Randomized Clinical Trial to Investigate Whether Administration of CBG000592 (Riboflavin/Vitamin B2) in Patients With Acute Ischemic Stroke Causes a Reduction of Glutamate-mediated Excitotoxicity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Reduction of serum glutamate concentration
研究概览
简要总结
Administration of CBG000592 (riboflavin/vitamin B2) in patients with acute ischemic stroke to know if it causes a reduction of glutamate-mediated excitotoxicity.
详细描述
The investigators hypothesis focuses on the effect of riboflavin given for the first three hours of ischemic stroke, as a reducing agent of cerebral glutamate concentration. This administration would produce a reduction of excitotoxic damage and consequently generate clinical improvement, while a lower income and a better functional outcome of patients at three months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years, both men and women.
- •Patient or legal representative able to understand and sign the informed consent.
- •Patients with suspected stroke within 3 hours of onset.
排除标准
- •Women of childbearing age, with potential for pregnancy or breastfeeding.
- •Patients with a score ≥ 2 point 1a in the NIHSS scale.
- •Scale pre-stroke modified Rankin ≥
- •Inability to prior testing image needed for the study.
- •Previous disorders that may interfere with the interpretation of neurological scales.
- •Treatment with probenecid, tricyclic antidepressants, phenothiazines, streptomycin, erythromycin, tyrothricin, tetracyclines and carbomycin, at the time of inclusion.
研究组 & 干预措施
Vitamin B2 Streuli®
20mg IV
干预措施: Vitamin B2 Streuli® (Drug)
Solution for injection
4ml IV
干预措施: Solution for injection (Other)
结局指标
主要结局
Reduction of serum glutamate concentration
时间窗: 7 hours
Difference between serum glutamate concentration from basal (prior to medication infusion) and levels at 3 ± 1 and 6 ± 1 hours, from administered medication, including branch CBG000592 (riboflavin/vitamin B2) and placebo.
次要结局
- Functional outcome using Rankin Scale at 90 days(3 months)
- Days of hospitalisation(3 months)
- Prognosis of patients using Rankin Scale at 90 days(3 months)
- Percentage of clinical improvement (basal-high)(3 months)
- Serum glutamate concentrations(7 hours)
- Number of participants with Adverse Event(3 months)