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临床试验/NCT06033846
NCT06033846已完成2 期

Efficacy and Safety of Adjunctive Minocycline in the Treatment of Autoimmune Encephalitis: Open-lable, Randomised, Proof of Concept Study

Xijing Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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)

研究者

发起方
Xijing Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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