Intrathecal Therapy With Monoclonal Antibodies in Progressive Multiple Sclerosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
This is a is a small scale open phase two interventional study to assess long-term stabilising effects of on neurological symptoms by regular intrathecal administered monoclonal antibodies in progressive multiple sclerosis.
详细描述
There is presently no efficient therapy available in progressive MS, especially if there is no clear evidence of active inflammatory lesions or exacerbations as part of the disease. There are, however, evidence that some treatment protocols using cytotoxic drugs may to some extent slow down the progressive course. One specific feature of long-standing MS is that inflammatory cells accumulate in the central nervous system(CNS) compartment in the subarachnoid and perivascular spaces and may therefore be hard to reach via standard drug delivery through systemic administration. Administration of substances via the Intrathecal (IT) route, however, have shown to efficiently distribute in the subarachnoid spaces and may therefore be an attractive route of drug delivery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the age of 18 and 65 years of age (nonfertile women or fertile women with effective contraceptive methods)
- •Progressive MS since at least three years
- •Some kind of documented progression of neurological symptoms during the previous two years.
- •Expanded Disability Status Scale (EDSS) 4,0 - 7.0 (inclusive) (basically spared arm functions)
- •Conventional therapy not indicated, contraindicated or failed
- •Judged as compliant with the protocol
排除标准
- •Eligible for any of the conventional MS therapies
- •Relapsing remitting multiple sclerosis (RRMS)
- •Bleeding diathesis or medication contraindicating neurosurgical procedures or lumbar puncture
- •Cognitive defect making informed consent unreliable
- •Any medical condition contraindicating minor surgical procedures, as judged by anaesthesiologist
- •Severe, uncontrolled heart disease
- •Pregnant or lactating women
- •Patients having contraindication for or otherwise not compliant with MRI investigations
- •Documented vulnerability to infections
- •Simultaneous treatment with other immunosuppressive drugs
- •Documented allergy or intolerance to Rituximab
- •Severe psychiatric condition
研究组 & 干预措施
Rituximab
Rituximab, 25 mg, is administrated intrathecal three times one week apart
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: One year after completed treatment
Feasibility of IT administered monoclonal antibodies
次要结局
- Stabilisation of the neurological deterioration(At 3,6,9,12 month after completed treatment)
研究者
Anders Svenningsson
MD, PhD, Assoc Prof
Umeå University