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

Mitsubishi Tanabe Pharma Development America, Inc.0 个研究点目标入组 100 人开始时间: 2020年11月12日最近更新: 2024年1月8日

研究概览

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•1. Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgement 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•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. Refer to Appendix 2 of the Protocol for additional contraceptive information.
•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 Columbia-Suicide Severity Rating Scale (C-SSRS) at Visit 1.
•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.

发起方

Mitsubishi Tanabe Pharma Development America, Inc.