Queen’s University Belfast: World-First MS Mega-Trial Opens Site in Northern Ireland, Offering New Treatment Hope

Participants are already being recruited to the MS Society-funded Octopus trial, with 123 volunteers from NI expected to take part over the next five years.

Octopus is lead by the Belfast Health and Social Care Trust alongside researchers from Queen’s University Belfast.

Octopus is a multi-arm, multi-stage (MAMS) trial, designed to transform the way treatments for progressive MS are tested. Its focus is on existing drugs already approved for the treatment of other conditions, but which may also work to slow down or reverse MS progression. Multiple drugs are tested at once, rather than testing one drug at a time against a placebo. This method works up to three times faster than traditional trials.

Ian Young, 61, a Civil Servant from Armagh City, was one of the first participants recruited to the Octopus trial’s Belfast site.

The father of three, who was diagnosed with secondary progressive MS in the late 1990s, said: “For the whole time I’ve had this condition – which is a long time – there’s been nothing I’ve been able to do about it. There was a certain amount of frustration involved in that.

“My hope at the minute is that the Octopus trial will lead to researchers finding a treatment that will slow down MS progression, and I will be able to maintain the quality of life that I have now. If they were to come up with something that reversed the symptoms, and the progression, then that would be fantastic. But I’m trying not to get ahead of myself. I’m just hoping that, as a first step, they can put the brakes on a bit.”

Ian’s symptoms include fatigue, numbness, spasticity (muscle stiffness and spasms), balance issues and restricted mobility. His MS is also made worse by both heat and cold. He’s not currently eligible to take any MS treatments but has been prescribed vitamin D.

He added: “The people involved in the trial are all very good, really helpful and considerate. I feel very well looked after. It’s really great that progressive MS is now getting so much attention. It definitely gives me hope.”

MS is a condition that affects the brain and spinal cord. This impacts how people move, think and feel.  More than 130,000 people live with MS in the UK; consultant neurologists say latest figures show more than 5,500 of those are in Northern Ireland. For the tens of thousands who have one of the progressive forms, they have little to stop their MS getting worse.

Stewart Finn, Northern Ireland Director at the MS Society, said: “People living with primary or secondary progressive MS currently have very few treatment options available to them. Octopus has the potential to change that by developing life-changing treatments far sooner than a traditional trial would be able to.

“This trial represents a major step forward for MS research globally, and we’re really pleased that both medical professionals and members of the MS community in Northern Ireland will be a part of that.”

A MAMS trial changed the way men with prostate cancer are treated around the world. But this type of research has never been used in relation to MS treatments, until now.

In Northern Ireland the trial will be led by Consultant Neurologist Dr Gavin McDonnell as part of a multidisciplinary team from the Belfast Health and Social Care Trust. The site is based in the NI Clinical Research Facility at Belfast City Hospital.

Dr McDonnell, who is also Honorary Senior Lecturer at Queen’s University Belfast, said: “We’re delighted to be working in partnership with the MS Society and Queen’s University to drive forward MS research in Northern Ireland. The unique design of Octopus will allow us to identify and fast-track treatments of particular promise.

“We want to emphasise that while the trial is based in Belfast, we’re keen to ensure access is open right across Northern Ireland. The 20 patients formally screened so far are drawn from all five of the Health and Social Care Trusts (HSCTs) here. Unlike many previous MS treatment trials, Octopus is open to a broad range of patients, including those with more advanced mobility issues. We are aiming to recruit 38 patients here by the end of December 2024 (for phase 1) and then a further 85 patients in the following three years for phase 2 of the trial.”

Professor Denise Fitzgerald from Queen’s University is a leader in the field of MS research and will be part of the multi-disciplinary team for the Octopus trial in NI. She said: “We’re delighted to see the Octopus trial site opening in Belfast. Having a site in Northern Ireland will give people here equitable access to this revolutionary trial.

“The research study embedded within this trial will allow researchers, like us, to learn more about disease progression in MS and how treatments may work to slow down that progression. This will also support cutting-edge training of the next generation of clinicians and scientists specialising in MS, right here in Northern Ireland.”

Octopus is open to people aged 25 to 70 at the time of enrolment. Everyone from those who can walk short distances without aid to wheelchair-users who still have use of their arms, can be eligible to join the trial, as long as their MS has progressed in the previous two years. Participants can continue to take their prescribed MS treatments while on the trial.

The first Octopus site opened in London in spring 2023 and there will eventually be up to 30 sites throughout the UK. The trial has also been extended to Australia, where it’s called Platypus; 250 participants are expected to be recruited there.

Octopus will test several experimental MS therapies against a shared control group. This is what makes the trial multi-arm.

Treatments that appear effective from early data can continue into the next stage without the need to set up a new trial and new infrastructures. The assessments in phase 1 of the trial will be done using MRI scans and clinical evaluations.

If a drug shows promise in this first stage, it will move into the trial’s second stage, where disability progression will be assessed. Drugs that don’t show promise will be removed from the trial and new treatments will be added. This is what makes it multi-stage.

The trial is currently testing two drugs, metformin, which is approved for diabetes in the UK, and alpha lipoic acid, which is approved for neuropathy – a type of nerve damage – in Germany. Both drugs have shown potential to help protect nerves.

Dr Rachael Kee, Consultant Neurologist and Honorary Lecturer at Queen’s University Belfast, said: “We’re delighted to see the Octopus trial site opening in Belfast. This is a major moment for MS research and having a site in Northern Ireland will give people here equitable access to this revolutionary trial. Whilst treatments for relapsing-remitting MS have been advancing at pace, treatments for progression in MS are lacking. This is a key, unmet need.

“The Octopus clinical trial is seeking to find effective treatments for slowing progression in MS. This trial will be able to research multiple potential treatments in parallel, and thus speed up the time it takes to find out if a treatment is effective and subsequently becoming available for people with progressive MS sooner.”

Octopus is being funded by donations to the MS Society’s Stop MS Appeal. Stop MS needs to raise another £30 million of its £100 million target to help find treatments that could slow or stop the build-up of disability for everyone with MS. University College London (UCL), where the first Octopus site is based, is the trial sponsor.