NCT02149706Unknown2 期
A Phase IIb Study of NeuroVax™, a Novel Therapeutic TCR Peptide Vaccine for SPMS of Multiple Sclerosis Slowing Disease Progression Via Vaccination
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
研究概览
简要总结
Multi-center, randomized , double-blind, placebo-controlled , two arm parallel design study of NeuroVax™ vs. Incomplete Freund's Adjuvant ( I F A) placebo. 150 subjects with Secondary Progressive SPMS.
详细描述
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 18 Years to 70 Years
- •Genders Eligible for Study: Both
- •Accepts Healthy Volunteers: No Criteria
- •Subject is between 18 and 70 years of age, inclusive.
- •Definite MS by the revised McDonald criteria (2005) (Appendix A), with a Secondary Progressive course.
- •Expanded Disability Status Scale (EDSS) >=score 3.5 (Appendix B).
- •Two or more documented clinical relapses of MS in the preceding 24 months OR one documented clinical relapse of MS in the preceding 1 2 months prior to screening .
- •Laboratory values within the following limits:
- •Creatinine 1 . 5 x high normal.
- •Hemoglobin
排除标准
- •Subjects currently prescribed Campath or Lemtrada
结局指标
主要结局
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS score
时间窗: 48 Weeks
The primary objective is to compare between treatment groups the Measures of neurologic disability EDSS scores improvements
次要结局
- Secondary measurements objectives immunologic evaluations(48 Weeks)
研究者
研究点 (2)
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