EFFICACY AND SAFETY OF COPOLYMER I IN PATIENTS WITH MULTIPLE SCLEROSIS

共聚物 I 对多发性硬化症患者的功效和安全性

• 批准号: 3788653
• 负责人: Jerry Saul Wolinsky
• 金额: --
• 依托单位: UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/3788653
• 关键词: clinical trials; copolymer; drug screening /evaluation; human subject; human therapy evaluation; injection /infusion; multiple sclerosis; nervous system disorder chemotherapy; relapse /recurrence; synthetic peptide

This is a double-blind, placebo controlled multicenter Phase III study. The purpose of the study is to determine whether 20 mg of Copolymer I administered by subcutaneous injection daily for 24 months to patients with relapsing-remitting multiple sclerosis reduces the number of relapses as compared to placebo. It also compares the safety and tolerance of Copolymer I and placebo.

这是一项双盲、安慰剂对照、多中心III期研究。 该研究的目的是确定20 mg共聚物I 每日皮下注射给药，持续24个月 复发缓解型多发性硬化症的患者， 与安慰剂相比复发。 它还比较了安全性和 共聚物I和安慰剂的耐受性。