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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
7/10/2020
Date data sharing statement initially provided
7/10/2020
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
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.
Secondary ID [1] 299393 0
None
Universal Trial Number (UTN)
U1111-1240-9325
Trial acronym
PESTO
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
acute ischemic stroke 314565 0
hemorrhagic stroke 318202 0
Condition category
Condition code
Stroke 312903 312903 0 0
Ischaemic
Stroke 312905 312905 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 317856 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 324169 0
The proportion of patients at day 28 with a change in overall quality of life score as measured using the SF-36 questionnaire.
Timepoint [1] 324169 0
Assessment will be made at baseline and at Day 28 post-first dose (follow-up visit 1).
Secondary outcome [1] 383911 0
The proportion of patients at day 56 with a change in overall quality of life score as measured using the SF-36 questionnaire.
Timepoint [1] 383911 0
Assessment will be made at Day 56 post-second dose (visit 4).

Eligibility
Key inclusion criteria
1. Patients with a history of acute ischemic or hemorrhagic stroke confirmed on imaging
2. Age 18 years to 65 years at time of stroke
3. Moderate-to-severe disability resulting from stroke as defined by a modified Rankin scale of 3-5
4. Stroke occurred between 1 and 5 years before enrollment.
5. SF-36 score less than 95
6. 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
7. Consent can be obtained from the participant or person responsible
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint(s)
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16924 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 16925 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 30582 0
3084 - Heidelberg
Recruitment postcode(s) [2] 30583 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 22679 0
United Kingdom
State/province [1] 22679 0
Nottingham
Country [2] 22958 0
New Zealand
State/province [2] 22958 0
Christchurch

Funding & Sponsors
Funding source category [1] 303902 0
Charities/Societies/Foundations
Name [1] 303902 0
Stroke Foundation
Address [1] 303902 0
Level 7/461 Bourke St,
Melbourne VIC 3000
Country [1] 303902 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Florey Institute of Neuroscience and Mental Health
Address
245 Burgundy Street
Heidelberg Victoria 3084
Australia
Country
Australia
Secondary sponsor category [1] 304050 0
None
Name [1] 304050 0
NA
Address [1] 304050 0
NA
Country [1] 304050 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304408 0
Austin Health
Ethics committee address [1] 304408 0
145 Studley road
PO Box 555 Heidelberg
VIC Australia 3084
Ethics committee country [1] 304408 0
Australia
Date submitted for ethics approval [1] 304408 0
Approval date [1] 304408 0
05/09/2019
Ethics approval number [1] 304408 0

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 5 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.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96846 0
Prof Vincent Thijs
Address 96846 0
Austin Health
Department of Neurology
145 Studley Road
Heidelberg Victoria 3084
Country 96846 0
Australia
Phone 96846 0
+61 3 9496 4824
Fax 96846 0
Email 96846 0
Vincent.THIJS@austin.org.au
Contact person for public queries
Name 96847 0
Ms Sooma Jafari
Address 96847 0
The Florey Institute of Neuroscience & Mental Health
245 Burgundy Street
Heidelberg Victoria 3084


Country 96847 0
Australia
Phone 96847 0
+61 3 9035 7273
Fax 96847 0
Email 96847 0
PESTO@florey.edu.au
Contact person for scientific queries
Name 96848 0
Ms Sooma Jafari
Address 96848 0
The Florey Institute of Neuroscience & Mental Health
245 Burgundy Street
Heidelberg Victoria 3084

Country 96848 0
Australia
Phone 96848 0
+61 3 9035 7273
Fax 96848 0
Email 96848 0
PESTO@florey.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results