A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects With Amyotrophic Lateral Sclerosis (ALS)

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 country

Study 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 Development America, Inc.

Clinicaltrials.gov ID:

NCT05151471

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 Development America, Inc.

Estimated Enrollment:

300

Estimated Study Start Date:

01 / 11 / 2022

Estimated Study Completion Date:

06 / 01 / 2024

Posting Last Modified Date:

11 / 16 / 2022

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

Woodland Research Northwest | 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

Health Science Center Mcmaster University | Recruiting

Hamilton, Ontario L8P 1H1
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

Universitaetsklinikum Wuerzburg | Recruiting

W├╝rzburg 97080
Germany

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

Tohoku University Hospital | Recruiting

Sendai, Miyagi 980-8574
Japan

National Hospital Organization Kumamoto Saishun Medical Center | Recruiting

Koshi, Kumamoto 861-1196
Japan

National Hospital Organization Utano National Hospital | Recruiting

Kyoto City, Kyoto 616-8255
Japan

Yokohama City University Hospital | Recruiting

Yokohama-shi, Kanagawa 236-0004
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

London Health Sciences Centre - University Hospital | Recruiting

London, Ontario N6A 5A5
United Kingdom