A Multicenter, Open-label Extension Study to Investigate the Long-term Safety of FAB122 in Patients With Amyotrophic Lateral Sclerosis
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Treatment Emergent Adverse Events
研究概览
简要总结
A multicenter, open-label extension study to investigate the long-term safety of FAB122 in patients with Amyotrophic Lateral Sclerosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
All subjects were treated with FAB122 in ADOREXT study, arms from parent study ADORE have been analyzed.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •who completed the full study period in the main ADORE study (FAB122-CT-2001);
- •whom the investigator has no concern and judges tolerable for initiating or continuing treatment with FAB122 from a risk and benefit point of view;
- •a female subject should not be able to become pregnant up to 30 days after the last dose of FAB122 and needs to meet at least one of the following criteria:
- •female who is of reproductive potential and has a negative pregnancy test at baseline and is non-lactating.
- •female subject who is not of reproductive potential is eligible without requiring the use of contraception
- •a male patient must:
- •agree he will not donate sperm during the period he will be using FAB122, AND use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential
排除标准
- •Patient who has a medical condition or personal circumstances which, in the opinion of the investigator, will make initiation or continuation of treatment with FAB122 not tolerable for them from a risk and benefit point of view.
- •Patient who discontinued study drug prematurely in the double-blind phase of the study (ADORE Study) for safety reasons.
- •Patient who has received any other investigational drug within the period between last visit of the main study and first visit of the extension study
研究组 & 干预措施
FAB122
Drug: FAB122 Daily dose 100 mg
Data presented for the FAB122 study group correspond to subjects receiving FAB122 in the ADORE study as well as the ADOREXT study (FAB122-FAB122).
干预措施: FAB122 (Drug)
Placebo
Drug: FAB122 Daily dose 100 mg
Data presented for the placebo study group correspond to subjects receiving placebo in the ADORE study and FAB122in the ADOREXT study (placebo-FAB122).
干预措施: FAB122 (Drug)
结局指标
主要结局
Number of Participants Experiencing Treatment Emergent Adverse Events
时间窗: approximately 44 weeks
To evaluate the long-term safety of FAB122 in patients with ALS by assessing Number of Participants experiencing Treatment Emergent Adverse Events, evaluating nature and severity. The study duration for these subjects, and therefore the duration of FAB122 treatment, was variable depending on the subject's start date, ranging from 3 to approximately 44 weeks.
次要结局
- The Secondary Efficacy Objective to Evaluate the Effect of Treatment With FAB122 Based on Change From Baseline in ALSFRS-R Until End of Study(45 weeks)