NCT04165824已完成3 期
Safety Study of Oral Edaravone Administered in Subjects With ALS
Shionogi106 个研究点 分布在 6 个国家目标入组 185 人开始时间: 2019年11月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 106
- 主要终点
- Number of Participants With Treatment Emergency Adverse Events
研究概览
简要总结
The objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) over 24 and 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects will be male or female, ≥ 18 to 75 years of age at the time the ICF is signed
- •Subjects will be diagnosed with Definite ALS, Probable ALS, Probable laboratory-supported ALS, or Possible ALS according to the El Escorial revised criteria for the diagnosis of ALS.
- •Subjects will be living and functioning independently (eg, able to eat, excrete, ambulate independently without assistance of others). The use of supportive tools and adaptive utensil is allowed
- •Subjects will have a baseline forced vital capacity percentage (%FVC) ≥ 70%.
- •Subjects whose first symptom of ALS occurred within 3 years of the time of providing written informed consent.
排除标准
- •Subjects who have the presence or history of any clinically significant disease (except ALS) that could interfere with the objectives of the study (the assessment of safety and efficacy) or the safety of the subject, as judged by the Investigator.
- •Subjects of childbearing potential unwilling to use 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.
- •Subjects who are female and pregnant (a positive pregnancy test) or lactating at the screening visit (Visit 1).
- •Subjects who have a significant risk of suicidality. 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) within the 3 months before the screening visit.
- •Subjects who have ALT or AST elevations greater than 2 times the ULN at screening.
- •Subjects with a Glomerular Filtration Rate (GFR) <30 mL/Min Per 1.73 m
- •Subjects with history of hypersensitivity to edaravone, any of the additives or inactive ingredients of edaravone, or sulfites.
- •Subjects with hereditary fructose intolerance.
- •Subjects who participated in another study and were administered an investigational product within 1 month or 5 half-lives of the investigational agent, whichever is longer before providing informed consent for the present study.
- •Subjects who are unable to take their medications orally.
研究组 & 干预措施
MT-1186
Experimental
干预措施: MT-1186 (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergency Adverse Events
时间窗: Up to 48 Weeks
Number of Treatment Emergency Adverse Events
时间窗: up to 48 Weeks
次要结局
未报告次要终点
研究者
研究点 (106)
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