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

Amyotrophic Lateral Sclerosis (ALS) Clinical Trial

Official title:

A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577404
• Other study ID #: MT-1186-A03
• Secondary ID: 2020-000376-38
• Status: Completed
• Phase: Phase 3
• Start date: October 29, 2020
• Est. completion date: August 8, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 8, 2023
• Est. primary completion date: August 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis (ALS)
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• MT-1186
Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.

Locations

Country	Name	City	State
Canada	Heritage Medical Research Clinic - University Of Calgary	Calgary	Alberta
Canada	University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM)	Edmonton	Alberta
Canada	Recherche Sepmus, Inc.	Greenfield Park	Quebec
Canada	Montreal Neurological Institute and Hospital	Montreal	Quebec
France	Centre Hospitalier Universitaire (CHU) de Bordeaux	Bordeaux
France	Centre Hospitalier Esquirol	Limoges	Marcland
France	CHU-Nice - Hopital Pasteur 2	Nice	Cedex 1
France	Hopital Pierre Wertheimer - Hopital Neurologique	Paris
Germany	Medizinische Hochschule Hannover	Hannover	Lower Saxony
Germany	Deutsche Klinik fuer Diagnostik	Wiesbaden	Hessen
Italy	Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre)	Milan
Italy	Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele)	Milano	Lombardia
Italy	Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA)	Turin	Piemonte
Japan	Juntendo University Hospital	Bunkyo-ku	Tokyo
Japan	National Hospital Organization Chibahigashi National Hospital	Chiba-shi	Chiba
Japan	Tokyo Metropolitan Neurological Hospital	Fuchu-city	Tokyo
Japan	Murakami Karindoh Hospital	Fukuoka-city	Fukuoka
Japan	Kansai Electric Power Hospital Recruiting	Fukushima-ku, Osaka-shi	Osaka
Japan	Fukushima Medical University Hospital	Fukushima-shi	Fukushima
Japan	National Hospital Organization Iou National Hospital	Kanazawa-shi	Ishikawa
Japan	Kagawa University Hospital	Kita-gun	Kagawa
Japan	National Hospital Organization Kumamoto Saishun Medical Center	Koshi-shi	Kumamoto
Japan	Aichi Medical University Hospital	Nagakute-shi,	Aichi
Japan	Niigata University Medical And Dental Hospital	Niigata-shi	Niigata
Japan	Toho University Omori Medical Center	Ota-ku	Tokyo
Japan	Shiga University of Medical Science Hospital	Otsu-shi	Shiga
Japan	Kitasato University Hospital	Sagamihara-city	Kanagawa
Japan	National Hospital Organization Hokkaido Medical Center	Sapporo-shi	Hokkaido
Japan	Tohoku University Hospital	Sendai-city	Miyagi
Japan	National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders	Shizuoka-city	Shizuoka
Japan	National Hospital Organization Toneyama Medical Center	Toyonaka-shi	Osaka
Japan	Yokohama City University Hospital	Yokohama-shi	Kanagawa
United States	Emory University - School of Medicine	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Johns Hopkins University School of Medicine	Baltimore	Maryland
United States	Wesley Neurology Clinic, P.C.	Cordova	Tennessee
United States	Texas Neurology, PA	Dallas	Texas
United States	UF Health Cancer Center	Gainesville	Florida
United States	Penn State Hershey Children's Hospital	Hershey	Pennsylvania
United States	Neurology Associates, P.C - Lincoln	Lincoln	Nebraska
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Lewis Katz School of Medicine at Temple University	Philadelphia	Pennsylvania
United States	Neuromuscular Research Center	Phoenix	Arizona
United States	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	Alleghany General Hospital	Pittsburgh	Pennsylvania
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma America Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Italy,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline to week 96	ALS Functional Rating Scale- Revised (ALSFRS-R). 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.	Baseline to Week 96
Other	Time (days) to death, tracheostomy, or permanent assisted mechanical ventilation (>= 23 hours/day)		Baseline to Week 96
Primary	Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs])		Baseline to Week 96