ACTRN12615001377527招募中1 期
Phase I/II clinical trial of Perispinal Etanercept in Australian patients with Chronic Stroke.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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
- 30 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Chronic neurological impairment, including hemiparesis, following stroke that occurred at least 6 months and not more than 10 years prior to screening for this study.
- •2. A previous ischemic or hemorragic stroke in 1). the territory of the right or left middle cerebral artery (MCA); or 2). subarachnoid hemorrhage.
- •3. Age between 30-80. Age at 80 maximum to avoid possible morbidity on trial.
- •4. Stroke-induced cognitive impairment by history (difficulty with memory or cognition). The chronic stroke is associated with severe cognitive impairment and assessment of cognitive function by MMSE score is 16-25, or Montreal Cognitive Assessment (MOCA) score is measured in the range of 12-24, inclusive performed upon assessment during enrolment.
- •5. Individual has walking impairment but is ambulatory (with or without a quad cane or single point cane or walker) without assistance from another individual.
- •6. Chronic and intractable neuropathic pain due to stroke with pain score between 4 to 8 inclusive on the vertical assessment score.
排除标准
- •1. Dementia or cognitive impairment prior to date of stroke
- •2. Brain stem stroke
- •3. More than one stroke in the past 3 years
- •4. Pain score of less than 4 or above 8 out of 10 on the vertical assessment scale (VAS)
- •5. Parkinson’s Disease or Parkinsonian symptoms
- •6. Dementia with Lewy bodies
- •7. Multiple sclerosis
- •8. Demyelinating disease
- •9. History of tuberculosis
- •10. Positive PPD
- •11. HIV infection
- •12. History of hepatitis
- •13. History of deep fungal infection (coccidiodomycosis, histoplasmosis, blastomycosis)
- •14. Active infection
- •15. Indwelling urinary catheter
- •16. Lymphoma, active or in the past
- •17. Cancer
- •18. Uncontrolled diabetes mellitus
- •19. Patients using any other immunosuppressive medication, including Kineret (Anakinra) or Abatacept, or glucocorticoids.
- •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
- •25. Psychosis or use of anti-psychotic medication (e.g. olanzapine, quetiapine, clozapine, aripiprazole, haloperidol, flupenazine, risperidone, ziprasidone)
- •26. History of Alcohol abuse
- •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. Not taking an anticoagulant or an anti-platelet drug
- •31. No severe aphasia, as investigators need to be able to converse with the patients from the outset to reasonably assess their medical condition.
研究者
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