None listed
Conditions
Brief summary
The participant is invited to take part in this research project. This is because the participant has had a stroke within the last 15 years and has ongoing disability and impairments. The research project is testing a new treatment for stroke called Etanercept. Stroke survivors often have lifelong, disabling effects as a result of their stroke which impact daily life. Because current treatment options for post-stroke impairments are limited, stroke survivors sometimes try out therapies that may not be scientifically proven. The use of Etanercept injected at the base of the neck, is one treatment that has received a lot of attention in the media as it has been linked with improvement of stroke symptoms. It is unclear whether these improvements are due to the drug or other factors, as many of the effects have been seen in small observational case studies. Etanercept is approved in Australia to treat joint conditions (such as rheumatoid arthritis) or skin conditions (such as psoriasis). However, it is not approved to treat stroke. Therefore, it is an experimental treatment for stroke. This means that it must be tested to see if it is an effective treatment for stroke. This trial is aiming to properly test to see whether this medication is an effective treatment. The participant will be randomly assigned to receive an injection of Etanercept or an injection of a placebo at two timepoints in the study. The study will be double-blinded. This means that neither you, the participant nor their study doctor will know which treatment they are receiving. However, the study doctor can find out which treatment they are receiving if necessary, for safety reasons.
Interventions
The participant will be randomised to receive two injections subcutaneously of Etanercept (25mg) 4 weeks apart (baseline and follow-up visit 1) in the study.
Sponsors
The Florey Institute of Neuroscience and Mental Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed