Florey Institute of Neuroscience and Mental Health
Stroke Theme
Professor Vincent Thijs graduated from the University of Leuven, Belgium in 1995 and completed his neurology training at the University Hospitals in Leuven and at the Stanford Stroke Center in California. He led the Stroke unit at the University Hospitals in Leuven until 2015 when he migrated to Australia. He is the Head of Stroke at the Austin Hospital and also consults via the Victorian Stroke Telemedicine Program. He completed a Phd in Biomedical Sciences in 2004 on stroke imaging. He is the co-head of the Stroke Theme at the Florey Institute of Neuroscience and Mental Health.

Presenter Of 1 Presentation

ONGOING CLINICAL TRIAL: A PROSPECTIVE MULTICENTRE, PHASE 2B RANDOMISED, CONTROLLED DOUBLE-BLIND TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF PERISPINAL ETANERCEPT ON QUALITY OF LIFE

Session Type
Oral Presentations
Date
27.10.2021, Wednesday
Session Time
08:00 - 08:50
Room
ORAL PRESENTATIONS 1
Lecture Time
08:20 - 08:30

Abstract

Background and Aims

There are few treatment options for stroke survivors with ongoing impairments. Recently, the beneficial effects of a tumor necrosis factor inhibitor, etanercept, has caught the attention of the media and the stroke survivor community. Observational, uncontrolled studies suggest substantial improvements of chronic impairments after a single administration of etanercept, injected subcutaneously in the perispinal region. Large, randomized controlled trials have not been conducted.

Methods

The Perispinal Etanercept for STroke Outcomes trial (ACTRN12620001011976) is a 30-months, phase 2b, multicenter, randomized, double blind, placebo-controlled trial testing the safety and efficacy of administration of perispinal etanercept in improving patient reported outcomes at 28 days after treatment. The required sample size is 168. Eligible patients are aged ≤65 years at time of stroke, between 1-5 year after the index stroke, with a current modified Rankin scale of 3 to 5. The primary efficacy hypothesis is that treatment with perispinal etanercept improves quality of life in stroke survivors, as measured with the Short Form-36. The secondary hypothesis is that repeated injection of etanercept leads to improved quality of life compared to a single injection. Other exploratory outcome measures include the NIHSS, MOCA, FIM, modified Rankin scale, pain VAS, FAS, PHQ-9, GAD-7.

Results

The trial is ongoing with 36 patients enrolled as of May 14 2021 at sites in Australia and New Zealand.

Conclusions

The promise of etanercept to improve quality of life in chronic stroke survivors needs to be tested. PESTO will inform the stroke community about the efficacy and safety of this intervention.

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