AVONEX IN TREATING MULTIPLE SCLEROSIS AFTER AN ISOLATED DEMYELINATING EVENT

AVONEX 治疗孤立性脱髓鞘事件后的多发性硬化症

• 批准号: 6220164
• 负责人: SHIRLEY H WRAY
• 金额: $ 0.06万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6220164
• 关键词: brain stem; clinical research; disease /disorder proneness /risk; drug screening /evaluation; human subject; human therapy evaluation; multiple sclerosis; myelinopathy; nervous system disorder chemotherapy; neuropharmacology; optic nerve; spinal cord

The purpose of this study is to delay the onset of clinically definite multiple sclerosis (CDMS) in subjects who have experienced a first and recent onset of a demeyelinating event involving the optic nerve, spinal cord, or brainstem, and who are at high risk for multiple sclerosis (MS). The primary endpoint of the study will be the time to developement of CDMS as determined by the onset of a new neurological event, i.e., new neurological symptoms lasting more than 48 hours in a subject who had been neurologically stable or improving at least 30 days following initiation of study drug treatment. Secondary endpoints include change in T2 lesion volume from baseline to Year 3, number and volume of gadolinium-enhanced lesions at Year 3, and number of new or enlarged T2 hyperintense lesions at Year 3. One interm efficacy analysis will be performed after all subjects have completed 2 years of treatment. The study is sized under the assumption that 50% of subjects treated with placebo will reach CDMS by 3 years and that treatment with AVONEX tm will reduce this percentage to 33%. Interm safety analyses will be performed at intervals throughout the study.

本研究的目的是延迟临床明确的多发性硬化症（CDMS）的发病，这些患者首次或近期发生涉及视神经、脊髓或脑干的脱髓鞘事件，并且是多发性硬化症（MS）的高危人群。研究的主要终点将是CDMS发展的时间，由新的神经系统事件的发生决定，即在开始研究药物治疗后至少30天神经系统稳定或改善的受试者中，新的神经系统症状持续超过48小时。次要终点包括从基线到第3年T2病变体积的变化，第3年钆增强病变的数量和体积，第3年新发或扩大的T2高强度病变的数量。在所有受试者完成2年治疗后，将进行一次中期疗效分析。该研究是在假设50%接受安慰剂治疗的受试者将在3年内达到CDMS，而AVONEX™治疗将使这一比例降低至33%的情况下进行的。在整个研究过程中，将间隔进行中期安全性分析。