima-shi, Hiroshima
734-8551
Japan
National Hospital Organization Higashinagoya National Hospital
Meito-ku, Nagoya-shi, Aichi
465-8620
Japan
Nagoya University Hospital
Showa-ku, Nagoya, Aichi
466-8560
Japan
National Hospital Organization Utano National Hospital
Ukyo-ku, Kyoto City, Kyoto
616-8255
Japan
Fukushima Medical University Hospital
Fukushima-shi, Fukushima
960-1295
Japan
Murakami Karindoh Hospital
Nishi-ku, Fukuoka-shi, Fukuoka
819-8585
Japan
National Hospital Organization Hokkaido Medical Center
Sapporo-shi, Hokkaido
063-0005
Japan
National Hospital Organization Iou National Hospital
Kanazawa-shi, Ishikawa
920-0192
Japan
Kagawa University Hospital
Miki-cho, Kita-gun, Kagawa
761-0793
Japan
Yokohama City University Hospital
Kanazawa-ku, Yokohama-shi, Kanagawa
236-0004
Japan
Kitasato University Hospital
Minami-ku, Sagamihara-city, Kanagawa
252-0375
Japan
National Hospital Organization Kumamoto Saishun Medical Center
Koshi-shi, Kumamoto
861-1196
Japan
Seoul National University Hospital
Seoul 03080
Korea, Republic of
Hanyang University Medical Center
Seoul 04763
Korea, Republic of
Samsung Medical Center
Seoul 06351
Korea, Republic of
University hospital Bern (Inselspital)
Bern, BE
3010
Switzerland
Hopitaux Universitaires de Geneve (HUG) (Hopital Cantonal)
Geneve 1205
Switzerland
Neurocenter of Southern Switzerland
Lugano 6903
Switzerland
Zentrumsleiter Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic
St.Gallen 9107
Switzerland