JPRN-jRCT2041200084已完成3 期
A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Kondo Kazuoki0 个研究点目标入组 140 人开始时间: 2020年12月24日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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 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.
研究者
相似试验
进行中（未招募）
1 期
A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-000376-38-DEMitsubishi Tanabe Pharma Development America, Inc.140
进行中（未招募）
1 期
A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)EUCTR2020-000376-38-FRMitsubishi Tanabe Pharma Development America, Inc.100
进行中（未招募）
1 期
A Safety Extension Study of Oral Edaravone in Subjects with Amyotrophic Lateral Sclerosis (ALS)Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2020-000376-38-ITMitsubishi Tanabe Development America Inc.100
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-ESCSL Behring GmbH97
进行中（未招募）
1 期
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) in Patients with Hemophilia BHemophilia BEUCTR2012-005489-37-ATCSL Behring GmbH99