Chronic stroke remains a major health challenge in Australia and worldwide
It’s Australia's second largest cause of death, with one person suffering from the disease every 10 minutes.
An experimental treatment in the US is giving some stroke patients immediate relief from the crippling disease. Griffith University has recently undergone a clinical trial to examine this potential treatment.
The US Federal Drug Administration has approved Etanercept (Enbrel) for many years as a therapy to treat inflammatory diseases such as rheumatoid arthritis. Recently, doctors have begun using the drug to treat strokes. A clinical trial is currently being planned at Griffith University that will investigate the effectiveness of Enbrel treatment in stroke patients, with the aim of gaining national approval.
We would like to thank you for your continued patience whilst we have been busy analysing the data, results and outcomes from the Griffith University Stroke Trial. We then went through the difficult process of submitting the trial results for peer review and final publication. This took several months of solid work, however, the trial's outcomes and findings were recently accepted and published on Taylor & Francis Online.
- Perispinal etanercept showed a significant effect with a decrease in pain levels by 20-30 points out of 100. Three out of these 10 participants no longer experienced any pain after their first and second treatments.
- Perispinal etanercept showed an improvement in mobility in 9 out of 10 participants who received this therapy. Many of these showed complete recovery of their 180 degrees in shoulder flexion (sitting with the affected arm at the side and then raising this arm above the shoulder level in front, to above the head).
- Other positive effects were noted that were not tested such as improved leg motion, relaxation of the restricted muscles, improved sense of smell and generally improved mobility.
- No significant effects were detected in the control group, who received saline treatments during the trial. However, many of these participants after the trial who then elected to have the perispinal etanercept therapy as open-label did show improvements.
The trial investigators would like to take this opportunity to thank all of our participants for their crucial involvement in the trial. Unfortunately, due to copyright restrictions, a full copy of the publication can not be released at this stage, however, the abstract is available via the Journal's website and can be accessed here.
In due course, a draft version of the publication will become available on our Griffith University Stroke Trial website for those who would like to read about the results in more detail.
We are currently aiming to begin our next stroke trial around March 2020. Unlike our first trial, this study will not be focussed on daily pain and will be open to a wider range of stroke patients.
If you are interested in participating in the next trial and have not previously had the treatment, please send an email with your details to: firstname.lastname@example.org.
You will be advised by return email once the trial is approved. Invitations will then be sent out requesting trial applications be completed and returned in the next several months.
Again, we wish to thank you for your patience and understanding as the Stroke Trial Team embarks on the next important phase of our research.
Please note the stroke trial is now closed for enrolment. The trial will continue throughout 2019 with outcomes expected to be released in approximately 12 months.
There are very specific inclusion criteria to be involved in this trial, please contact us if you fit the following three points for possible inclusion:
- aged between 30-80 years old
- the stroke that occurred must be at least 6 months and not more than 15 years prior to screening for this study
- chronic neurological impairment, including left hemiparesis, following an ischemic stroke in the territory of the right middle cerebral artery (rMCA) (may include rMCA clot or embolus or right carotid occlusion causing rMCA territory stroke) or right basal ganglia form of intracerebral haemorrhage.
We have been busy undergoing extensive preparations required to run a trial of this scale. Most of last year (2016) involved critical assessment of our clinical trial protocol, which was extensively reviewed by the Australian Stroke Trials Network. The team provided us with valuable suggestions and instructed us to overhaul and revise our study protocol to streamline and improve it. Although this has caused considerable delays, it will be highly beneficial for the outcomes of the study. These revisions have now been carried out and ethical approvals have been re-obtained.
We have also been actively engaged in finalising the trial funding arrangements with the Stroke Trial Recovery Fund, who will be helping support the trial.
The specialised equipment required for the trial has now arrived and we are currently recruiting more local neurologists from regional Gold Coast hospitals to participate as clinical investigators. Once we have finalised the appointment of neurologists and held the induction training for the clinical team, the trial is expected to begin. A further update will be provided at that time. We thank everyone for their continued patience.
Chronic Stroke Treatment
Ethical and regulatory approvals have been granted, and the clinical trial will initially be carried out with a small group of 20 patients. The number of participants needed may increase as the trial progresses.
Expressions of interest are welcome.
Location and postal address
Griffith University Stroke Trial
School of Medical Science
Southport, Qld 4222