Minocycline to Improve Neurologic Outcome in Stroke (MINOS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Maximally Tolerated Dose of IV Minocycline
研究概览
简要总结
The primary aim of this study is to find out which of 4 different doses of minocycline are safe and well tolerated so that we will know the optimal dose to test in future patients.
详细描述
Minocycline is a widely used antibiotic and is approved by the Food and Drug Administration (FDA) for treatment of infections and acne. However, doctors do not know whether minocycline will work in stroke patients. Its use in stroke patients is experimental. There is a lot of information from experimental stroke studies in animals that minocycline lessens the damage from a stroke and the animals recover better. Since minocycline is generally a very safe drug in humans and does not have a lot of side effects, investigators at Georgia Health Sciences University (formerly the Medical College of Georgia) believe that it might be a safe and effective drug to improve the outcome in patients with stroke.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •over 18 years of age
- •acute onset focal neurologic deficit consistent with acute ischemic stroke, or computed tomographic scan consistent with acute cerebral ischemia
- •onset of symptoms less than 6 hours
- •measurable neurologic deficit (National Institutes of Health [NIH] Stroke Scale >/= 1)
排除标准
- •allergy to tetracycline antibiotics
- •women of child-bearing potential
- •known hepatic and/or renal insufficiency
- •Thrombocytopenia
- •history of intolerance to minocycline
- •dizziness at the time of stroke or in the past month (by self-report)
- •aphasia likely to interfere with patients ability to report adverse effects
- •previous functional disability
- •stuporous or comatose
- •presence of another serious illness likely to confound the study
- •unlikely to be available for 90 day follow-up
- •severe stroke (National Institutes of Health [NIH] Stroke Scale >22)
- •undergoing an interventional neuro-radiological intervention in first 12 hour
结局指标
主要结局
Maximally Tolerated Dose of IV Minocycline
时间窗: 3 days
Investigators closely monitored each subject for evidence of minocycline intolerance. All adverse events were immediately reported for a decision whether to discontinue the study medication and/or reduce the dose. A computer program was used to determine the maximum tolerated dose. After entering information regarding doses and expected toxicities, results for each subject as they were collected were entered. The computer program informed as to (de)escalation, or maintenance of the same dose in the subsequent cohort of enrolled patients.
次要结局
- Half-life of IV Minocycline(For each subject blood samples were drawn before dose #1 and one hour after starting dose #1. Additional blood was drawn 1, 6, 12, 24, 48, and 72 hours after starting dose #6, which lasted approximately 6 days.)
- 90 Day Modified Rankin Scale Score(3 months)
研究者
David Hess, MD
Professor and Chairman
Augusta University