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 time from the randomization date in Study MT-1186-A02 to at least a 12-point decrease in Revised ALS Functional Rating Score (ALSFRS-R) or death, whichever happens first, over the course of the study or until oral edaravone is commercially available in that countryStudy Status:
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
Clinical Trials Information Desk, to prevent miscommunication, / email hidden; JavaScript is required / Please E-mail
Study Sponsor:
Mitsubishi Tanabe Pharma America Inc.
Estimated Enrollment:
300
Estimated Study Start Date:
01 / 11 / 2022
Estimated Study Completion Date:
06 / 01 / 2024
Posting Last Modified Date:
05 / 15 / 2023
Date Study Added to neals.org:
12 / 09 / 2021
Minimum Age:
18 Years
Maximum Age:
N/A
Inclusion Criteria:1. Subjects or their legally authorized representative must provide a signed and dated informed consent form to participate in the study.
2. 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.
3. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.
Exclusion Criteria:
1. Subjects of childbearing potential unwilling to use an acceptable method of contraception from the Day 1/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.
2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the Day 1/screening visit.
3. Subjects who have a significant risk of suicide. 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) at Week 48 of Study MT-1186-A02.
4. Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.
Woodland Research Northwest, LLC | Recruiting
Rogers, Arkansas
72758
United States
UF Health Cancer Center/Clinical Trials Office | Recruiting
Gainesville, Florida
32610-3633
United States
Emory University - School of Medicine | Recruiting
Atlanta, Georgia
30317-2819
United States
Northwestern University Feinberg School of Medicine | Recruiting
Chicago, Illinois
60611-2605
United States
Johns Hopkins University | Recruiting
Baltimore, Maryland
21205
United States
Neurology Associates, P.C - Lincoln | Recruiting
Lincoln, Nebraska
68506
United States
University Of Pittsburgh Medical Center | Recruiting
Pittsburgh, Pennsylvania
15213
United States
Nerve And Muscle Center Of Texas | Recruiting
Houston, Texas
77019
United States
University of Washington Medical Center | Recruiting
Seattle, Washington
98195
United States
West Virginia University School of Medicine (WVUSoM) - Movement Disorder Clinic | Recruiting
Morgantown, West Virginia
26506-9180
United States
University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM) | Recruiting
Edmonton, Alberta
T6G 2B7
Canada
London Health Sciences Centre - University Hospital | Recruiting
London, Ontario
N6A 5A5
Canada
CHU de Quebec-Hopital-Enfant-Jesus | Recruiting
Quebec City, Quebec
G1J 1Z4
Canada
Health Science Center Mcmaster University | Recruiting
Hamilton, Ontario
L8P 1H1
Canada
Universitaetsklinikum Wuerzburg | Recruiting
Würzburg 97080
Germany
Tohoku University Hospital | Recruiting
Sendai, Miyagi
980-8574
Japan
Saitama Neuropsychiatric Institute | Recruiting
Saitama 338-8577
Japan
Toho University Omori Medical Center | Recruiting
Ota-ku, Tokyo
143-8541
Japan
Teikyo University Hospital | Recruiting
Itabashi-ku, Tokyo
173-8606
Japan
Tokyo Metropolitan Neurological Hospital | Recruiting
Fuchu-city, Tokyo
183-0042
Japan
National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders | Recruiting
Shizuoka-city, Shizuoka
420-8688
Japan
National Hospital Organization Osaka Toneyama Medical Center | Recruiting
Toyonaka, Osaka
560-8552
Japan
Kansai Electric Power Hospital | Recruiting
Osaka-shi, Osaka
553-0003
Japan
Niigata University Medical & Dental Hospital | Recruiting
Niigata-shi, Niigata
951-8520
Japan
Yokohama City University Hospital | Recruiting
Yokohama-shi, Kanagawa
236-0004
Japan
National Hospital Organization Utano National Hospital | Recruiting
Kyoto City, Kyoto
616-8255
Japan
National Hospital Organization Kumamoto Saishun Medical Center | Recruiting
Koshi, Kumamoto
861-1196
Japan
Kagawa University Hospital | Recruiting
Kita-gun, Kagawa
761-0793
Japan
National Hospital Organization Iou National Hospital | Recruiting
Kanazawa-shi, Ishikawa
920-0192
Japan
Hiroshima University Hospital | Recruiting
Hiroshima-shi, Hiroshima
734-8551
Japan
Fukushima Medical University Hospital | Recruiting
Fukushima-shi, Fukushima
960-1295
Japan
Murakami Karindoh Hospital | Recruiting
Fukuoka-city, Fukuoka
819-8585
Japan
National Hospital Organization Chibahigashi National Hospital | Recruiting
Chiba-shi, Chiba
260-8712
Japan
Nagoya University Hospital | Recruiting
Nagoya, Aichi
466-8560
Japan
National Hospital Organization Higashinagoya National Hospital | Recruiting
Nagoya, Aichi
465-8620
Japan
Hanyang University Medical Center | Recruiting
Wangsimni-ro, Seongdong-gu
04763
Korea, Republic of
Chefarzt Muskelzentrum/ALS Clinic Kantonsspital St.Gallen Muskelzentrum/ALS Clinic | Recruiting
St.Gallen 9007
Switzerland