Phase 2-3 Use of Bacille Calmette-Guèrin (BCG) Vaccine in Patients With a First Clinical Demyelinating Episode: a Multicenter, Randomized, Single Blind Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- number of gad-enhancing lesions in T1
研究概览
简要总结
The frequency of auto-immune diseases (including multiple sclerosis) is increasing in industrialised countries.
According to an hypothesis which is receiving a wide international credit, this may be due to the fact that the populations of these countries are increasingly less exposed to microbes further to the improvement of hygienic conditions and to the use of antibiotics.
If exposure to microbes is lacking, also their regulatory function is missed with a consequent possible onset of auto-immune symptoms.
For this reason, it is deemed that by exposing the immune system of a patient to an ancient microbe, being complex and important in man evolution, like the Tuberculosis Mycobacterium, it is possible to rebalance the immune system.
详细描述
Vaccination with the Tuberculosis Mycobacterium has proved to be effective in the animal model of multiple sclerosis, experimental allergic encephalitis.
In a study of phase I-II our group has demonstrated the safety of this therapy together with preliminary evidence.
The study includes patients with an initial disease (diagnosis supported by paraclinical criteria): single clinical poly or mono-symptomatic attack in the 6 months preceding the study, MR picture compatible with MS.
Study design 100 randomized patients (i.e. randomly assigned) to be included either in a group of 50 patients undergoing therapy or to a group of 50 patients receiving placebo.
Patients are followed up with monthly contrast MRI for 6 months. At the end of the six months the disease activity in the group of treated patients is benchmarked with the disease activity of the group of patients receiving placebo.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an initial disease (diagnosis supported by paraclinical criteria): single clinical poly or mono-symptomatic attack in the 6 months preceding the study, MR picture compatible with MS
排除标准
- •Therapy with corticosteroids in the last month
- •Plasmapheresis, administration of gamma globulins in the last three months
- •Serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
- •Evidence of infections
- •Evidence of tubercular disease
结局指标
主要结局
number of gad-enhancing lesions in T1
时间窗: baseline and 6 months
number of lesions in T1 and new lesions in T2
时间窗: baseline and 6 months
次要结局
- volume of T2 lesions(0 and 6 months)
- volume of T1 lesions (black holes)(0 and 6 months)