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

Completed · Phase 3

Conditions studied: Amyotrophic Lateral Sclerosis (ALS)

In brief

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.

Key facts

Study ID

NCT04577404

Run by

Shionogi

People needed

124

Starts

2020-10-29

Expected to finish

2023-08-09

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• 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
• Subjects who are not eligible to continue in the study, as judged by the Investigator.
• Subjects who are unable to take their medications orally or through a PEG/RIG tube.

Where it is running

• 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
• Neuromuscular Research Center — Phoenix, Arizona, United States
• Woodland Research Northwest — Rogers, Arkansas, United States
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States
• UF Health Cancer Center — Gainesville, Florida, United States
• Emory University - School of Medicine — Atlanta, Georgia, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Neurology Associates, P.C - Lincoln — Lincoln, Nebraska, United States
• Wake Forest University Baptist Medical Center (WFUBMC) - The J. Paul Sticht Center on Aging and Rehabilitation — Winston-Salem, North Carolina, United States
• Penn State Hershey Children's Hospital — Hershey, Pennsylvania, United States
• Alleghany General Hospital — Pittsburgh, Pennsylvania, United States
• Texas Neurology, PA — Dallas, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Heritage Medical Research Clinic - University Of Calgary — Calgary, Alberta, Canada
• University of Alberta - Walter C Mackenzie Health Sciences Centre (WCM) — Edmonton, Alberta, Canada
• Montreal Neurological Institute and Hospital — Montreal, Quebec, Canada
• CHU-Nice - Hopital Pasteur 2 — Nice, Cedex 1, France
• Centre Hospitalier Esquirol — Limoges, Marcland, France
• Centre Hospitalier Universitaire (CHU) de Bordeaux — Bordeaux, France
• Hopital Pierre Wertheimer - Hopital Neurologique — Paris, France
• Deutsche Klinik fuer Diagnostik — Wiesbaden, Hesse, Germany
• Medizinische Hochschule Hannover — Hanover, Lower Saxony, Germany
• Ospedale San Raffaele (HSR) (Istituto Scientifico Universitario San Raffaele) — Milan, Lombardy, Italy
• Universita degli Studi di Torino - Centro Regionale Esperto Per La Sclerosi Laterale Amiotrofica (CRESLA) — Turin, Piedmont, Italy
• Fondazione Serena Onlus - Azienda Ospedaliera Niguarda Ca Granda - Centro Clinico Nemo (Neuro Muscular Omnicentre) — Milan, Italy

Full record on ClinicalTrials.gov

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