Chronic stroke remains a major unmet health problem in Australia and worldwide. Currently, no approved medical therapies have been shown to improve the long-term clinical deterioration caused by this condition when patients do not respond further to current rehabilitative therapies.
Etanercept (ENBREL) has been approved by the US Federal Drug Administration for many years as a therapy to treat inflammatory diseases such as rheumatoid arthritis. This drug has a well-characterised safety profile for these uses and is approved for such use in Australia. Recently, researchers in the US have started investigating the usefulness of this drug in treating stroke. Similar research is also being planned by Griffith University researchers.
The Griffith University Stroke Clinical Trial is currently undergoing modifications to focus on a particular group of stroke patients with anatomically well-defined problems and clinical characteristics - namely those who have right hemisphere stroke with left sided hemiparesis (weakness of left arm and left leg). Patients who have had a stroke in the territory of the right middle cerebral artery (right MCA stroke) will be the focus. This type of stroke affects the left side of the body, causing left-sided weakness. The study is targeting these patients exclusively as they have characteristic neurological dysfunction that can be evaluated for a particular set of outcomes in a more straightforward manner, comparing before and after treatment. Thus, left hemiparesis will be a specific inclusion criteria for entry into the study.
- Chronic neurological impairment, including hemiparesis, following stroke that occurred at least 6 months and not more than 15 years prior to screening for this study.
- the territory of the right or left middle cerebral artery (MCA); or
- subarachnoid haemorrhage (bleeding in the area between the brain and the thin tissues that cover the brain).
- A previous ischemic or hemorrhagic stroke in
- Aged between 30-80.
- Stroke-induced cognitive impairment by history (difficulty with memory or cognition). The chronic stroke is associated with severe cognitive impairment and assessment of cognitive function by MMSE score is 16-24, or Montreal Cognitive Assessment (MOCA) score is measured in the range of 12-22. This assessment will also be performed during enrolment.
- Individual has walking impairment but is ambulatory (with or without a quad cane or single point cane or walker), without requiring assistance from another individual.
It is expected that the trial will commence in 2017. Recruitment of eligible trial participants has not yet begun. If you are an eligible candidate, please await further advice regarding application and recruitment processes that will be posted on this webpage.
We regret that we are unable to enrol candidates with other types of stroke into this trial. If you do not meet the entry criteria for this trial and are investigating perispinal etanercept treatment, please be aware that to our knowledge this is not available elsewhere in Australia. It is currently offered at the Institute for Neurological Recovery in Los Angeles and Miami, USA. We cannot give assurance that this method will receive regulatory approval in Australia. The Griffith University Stroke Clinical Trial is being designed to be able to contribute the most reliable data to facilitate that goal, in order to obtain national approval.
Clinical trial for the treatment of chronic stroke
Ethical and regulatory approvals have been granted, and the clinical trial will initially be carried out with only a small group of 20 patients. Successive groups may be required depending on the outcomes from the first group of 20.
It is important that we find out whether the results obtained with patients in the US can be reproduced here in Australia. Hence, the number of enrolling patients will be very limited in the early phase for the first several months, while the trial is underway.
Why this stroke treatment is not already freely available in Australia?
This treatment is based on a new application for an existing drug approved for the treatment of psoriasis and rheumatoid arthritis.
All those who wish to express their interest in this trial study and who have not already done so, please register via email to the address shown below. All updates on recruitment of participants will be posted on this webpage.
Griffith University Stroke Trial
c/- School of Medical Science
SOUTHPORT QLD 4222
Update - January 2017
Happy new year and greetings after the festive season. It has been some time since updating all those who expressed their interest in our trial. We have been busy undergoing the extensive preparations required to run such a trial. Most of last year (2016) involved critical assessment of our clinical trial protocol, which was extensively reviewed by the Australian Stroke Trials Network (http://astn.org.au/). They provided us with valuable suggestions and instructed us to overhaul and revise our study protocol to streamline and improve it. Although this has caused us considerable delays, it should prove highly beneficial for the outcomes of the study. The extensive revisions required many months. However, these revisions have now been carried out and ethics approvals re-obtained for the revised trial protocol.
We have also been actively engaged in finalizing the trial funding arrangements with the Stroke Trial Recovery Fund (www.strokerecoverytrialfund.org), who will be helping to support the trial.
We are presently in the process of recruiting more neurologists from the local Gold Coast regional hospitals to help participate in the trial as clinical investigators. The specialized equipment we require for the trial has arrived and is ready.
Once we have finalized the appointment of the neurologists, held the induction training for the clinical team, then the trial should start. A further update will be provided at that time and meanwhile, we thank everyone for their continued patience. We will be focusing only on Australian stroke patients residing in and around the Gold Coast region of Queensland, who can attend our trials unit for the several weeks required whilst they are enrolled on trial.
Update - February 2016
We are pleased to share further progress on the preparations for the Stroke Trial. In the last few months, we have recruited a clinical psychologist to join our team. We have also sourced and secured specialised equipment for measuring patient responses from overseas and look forward to receiving it shortly.
Our Stroke Trial is now going through an additional and final registration process to ensure we have the most suitable assessments in place for measuring rehabilitation.
We look forward to sharing more good news with you soon.Please refer to the website for updates and if you have not yet registered your interest in the trial and would like to do so, please email email@example.com
Update - October 2015We are pleased to share that all the trial preparations are nearing completion and we look forward to starting the trial in the next few months.
Researchers are in the final stages of reviewing the details of the occupational therapy rehabilitation tests with key industry experts to ensure the most effective assessments are in place to determine and measure accurately, the changes in participants who partake in the trial.
We thank you for your interest and appreciate that many of you are eagerly waiting a commencement date as we are. Please continue to refer to our website for updates.
Update - May 2015
We have had an overwhelming response to the Stroke research, which confirms the importance and need for such research. Thank you to everyone who has made contact and registered your interest.
Please be assured we are progressing research preparations as fast as possible and will keep you informed of any developments.
We would like to reiterate to please check this webpage for updates as they will be posted here in the first instance.
To those who have tried calling, please understand that we unfortunately do not have any further information at this stage. The next scheduled update is due to be emailed and posted on the webpage on 30 September 2015.