Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Phase 3

Completed

• Conditions: Amyotrophic Lateral Sclerosis (ALS)
• Interventions: Drug: MT-1186

• Registration Number: NCT04577404
• Lead Sponsor: Mitsubishi Tanabe Pharma America Inc.

Brief Summary

This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-30
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-06
• Study Start: 2020-10-29
• Primary Completion: 2023-08-09
• Study Completion: 2023-08-09
• Results First Submitted: 2024-07-29
• Status Verified: 2024-08
• Results First Submitted QC: 2024-08-27
• Last Update Submitted: 2024-08-27
• Results First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

1. Subjects must provide 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.
2. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
3. Subjects who successfully completed Study MT-1186-A01.

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Exclusion Criteria

1. Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication.
2. 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 C-SSRS at Visit
3. Subjects who are not eligible to continue in the study, as judged by the Investigator.
4. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MT-1186	MT-1186	Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period

Primary Outcome Measures

Name	Time	Method
Number of Events of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESEAs, TEAEs Leading to Discontinuation, Any TEAEs Leading to Death	up to 96 Weeks	AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.; * Severe TEAEs: TEAEs which was classified as severe for the severity were analyzed. The severity of TEAEs was classified according to the following criteria: Mild (The event is transient and easily tolerated by the subject.), Moderate: The event causes discomfort and interferes with the subject's general condition.), and Severe (The event causes considerable interference with the subject's general condition and may be incapacitating.); * TESAEs, which is Serious TEAEs, is the TEAEs when the patients outcome is death, life-threatening, hospitalization, or disability or permanent damage.
Number of Subjects of Treatment Emergency Adverse Events (TEAEs), Adverse Drug Reactions (ADRs), Severe TEAEs, TESAEs, TEAEs Leading to Discontinuation and TEAEs Leading to Death	up to 96 Weeks	AEs that occurred on or after the first dose in the MT-1186-A03 will be summarized, which implies AE that occurred during MT-1186-A01 will not be summarized.

Trial Locations

Locations (44)

National Hospital Organization Kumamoto Saishun Medical Center; 🇯🇵 Koshi-shi, Kumamoto, Japan

Kansai Electric Power Hospital Recruiting; 🇯🇵 Fukushima-ku, Osaka-shi, Osaka, Japan

Tokyo Metropolitan Neurological Hospital; 🇯🇵 Fuchu-city, Tokyo, Japan

Emory University - School of Medicine; 🇺🇸 Atlanta, Georgia, United States

Alleghany General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

CHU-Nice - Hopital Pasteur 2; 🇫🇷 Nice, Cedex 1, France

Penn State Hershey Children's Hospital; 🇺🇸 Hershey, Pennsylvania, United States

Texas Neurology, PA; 🇺🇸 Dallas, Texas, United States

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Lower Saxony, Germany

Neuromuscular Research Center; 🇺🇸 Phoenix, Arizona, United States

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation; 🇺🇸 Winston-Salem, North Carolina, United States

UF Health Cancer Center; 🇺🇸 Gainesville, Florida, United States

Woodland Research Northwest; 🇺🇸 Rogers, Arkansas, United States

University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM); 🇨🇦 Edmonton, Alberta, Canada

Montreal Neurological Institute and Hospital; 🇨🇦 Montreal, Quebec, Canada

National Hospital Organization Chibahigashi National Hospital; 🇯🇵 Chiba-shi, Chiba, Japan

Murakami Karindoh Hospital; 🇯🇵 Fukuoka-city, Fukuoka, Japan

Shiga University of Medical Science Hospital; 🇯🇵 Otsu-shi, Shiga, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo-ku, Tokyo, Japan

National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders; 🇯🇵 Shizuoka-city, Shizuoka, Japan

Centre Hospitalier Esquirol; 🇫🇷 Limoges, Marcland, France

Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre); 🇮🇹 Milan, Italy

National Hospital Organization Iou National Hospital; 🇯🇵 Kanazawa-shi, Ishikawa, Japan

Heritage Medical Research Clinic - University Of Calgary; 🇨🇦 Calgary, Alberta, Canada

St. Joseph's Hospital and Medical Center (SJHMC) - Barrow Neurological Institute (BNI) - The Gregory W. Fulton ALS and Neuromuscular Disease Center; 🇺🇸 Phoenix, Arizona, United States

Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele); 🇮🇹 Milano, Lombardia, Italy

Fukushima Medical University Hospital; 🇯🇵 Fukushima-shi, Fukushima, Japan

National Hospital Organization Hokkaido Medical Center; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Kagawa University Hospital; 🇯🇵 Kita-gun, Kagawa, Japan

Yokohama City University Hospital; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Hopital Pierre Wertheimer - Hopital Neurologique; 🇫🇷 Paris, France

Centre Hospitalier Universitaire (CHU) de Bordeaux; 🇫🇷 Bordeaux, France

Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA); 🇮🇹 Turin, Piemonte, Italy

Tohoku University Hospital; 🇯🇵 Sendai-city, Miyagi, Japan

Niigata University Medical And Dental Hospital; 🇯🇵 Niigata-shi, Niigata, Japan

Deutsche Klinik fuer Diagnostik; 🇩🇪 Wiesbaden, Hessen, Germany

Aichi Medical University Hospital; 🇯🇵 Nagakute-shi, Aichi, Japan

Kitasato University Hospital; 🇯🇵 Sagamihara-city, Kanagawa, Japan

National Hospital Organization Toneyama Medical Center; 🇯🇵 Toyonaka-shi, Osaka, Japan

Toho University Omori Medical Center; 🇯🇵 Ota-ku, Tokyo, Japan

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Neurology Associates, P.C - Lincoln; 🇺🇸 Lincoln, Nebraska, United States