Clinical Trial of Perispinal Etanercept Treatment for Stroke patients to examine the effect on fatigue and muscle spasticity.

Phase 1

Completed

• Conditions: Stroke; Fatigue; Muscle Spasticity; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12620000912987
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-14
• Study Completion: 2022-10-06
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified