Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Montreal-Cognitive Assessment (MoCA)scores
研究概览
简要总结
Autoimmune encephalitis (AE) is an immune-mediated brain disorder characterized by varied clinical manifestations that correlate with specific types of antibodies.Typical symptoms include acute behavioral changes, psychosis, seizures, memory deficits, dyskinesias, speech impairments, and autonomic and respiratory dysregulation.While the majority of patients respond well to immunotherapeutic agents, a significant proportion remains resistant to initial and secondary-line immunotherapies.Minocycline, a semisynthetic tetracycline, is notably used for the central nervous system due to its lipophilic characteristics and its capacity to penetrate the blood-brain barrier. While the primary neuroprotective focus of minocycline in the central nervous system remains unknown, the primary effects of minocycline include the inhibition of microglial activation, mitigation of apoptosis, and reduction in reactive oxygen species generation.Protective effect has been observed in hypoxic injury, ischemic stroke, amyotrophic lateral sclerosis, traumatic spinal cord injury, multiple sclerosis, Parkinson's disease, and Huntington's disease.Can minocycline offer a protective role in AE? Consequently, we proposed a randomized, controlled trial to investigate the efficacy of minocycline in AE.
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
- None
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
- •Diagnosis of definite autoimmune encephalitis(Graus et al 2016.)
- •Age ≥ 18 years
- •Acute or subacute onset (rapid progression of less than 3 months)
- •Reasonable exclusion of alternative causes
- •Written informed consent
排除标准
- •Known allergy to tetracycline antibiotics.
- •Pregnant women.
- •Uncontrolled serious concomitant illness.
- •Known chronic kidney disease stages 3b-
- •Moderate liver disease (see Child-Pugh for Classification of Severity of Liver Disease).
- •history of cognitive impairment
研究组 & 干预措施
Experimental: Treatment group
Drug: Minocyclin 200 mg oral minocycline for a total of 30 days
干预措施: Minocycline (Drug)
结局指标
主要结局
Montreal-Cognitive Assessment (MoCA)scores
时间窗: 3 months
the change in MoCA scores from baseline to 3 months
次要结局
- mini-mental state examination (MMSE) scores(from baseline to months 1, 3, 6, and 12)
- modified rankin scale (mRS) scores(1 month)
- MoCA scores(from baseline to months 1, 6, and 12)
- Hamilton anxiety scale (HAMA) scores(from baseline to months 1, 3, 6, and 12)
- Hamilton depression scale (HAMD) scores(from baseline to months 1, 3, 6, and 12)
