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