A clinical trial into improving mobility and pain relief in stroke sufferers found one-third of participants saw immediate and complete loss of pain and the majority experienced significant improvements in their movement.
The Griffith University-led human clinical trial showed significant pain alleviation and improved mobility of the stroke affected arm in the drug treated group of stroke sufferers, but not the control group of the trial.
The researchers used perispinal etanercept (PSE). Etanercept is a drug commonly used to treat rheumatoid disorders such as arthritis and was repurposed in the trial for stroke.
PSE provides unprecedented outcomes for improving conditions such as stroke-related disability and delays dementia progression, improving recovery from a range of neurological conditions.
Lead investigator Associate Professor Stephen Ralph from Griffith’s School of Medical Science said the findings from the peer-reviewed, double-blinded, placebo controlled, randomised clinical trial were unprecedented in terms of beneficial improvements that were provided in recovery of participants from stroke-related disability.
The study enrolled 26 patients (22 completed the study) that were on average 4 to 5 years out from their stroke.
“In nearly one-third of patients who experienced constant pain on our trial that would not respond to other medications, we saw a rapid and complete loss of pain straight away, after receiving PSE therapy,” Associate Professor Ralph said.
“These findings support the published observations from animal models of stroke, prior case studies and open-label/observational studies on over a thousand stroke patients reported previously.
“Many examples of the benefit to stroke patients are available to watch online at the Institute of Neurological Recovery website.
“The evidence is now overwhelmingly in favour that PSE treatment can benefit many individuals with stroke disability.”
Perispinal etanercept is a major game changer for medicine and the treatment of a range of neurological diseases including dementia, stroke, TBI’s and others.
Perispinal delivery bypasses the blood-brain barrier allowing simple, efficient access of large drugs delivered to the brain.
Associate Professor Ralph said the next step would be to undertake a larger, more open study of stroke patients in general. The first trial was focused on pain as the primary outcome measure. However, he said the finding of improved mobility was very promising and would be a main focus of the second, larger trial to be run in 2020.
The results have been published in the journal Expert Opinion on Investigational Drugs.
The investigators acknowledge the support of all patients who participated in this study. Also, they thank Dr Coralie Graham, Director, SRTF for support. The support of Dr Ed Tobinick for training in perispinal delivery and input into the design of the study protocol for the trial is also acknowledged. No pharmaceutical companies were involved with this trial.
Declaration of interest
The authors have no other relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.