Possible Immuno-Modulatory Effect of Tocilizumab in Patients With Refractory Status Epilepticus.
试验速览
- 阶段
- 3 期
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB )
研究概览
简要总结
Recently, the pathogenesis of epilepsy is immuno-modulatory and neuro-inflammatory which is commonly activated in epileptogenic brain regions in humans and is clearly involved in animal models of epilepsy. Inflammatory mediators in the blood and molecular imaging of neuro-inflammation could provide diagnostic, prognostic, and predictive biomarkers for epilepsy, which will be instrumental for patient stratification in future clinical studies. Dysfunction of the blood-brain barrier (BBB) may be responsible for abnormal neuronal firing. Disruption of the BBB causes the leakage of serum protein and leucocyte invasion into the brain. These exogenous inflammatory mediators have the potential to lower seizure thresholds, which could alter channel sensitivity, neurotransmitter uptake or release, and glia-associated regulation of extracellular environments, such as potassium concentration.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind
入排标准
- 年龄范围
- 15 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 15-75 years old.
- •Gender: Male and female.
- •Newly diagnosed refractory status epilepticus patients who are scheduled to receive anti-epileptic drugs.
- •Patients with normal renal and hematological functions.
排除标准
- •Old age >75 years old.
- •Pregnant or lactating females.
- •Severe renal impairment when GFR<30 ml/min.
- •Hepatic patients ( not recommended with active hepatic disease or hepatic impairment specially when ALT or AST >3 times ULN).
- •Neutropenia when neutrophil count <500 cells/mm3 due to increase the risk of infection.
- •Thrombocytopenia when platelet count < 50000 cells/mm
- •Patients take Immunosuppressant drugs.
- •Cancer patient who taking chemotherapy.
- •Patients with a known hypersensitivity to any of the used drugs.
研究组 & 干预措施
Control Group
Group 1 received the conventional treatment for Status Epilepticus including propofol (loading dose is 3 to 5 mg/kg with maintenance of 1 to 15 mg/kg/h), phenobarbital (initial loading dose is 5 to 15 mg/kg over 1 hour. Infusion rates can be maintained at 0.5 to 15 mg/kg/h), and midazolam (a loading dose of 0.2 mg/kg is given with maintenance doses ranging between 0.05 and 2.0 mg/kg/h).
干预措施: Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam (Drug)
Tocilizumab Group
Group 2 received the same treatment in group 1 in addition to tocilizumab that was initiated at a dose of 4mg/kg administered twice monthly with 1-week intervals for 3 months. A monthly dose (8mg/kg) of tocilizumab was added if needed.
干预措施: Tocilizumab Prefilled Syringe [Actemra]. propofole, phenobarbital, midazolam (Drug)
结局指标
主要结局
change in the level of inflammatory biomarkers (IL-6, TNF-alpha, IL-1β and NF-κB )
时间窗: 3 months
次要结局
未报告次要终点