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Trial registered on ANZCTR
Registration number
ACTRN12620001011976
Ethics application status
Approved
Date submitted
18/06/2020
Date registered
7/10/2020
Date last updated
15/05/2024
Date data sharing statement initially provided
7/10/2020
Date results information initially provided
15/05/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
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
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Scientific title
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 in stroke survivors.
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Secondary ID [1]
299393
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None
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Universal Trial Number (UTN)
U1111-1240-9325
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Trial acronym
PESTO
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Linked study record
NA
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Health condition
Health condition(s) or problem(s) studied:
acute ischemic stroke
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hemorrhagic stroke
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Condition category
Condition code
Stroke
312903
312903
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0
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Ischaemic
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Stroke
312905
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0
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Haemorrhagic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
317856
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Treatment: Drugs
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Comparator / control treatment
The participant will be randomly assigned to receive two injections subcutaneously of normal saline (25mg) 4 weeks apart (baseline and follow-up visit 1) in the study.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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The proportion of patients at day 28 with a change in overall quality of life score as measured using the SF-36 questionnaire.
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Assessment method [1]
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Timepoint [1]
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Assessment will be made at baseline and at Day 28 post-first dose (follow-up visit 1).
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Secondary outcome [1]
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The proportion of patients at day 56 with a change in overall quality of life score as measured using the SF-36 questionnaire.
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Assessment method [1]
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Timepoint [1]
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Assessment will be made at Day 56 post-second dose (visit 4).
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The primary endpoint, an achievement of at least 5 points improvement on the SF-36 score will be tested using a logistic regression model with the treatment arms as an independent variable and baseline value of SF-36, proxy or self- administration of SF-36 as adjustment covariates.
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
6/11/2020
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Actual
6/11/2020
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Date of last participant enrolment
Anticipated
30/04/2022
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Actual
6/09/2023
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Date of last data collection
Anticipated
28/06/2022
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Actual
24/11/2023
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Sample size
Target
168
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Accrual to date
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Final
126
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment hospital [2]
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The Alfred - Melbourne
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Recruitment postcode(s) [1]
30582
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3084 - Heidelberg
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Recruitment postcode(s) [2]
30583
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3004 - Melbourne
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Recruitment outside Australia
Country [1]
22958
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New Zealand
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State/province [1]
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Christchurch
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Stroke Foundation
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Address [1]
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Level 7/461 Bourke St,
Melbourne VIC 3000
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Country [1]
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Australia
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Funding source category [2]
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Government body
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Name [2]
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Medical Research Future Fund
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Address [2]
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Country [2]
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
The Florey Institute of Neuroscience and Mental Health
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Address
245 Burgundy Street
Heidelberg Victoria 3084
Australia
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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NA
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Address [1]
304050
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NA
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Country [1]
304050
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Austin Health
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Ethics committee address [1]
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145 Studley road
PO Box 555 Heidelberg
VIC Australia 3084
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
304408
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Approval date [1]
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05/09/2019
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Ethics approval number [1]
304408
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Summary
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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Vincent Thijs
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Address
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Austin Health
Department of Neurology
145 Studley Road
Heidelberg Victoria 3084
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Country
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Australia
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Phone
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+61 3 9496 4824
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Nerida Larkin
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Address
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The Florey Institute of Neuroscience & Mental Health
245 Burgundy Street
Heidelberg Victoria 3084
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Country
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Australia
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Phone
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+61 3 9035 7273
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ms Vincent Thijs
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Address
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The Florey Institute of Neuroscience & Mental Health
245 Burgundy Street
Heidelberg Victoria 3084
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Country
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Australia
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Phone
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+61 3 9035 7273
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Fax
96848
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Email
96848
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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