NCT00104143撤回2 期
A Randomized, Double-blind, Placebo Controlled Dose-ranging Study to Determine the Effect on MRI Lesions and Safety of A4I Antagonist in Relapsing Multiple Sclerosis.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 39
- 主要终点
- Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
研究概览
简要总结
This study will compare the effect of A4I antagonist and placebo on MRI lesions,on clinical endpoints, and safety in patients with relapsing Multiple Sclerosis (MS). Eligible patients will be randomized to receive placebo or A4I antagonist, 20mg, 80mg or 300mg, po bid. Patients will undergo MRI brain scans and MS clinical evaluations at intervals throughout the study. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-59 years of age;
- •relapsing multiple sclerosis patients with types 1-4 (established through McDonald criteria);
- •>=1 MS attack or a Gd-enhancing MRI lesion between 1 month and 1 year before enrollment;
- •EDSS score of <=6.5;
- •inadequate response to approved treatment(Canada only).
排除标准
- •MS attack within 1 month before enrollment;
- •systemic corticosteroids within 1 month before enrollment;
- •MS treatments (non-symptomatic) within specified periods before enrollment;
- •an infection requiring systemic anti-infective treatment or vaccination with a live vaccine within 1 month before enrollment.
结局指标
主要结局
Cumulative number of new gadolinium-enhancing MRI lesions during double-blind treatment period
次要结局
- No. of new active MRI lesions; no. of patients with >=1 objective/subjective MS attack; total no. of MS attacks; no. of patients requiring systemic corticosteroids; change from baseline to wk 12 in EDSS
研究者
研究点 (39)
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