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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：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
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
来源：
https://reporter.nih.gov/project-details/6281659
关键词：
clinical research clinical trials copolymer I drug screening /evaluation human subject human therapy evaluation longitudinal human study medical complication multiple sclerosis nervous system disorder chemotherapy nervous system disorder diagnosis relapse /recurrence

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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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COPAXONE IN PATIENTS WITH MULTIPLE SCLEROSIS--OPEN LABEL STUDY
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