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.

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