A Phase 3b, Multicenter, Randomized, Double-blind Extension Study to Evaluate the Continued Efficacy and Safety of Oral Edaravone Administered for an Additional Period of up to 48 Weeks Following Study MT-1186-A02 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Mitsubishi Tanabe Pharma America, Inc. (MTPA)0 个研究点目标入组 300 人开始时间: 2022年3月17日最近更新: 2024年7月8日

适应症

试验速览

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•Subjects who meet all of the following criteria will be considered eligible to participate in Study MT-1186-A04:
•1. Subjects or their legally authorized representative must provide a signed and dated informed consent form to participate in the study.
•2. 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.
•3. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements.
•4. Subjects must have successfully completed all Study MT-1186-A02 visits and have been compliant with study drug.
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 150

•Subjects who meet any of the following criteria will be excluded from the study:
•1. Subjects of childbearing potential unwilling to use an acceptable method of contraception from the screening visit until 3 months after the last dose of study medication. Subjects who are sexually active who do not agree to use contraception during the study period. Refer to Appendix 3 for additional contraceptive information.
•2. Subjects who are female, of childbearing potential, and pregnant (a positive pregnancy test) or lactating at the screening visit.
•3. 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 Week 48 of Study MT-1186-A02.
•4. Subjects who are not eligible to continue in the study, as judged by the Investigator in conjunction with the MTDA medical monitor.
•5. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

发起方

Mitsubishi Tanabe Pharma America, Inc. (MTPA)