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

Shionogi124 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

124

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Interventions

MT-1186DRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (44)

Outcomes

Primary Outcomes

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

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.

Time frame: up to 96 Weeks

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

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.

Time frame: up to 96 Weeks

Data from ClinicalTrials.gov

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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

...and 34 more locations