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

Phase 2

• Conditions: acute ischemic stroke; hemorrhagic stroke; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12620001011976
• Lead Sponsor: The Florey Institute of Neuroscience and Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-07
• Study Completion: 2023-11-24
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients at day 28 with a change in overall quality of life score as measured using the SF-36 questionnaire.[ Assessment will be made at baseline and at Day 28 post-first dose (follow-up visit 1).<br>]

Secondary Outcome Measures

Name	Time	Method
The proportion of patients at day 56 with a change in overall quality of life score as measured using the SF-36 questionnaire.[ Assessment will be made at Day 56 post-second dose (visit 4).]