ACTRN12620000912987已完成1 期
Placebo-controlled randomized Clinical Trial of Perispinal Etanercept in Australian patients with chronic stroke 2020: Fatigue & muscle spasticity study (PSE-2020).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 81
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •1)Stroke that occurred at least 6 months and not more than 15 years prior to screening for this study;
- •2)Haemorrhagic or ischemic stroke affecting mobility
- •3)Fatigue Assessment Scale (FAS) score of at least 30 out of 50.
- •4)Moderate muscle spasticity of the affected arm, with limited range of motion.
- •5)Participant is able to ambulate at least 5 meters (with or without a cane or walker) without assistance from another individual.
排除标准
- •1)Aphasia (inability to communicate during testing).
- •2)Dementia diagnosis prior to date of stroke
- •3)More than one stroke in the past 3 years
- •4)Parkinson’s Disease or Parkinsonian symptoms
- •5)Dementia with Lewy bodies
- •6)Multiple sclerosis at present or in the past
- •7)Demyelinating disease at present or in the past
- •8)History of tuberculosis
- •9)Positive PPD test or IFN gamma test.
- •10)HIV infection
- •11)History of hepatitis B
- •12)History of deep fungal infection (coccidiodomycosis, histoplasmosis, blastomycosis)
- •13)Active infection
- •14)Indwelling urinary catheter
- •15)Lymphoma, active or in the past
- •16)Cancer within the past 5 years, non-melanoma skin cancer excluded
- •17)History of Malignant Melanoma
- •18)Uncontrolled diabetes mellitus
- •19)Participants using any immunosuppressive medication, including Kineret (Anakinra) or Abatacept, or glucocorticoids currently
- •20)Use of a TNF inhibitor (etanercept, infliximab, etc.) in the past
- •21)Congestive Heart Failure
- •22)Non-ambulatory
- •23)Less than two months since hospitalization for any cause
- •24)Pregnancy or breast-feeding
- •25)Psychosis or use of anti-psychotic medication (e.g. olanzapine, quetiapine, clozapine, aripiprazole, haloperidol, flupenazine, risperidone, ziprasidone)
- •26)History of Alcohol abuse within 1 year of study entry
- •27)Autoimmune disorder
- •28)Previous neck surgery (such as cervical fusion)
- •29)Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, or coronary disease), or chronic condition (e.g., psychiatric disorder), which, in the opinion of the investigator, would affect the assessment of the safety and tolerability of perispinal Etanercept.
- •30)Severe aphasia.
- •31)Participant is not using anti-coagulant (e.g. warfarin, etc.) or anti-platelet drug treatment (e.g. aspirin, etc.) to reduce the risk of ischemic stroke.
- •32)BMI greater than 40.
- •33)Grand mal seizure within 3 months of study enrolment.
- •34)Participant has received any investigational drug within 30d before screening, or is scheduled to receive an investigational drug, other than the blinded-study drug during the course of this study.
研究者
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