Clinical trials

UK ‘Octopus’ trial tackling multiple sclerosis is a world first

A ground breaking mega-trial for progressive multiple sclerosis will be launched in the UK later this year.

Octopus, so called because of its multiple arms, is a revolutionary clinical trial that will transform the way treatments for progressive MS are tested. It could deliver desperately needed new options up to three times faster.

Dr Emma Gray, assistant director of research at the MS Society, said: “More than 130,000 people live with MS in the UK and there are tens of thousands with progressive forms who have nothing to stop their MS getting worse. “But we believe we can stop MS, and the launch of Octopus is a crucial moment in our journey towards that goal.” Made possible by charity funding, Octopus will test several drugs – rather than just one – against a placebo at the same time. The trial will also combine what would normally be two consecutive trial phases into one. By bringing together lots of trials in this way, Octopus could rapidly speed up the development of new treatments. Prof. Olga Ciccarelli is a leading magnetic resonance imaging expert in the field of MS and has been instrumental in developing Octopus. “Octopus is a game changer for how MS clinical trials are run,” she said. “As well as testing many treatments at the same time with only one placebo arm, we’ll use an interim analysis of MRI scans to allow us to progress to the next stage much quicker.” If scans showed a treatment was slowing the rate of brain shrinkage, it could be assumed the pace of advancing disability would also slow down. The results would need to be investigated across hundreds of participants. “Any treatments not showing potential in the MRI analysis will be dropped, so we’re not wasting time or resource on treatments unlikely to be successful,” said Prof. Ciccarelli “Ultimately it’s a much more efficient trial and a major step forward in the search for progressive MS treatments.” The flexible approach also means the trial team can continually update Octopus as their knowledge evolves. If they discovered another effective treatment in the laboratory, that too could be quickly slotted in, rather than having to wait years to set up a whole new trial. Susan Scott, from Ashwell in Hertfordshire, was diagnosed with the relapsing form of MS in 2001. For over eight years she has been working with researchers and the MS Society to develop Octopus, representing the perspective of people living with MS. Susan said: “When I was diagnosed with MS there wasn’t much to treat my condition. But in twenty years there’s been an absolute explosion of treatments available to me. I want more people with progressive MS to have the same options I do.

“I know a young woman who, when I first met her, had just recently starting using a wheelchair. Within three years, she had no arm function or head support, and her voice had virtually gone. I feel passionately that we must work together to do something about this.” She said she had been very impressed with the in-depth patient representation on the Octopus trial. Patients had directly influenced how participants would receive information, including newsletters, social media and good old-fashioned mail.

Dr Emma Gray said: “Decades of research have got us to a critical point and our ambition to speed up clinical trials is ready to become a reality. “Right now our amazing MS researchers are finalising which treatments Octopus will test first and later this year we hope to start recruiting people with progressive MS to take part.” Octopus is just one of many vital research projects made possible by the MS Society’s Stop MS Appeal, which aims to raise £100 million to find treatments for everyone with MS.

www.mssociety.org.uk

“Octopus is a game changer for how MS clinical trials are run. As well as testing many treatments at the same time with only one placebo arm, we’ll use an interim analysis of MRI scans to allow us to progress to the next stage much quicker.”

Prof. Olga Ciccarelli

About multiple sclerosis

Over 130,000 people live with MS in the UK MS damages nerves, making it harder to do everyday things such as walking, talking, eating and thinking It is relentless, painful and disabling It can be unpredictable and different from person to person Approximately 85% of people with MS are diagnosed with the relapsing form, where symptoms come in sudden attacks, then fade Two in three of them will go on to develop secondary progressive MS, where there is no remission and they become increasingly disabled

10-15% of people have primary progressive MS, where symptoms gradually get worse from the outset.

The MS Society has a free helpline on 0808 800 8000 and a website at www.mssociety.org.uk