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DOUBLE BLIND STUDY OF R MET HUBDNF GIVEN INTRATHECALLY TO SUBJECTS W/ALS

DOUBLE BLIND STUDY OF R MET HUBDNF GIVEN INTRATHECALLY TO SUBJECTS W/ALS
对 ALS 受试者鞘内注射 R MET HUBDNF 的双盲研究
批准号：
6265607
负责人：
CARLAYNE E JACKSON
金额：
$1.64万
依托单位：
UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
依托单位国家：
美国
项目类别：
财政年份：
1998
资助国家：
美国
项目状态：
已结题
起止时间：
1998-12-01 至 1999-11-30
来源：
https://reporter.nih.gov/project-details/6265607
关键词：
amyotrophic lateral sclerosis clinical research clinical trials human subject human therapy evaluation injection /infusion nervous system disorder chemotherapy neurotrophic factors pharmacokinetics recombinant proteins respirators

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中文摘要
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英文摘要
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety and tolerability of recombinant-Methionyl Human Brain-Derived Neurotrophic Factor (r-metHuBDNF) when given by intrathecal infusion to subjects with amyotrophic lateral sclerosis. It will investigate the efficacy of the study substance on survival and freedom from permanent assisted ventilation. Each subject will receive an implanted pump which will provide either the study substance or a placebo. Upon completion of the study, subjects will have the option to receive open-label r-metHuBDNF for up to 12 months.
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