PHASE III TRIAL OF MINOCYCLINE IN AMYOTROPHIC LATERAL SCLEROSIS

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 我们将在这项研究中检验的假设是米诺环素延缓ALS患者整体功能的进行性恶化。主要的结果衡量标准是服用米诺环素的患者与服用安慰剂的患者相比，ALS功能评定量表检测到的功能变化。这项研究有80%的能力检测到随着时间的推移，患者ALSFRS-R评分的平均斜率下降了15%或更多。次要结果指标是手动肌肉测试(MMT)、用力肺活量(FVC，预测百分比)和存活率的变化。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The hypothesis we will test in th current study is that minocycline slows the progessive deterioration of global function in patients with ALS. The primary outcome measure is change in the function as detected by the ALS Functional Rating Scale in patients taking minocycline compared to those taking placebo. The stuyd is 80% powered to detect A 15% or greater reduction in the average slope of patients' ALSFRS-R scores over time. The secondary outcome measures are changes in manual muscle testing (MMT), forced vital capacity (FVC, percent predicted) and survival.