Oxidative Markers and Efficacy in Amyotrophic Lateral Sclerosis (ALS) Phenotypes Treated With Edaravone
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.
研究概览
简要总结
This study is being conducted to help the investigators better understand how the new FDA approved medication Edaravone (also known as Radicava) works in subsets of patients with ALS. The investigators are also trying to understand if there are specific ALS patients, with different presentations of ALS, who might benefit most from this medication. Also, the investigators are following specific biomarkers to determine the optimal treatment duration in patients with different forms of ALS
There is no study medication being offered in this trial. Edaravone is prescribed as part of regular care. In this trial we are collecting blood, urine, and spinal fluid samples in ALS patients who are taking Edaravone and ALS patients who are not taking Edaravone to measure certain markers that could indicate why the drug may be working in a specific type of ALS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Either possible, probable, or definite ALS, predominantly lower motor neuron disease, predominantly upper motor neuron disease, or bulbar
- •With or without cognitive involvement
- •Willing to participate
- •On no experimental treatment
- •Ages 18 - 85
- •No prior exposure to Edaravone (Radicava)
- •On a stable dose of Riluzole for 30 days or off Riluzole
- •Male or female
- •Females of childbearing age must use contraception
排除标准
- •Unstable medical illness
- •Abnormal liver function (>2x ULN)
- •Unlikely to survive for 26 weeks
结局指标
主要结局
Define pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in different ALS/MND phenotypes.
时间窗: 6 months
The investigators aim to identify 4 cohorts of patients with distinct ALS/MND phenotypes and measure a panel of pharmacodynamic biomarkers of oxidative stress and antioxidant capacity in the CSF, blood, and urine.
次要结局
未报告次要终点