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COPAXONE IN PATIENTS WITH MULTIPLE SCLEROSIS--OPEN LABEL STUDY

COPAXONE IN PATIENTS WITH MULTIPLE SCLEROSIS--OPEN LABEL STUDY
科帕松治疗多发性硬化症患者——开放标签研究
批准号:
6281659
负责人:
Jerry Saul Wolinsky
金额:
$1.36万
依托单位国家:
美国
项目类别:
财政年份:
1997
资助国家:
美国
项目状态:
已结题
起止时间:
1997-12-01 至 1998-11-30

项目摘要

项目成果

Jerry Saul Wolinsky的其他基金

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中文摘要
翻译
这项研究是最初的安慰剂对照试验的扩展 测定共聚物I治疗慢性阻塞性肺疾病患者的安全性和有效性 复发-缓解性多发性硬化症。3期对照试验 结果表明,用共聚物1处理可以有效地减少 临床复发和减缓累积的神经功能障碍 与接受安慰剂治疗的患者相比。大多数完成这一阶段的患者 3项安慰剂对照研究被选入这项开放标签的研究 共聚物1的长期安全性和安全性测定的推广研究 明显的疗效持续性。这项研究将延长一年 至少额外两年,并对所有入学学生进行评估 接受年度定量磁共振成像的患者, 在德克萨斯大学休斯顿分校进行的集中图像分析, 健康科学中心。
英文摘要
This study is an extension of the original placebo-controlled trial to determine the safety and efficacy of Copolymer I in patients with relapsing-remitting multiple sclerosis. The controlled phase 3 trial showed that treatment with copolymer 1 was effective in reducing the clinical relapses and in slowing accumulated neurological disability compared to placebo treated patients. Most patients completing the phase 3 placebo controlled study elected to enroll in this open-labeled extension study of copolymer 1 for determination of long term safety and apparent persistence of efficacy. The study will be extended for a minimum of two additional years with the evaluation of all enrolled patients with annual quantitative magnetic resonance imaging, with centralized image analysis conducted at the University of Texas-Houston, Health Science Center.
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会议论文
AVONEX IN TREATMENT OF SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS
HU23F2G IN ACUTE EXACERBATIONS OF MULTIPLE SCLEROSIS
AVONEX IN TREATMENT OF SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS
COPAXONE IN PATIENTS WITH MULTIPLE SCLEROSIS--OPEN LABEL STUDY
海外基金