Perispinal Etanercept therapy in Australian patients with chronic stroke.

Phase 1

Recruiting

• Conditions: Chronic Stroke; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12615001377527
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-17
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified