TRIAL OF MINOCYCLINE IN 400 SUBJECTS WITH ALS

在 400 名 ALS 受试者中进行米诺环素试验

• 批准号: 7605799
• 负责人: RUP TANDAN
• 金额: $ 1.3万
• 依托单位: UNIVERSITY OF VERMONT & ST AGRIC COLLEGE
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605799
• 关键词: Am 80; Amyotrophic Lateral Sclerosis; Computer Retrieval of Information on Scientific Projects Database; Data Analyses; Deterioration; Dose; Evaluation; Funding; Grant; Institution; Intervention; Length; Manuals; Minocycline; Muscle; Outcome Measure; Patient Recruitments; Patients; Phase; Placebos; Preparation; Publications; Quality of life; Randomized; Rate; Research; Research Personnel; Resources; Score; Source; Telephone; Testing; Time; United States National Institutes of Health; Visit; Vital capacity; Week; day; double-blind placebo controlled trial; follow-up; pill

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 the current study is that minocycline slows the progressive deterioration of global function in patients with amyotrophic lateral sclerosis (ALS). The primary outcome measure is change in function as detected by the ALS Functional Rating Scale (ALSFRS-R) in patients taking minocycline compared to those taking placebo. The study is 80 % powered to detect an 18% 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), quality of life (QOL) and survival. This is an investigator-initiated, multi-center, phase III, randomized (1:1), double blind, placebo-controlled trial. The total study length is 48 months: Twenty-four months for patient recruitment, 4 months of serial monthly evaluations to determine baseline slopes of progression for each patient followed by 9 months of intervention (minocycline or placebo), and 11 additional months of survival follow-up, data analysis and preparation of publications. Subjects receive monthly evaluations during their 13 months of participation. Randomization will occur at the month 4 visit. During the first 3 weeks of the intervention phase (month 5) subjects receive an escalating dose of up to 8 pills (400 mg) per day as tolerated and have weekly phone contact.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 我们将在当前研究中检验的假设是，米诺环素在肌萎缩性侧索硬化症患者（ALS）患者中减缓了全球功能的逐步恶化。 与安慰剂相比，在服用米诺环素的患者中，ALS功能评级量表（ALSFRS-R）检测到的功能的主要结果是变化。这项研究有80％的功能，可检测患者ALSFRS-R评分的平均斜率随时间的平均斜率降低18％或更高。次要结果指标是手动肌肉测试（MMT），强迫生命力（FVC，预测百分比），生活质量（QOL）和生存的变化。 这是一个研究者发射的，多中心的第三阶段，随机（1：1），双盲，安慰剂对照试验。总研究长度为48个月：患者招募的二十四个月，4个月的每月串行评估，以确定每位患者的基线斜率，然后进行9个月的干预（米诺环素或安慰剂），以及11个额外的生存随访，数据分析，数据分析和出版物制备。受试者在参与13个月内每月进行评估。随机化将在第4个月访问中发生。在干预阶段的前三周（第5个月），受试者每天接受高达8片（400毫克）的不断升级，可容忍并进行每周电话联系。