- PLATYPUS marks an important step forward for people living with progressive MS, an area of significant treatment need.
- The adaptive clinical trial design is a new way of performing clinical trials which is more flexible, efficient and timely than traditional methods.
- Following on from the OCTOPUS clinical trial, which commenced in the UK in 2023, Australia will be the first international site added to the study.
In 2023, an exciting new adaptive clinical trial called OCTOPUS commenced in the United Kingdom (UK) for both secondary progressive MS (SPMS) and primary progressive MS (PPMS), together called progressive MS (PMS).
The trial is investigating several promising medications to see if they can delay disease progression in PMS. The study will be replicated for Australia as PLATYPUS, using the same protocol, assessments and medications as in the UK OCTOPUS study. Approximately 1600 people with PMS will be enrolled in the studies over the next five years.
What is an adaptive clinical trial?
An adaptive clinical trial (ACT) uses a new design whereby interim examinations of the accumulating study data occur as the trial progresses, rather than the traditional way of waiting until the end of the study. By doing this, changes can be made to the trial in real-time, such as changes to doses, adding new medications or dropping medications that don’t seem to be working as well.
Making these changes as the study progresses is more cost-effective and time-efficient, and in MS, time represents saving brain and spinal cord tissue. Additionally, if a medication is found to be inferior during the course of an ACT, that medication can be discontinued early from the trial, and participants may then have opportunities to be allocated to alternative trial treatments showing more promise, thereby maximising brain health.
Bringing adaptive clinical trials to Australia has been a major goal for MS Australia, and we are delighted to support the first Australian adaptive clinical trial in progressive MS.
What makes PLATYPUS different to what we have seen before?
The medications to be trialled in the PLATYPUS study are repurposed medications. These are medications that are already approved for use in other conditions. Having prior knowledge of the safety and side effect profile of these medications saves many years of research, shaving much-needed time off the clinical trial process.
A team of expert scientists and clinicians have profiled a list of medications that potentially have properties to repair myelin (remyelination) and protect the nerves (neuroprotection). These medications will form the basis of investigation in PLATYPUS, starting with two medications and comparing them against a placebo (dummy or inactive medication).
Over time, the interim examinations of the data will demonstrate to the investigators which medications are performing well and which are not. Medications from the planned list of potential medications can then be dropped or added to the trial as time goes on.
It is anticipated that the trial will run for five years so that the progression of disability over that time can be measured and assessed. Additionally, people with MS have been extensively consulted throughout the trial design stages, both in Australia and the UK.
Who can participate?
As with all clinical trials, there are strict eligibility criteria that must be met to take part.
For PLATYPUS, participants must be diagnosed with SPMS or PPMS, be aged 25-70 years, have an expanded disability status scale (EDSS) between 4.0 and 8.0 and meet certain other inclusion and exclusion criteria around co-existing conditions, pregnancy, medications and treatments.
This more detailed information will be provided after regulatory approvals are in place for Australia.
How can I find out more information?
The clinical trial process requires significant applications to ethics, governance and regulatory authorities for approval. When these approvals are all met, study sites in Australia may start recruiting people living with MS into the PLATYPUS clinical trial.
The MS Australia and MSWA websites will have the information you need to progress your interest in the trial. Also, keep an eye on social media posts from both MS Australia and MSWA during 2024 for the latest updates.
When the time comes to commence the study in Australia, your neurologist and MS care team will also be an important source of information about PLATYPUS. Stay tuned during this exciting time for collaborative international research to make significant advances in treating and monitoring progressive MS.
