A Prospective multicentre, phase 2b randomised controlled double-blind trial, to determine the safety and efficacy of perispinal etanercept on quality of life at 28 days post treatment in stroke survivors.

The Florey Institute of Neuroscience and Mental Health0 个研究点目标入组 126 人开始时间: 2020年10月7日最近更新: 2024年5月21日

试验速览

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•1. Patients with a history of acute ischemic or hemorrhagic stroke confirmed on imaging
•2. Age 18 years to 70 years at time of stroke, or age 16 or 17 but patient is currently 18 years or older
•3. Moderate-to-severe disability resulting from stroke as defined by a modified Rankin scale of 3-5 or with SF-36 total score of <80
•4. Stroke occurred between 1 and 15 years before enrollment.
•5. At time of enrolment, the patient is less than or equal to 70 years
•6. SF-36 score less than 95 or <80 if mRS =2
•7. Patient is able to complete the SF-36 questionnaire independently or availability of a relative or carer who is able to complete the SF-36 questionnaire on behalf of the patient
•8. Consent can be obtained from the participant or person responsible

•1. Contra-indication to etanercept (eg previous hypersensitivity, ongoing infection, use of IL-1 antagonists)
•2. History of hepatitis B and C, tuberculosis, HIV, SLE, multiple sclerosis, moderate to severe heart failure
•3. History of malignancy
•4. Other use of immunosuppressant
•5. Clinical diagnosis of dementia
•6. mRS 0-2 unless SF-36 total score is below 80
•7. Botulinum toxin injection to limbs in the 4 months prior to Screening Visit
•8. Pregnancy (women of childbearing potential must be tested)
•9. Breastfeeding
•10. Participation in any investigational study in the last 30 days
•11. Known terminal illness or planned withdrawal of care or comfort care measures.
•12. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
•13. Prior exposure to etanercept for stroke

发起方