NCT00004814已完成3 期
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Copolymer 1 for Relapsing-Remitting Multiple Sclerosis
National Center for Research Resources (NCRR)0 个研究点目标入组 250 人开始时间: 1991年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
OBJECTIVES:
I. Compare tolerance to and therapeutic impact of copolymer 1, a mixture of synthetic polypeptides, with placebo in patients with relapsing-remitting multiple sclerosis.
详细描述
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.
One group receives copolymer 1, a mixture of synthetic polypeptides composed of 4 amino acids, subcutaneously each day for 2 years.
The other group receives an injection of placebo daily for 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Clinically or laboratory-supported definite multiple sclerosis
- •Neurologically stable for at least 30 days prior to entry Expanded Disability Status Scale score no greater than 5
- •At least 2 documented relapses within 2 years prior to entry Onset of first relapse at least 1 year prior to randomization
- •-Prior/Concurrent Therapy--
- •Biologic therapy: No prior copolymer 1
- •Immunosuppressive therapy: No prior cytotoxic immunosuppressives, i.e.: Azathioprine Cyclophosphamide Cyclosporine At least 30 days since corticosteroids
- •Radiotherapy: No prior lymphoid irradiation
- •-Patient Characteristics--
- •Not HIV or HTLV-I seropositive No insulin-dependent diabetes mellitus No Lyme disease No requirement for aspirin or chronic nonsteroidal anti-inflammatory drugs No pregnant or nursing women Adequate contraception required of fertile women
排除标准
- 未提供
研究者
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