None listed
Conditions
Brief summary
1 in 6 Australians will have a stroke. Other than acute and supportive rehabilitative care – there is no effective treatment for chronic stroke. When brain tissue is damaged, the area around the dead area undergoes a long-term neuro-inflammatory process effectively shutting down the function of the area and extending the originally damaged area. By injecting an anti-inflammatory biologic medication currently used to treat Rheumatoid arthritis by a novel route to bypass the blood brain barrier with 2 doses, 2 weeks apart, it is proposed that this neuroinflammation will be reduced and some associated function regained. PSE 2020 will extend on the data from a recently published world-first RCT conducted by Griffith University School of Medical Science.
Interventions
Pre-clinical trial screening of participants using Fatigue Assessment Scale (FAS) to select participants who meet the inclusion criteria of FAS >= 35/50 and to establish a baseline SF36 score. Shoulder goniometry will be conducted on the first treatment day.
Intervention drug - Etanercept
Dose Administered: 25 mg
Total duration and frequency of administration, e.g. two doses administered 10-15 days apart;
Mode of administration : Subcutaneous Injection(dorsally above the spine).
Total study
Pre-clinical trial screening of participants using Fatigue Assessment Scale (FAS) to select participants who meet the inclusion criteria of FAS >= 35/50 and to establish a baseline SF36 score. Shoulder goniometry will be conducted on the first treatment day. Intervention drug - Etanercept Dose Administered: 25 mg Total duration and frequency of administration, e.g. two doses administered 10-15 days apart; Mode of administration : Subcutaneous Injection(dorsally above the spine). Total study duration (including run in screening period): 42 days
Sponsors
Griffith University
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) 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.
Exclusion criteria
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.
Outcome results
None listed