World first trial for patients with progressive MS launches in the UK

Dr Sean Apap with Aisla Guidi
Dr Sean Apap with Aisla Guidi

The first patients have been recruited for a revolutionary trial, led by UCL researchers, that will transform the way that treatments are tested for progressive multiple sclerosis (MS).

Octopus is a world-first clinical trial, funded by the MS Society and led by researchers at the MRC Clinical Trials Unit at UCL. The trial is multi-arm and multi-stage (MAMS) and should work up to three times faster than traditional methods.

By testing multiple drugs at once, and using MRI scanners to get an idea of whether a drug has potential, the trial adds to the flexibility to drop drugs that don’t look promising, cutting the overall testing time needed.

More than 130,000 people live with MS in the UK, and tens of thousands who have the progressive forms have nothing to stop their MS getting worse.

Most people with MS experience two stages of the disease: Early MS - Relapsing-Remitting MS (RRMS), which is partially reversible, and Late MS - Secondary Progressive MS (SPMS), which affects the majority of patients, usually 10 to 15 years after diagnosis.

Disability progression is caused by degeneration of nerves in the brain - something that happens to everyone during the ageing process but more quickly in MS and other neurodegenerative conditions, like Alzheimer’s and Parkinson’s. However, there are currently no treatments that target this.

After working with experts and patients to review and rank potential treatments over the course of several years, the researchers decided to focus on existing drugs used in other conditions that have the potential to protect nerves.

Consequently, the trial team selected R/S alpha lipoic acid (used to treat conditions such as diabetic neuropathy) and metformin (used to treat type 2 diabetes), as the first two drugs to test in the ’arms’ of Octopus.

Participants are now being screened at the first clinical trial site, UCLH in London. Other locations with confirmed sites, but that are yet to open, include Belfast, Edinburgh, Cardiff, Coventry, Leeds and Southampton. There will eventually be up to 30 sites around the UK, including Scotland, Wales, Northern Ireland, Yorkshire, the West Midlands and the South of England.

Professor Jeremy Chataway (UCL Queen Square Institute of Neurology), who is leading the trial, said: "The multi-arm, multi-stage approach to trialling emerging medications has been utterly transformative in other conditions, so I’m thrilled we’re now able to apply it to MS. Ultimately, Octopus will lead to more treatments for progression becoming available to people living with MS sooner.

"Getting to this stage has been an incredible effort of people up and down the country. The other large trial I am the Chief Investigator for, MS-STAT2, has shown we can run large-scale, nationwide trials for progressive MS. Now we’re taking it to the next level, as we start a new journey to develop treatments for progressive MS. I know our amazing community of people is poised to help us make it to the top, so we can find the answers we so desperately need."

The same MAMS approach used in Octopus was also used to change how men with prostate cancer are treated, thanks to the STAMPEDE trial which answered eight research questions about treatments in 15 years, rather than more than 50 years as it would have taken using a traditional design.

Professor Max Parmar, Director of the MRC Clinical Trials Unit at UCL, who led the development of STAMPEDE, said: "When the MS Society asked me to help create one of the first ever multi-arm multi-stage trials for a neurological condition, I was up for the challenge. Octopus will use the innovative aspects of STAMPEDE plus some even more advanced features.

"The key thing about STAMPEDE is that we’re getting answers to our questions decades faster than we would with any other approach. To find treatments for everyone with MS, we need trials to be as inclusive as possible and produce results much faster. This is what we want Octopus to achieve."

Octopus is being funded by donations to the MS Society’s Stop MS Appeal.

Dr Emma Gray, Assistant Director of Research at the MS Society, said: "Launching the world’s first multi-arm multi-stage trial for MS has long been an ambition of ours and opening the doors to Octopus is a momentous milestone. 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. By tapping into the potential of approved drugs, which may have the potential to protect nerves, we can develop new treatments for MS faster."

Patient story

Ailsa Guidi, who is 47 and from Surrey, is one of the first participants on the Octopus trial. She was diagnosed with relapsing MS in 1999 when she was 24. She was told at the start of last year her MS had progressed to secondary progressive MS. Her mobility has been affected and she lives with daily fatigue.

Ailsa - who has three children and is medically retired - says: "When I was diagnosed with MS the doctors were keen to start me on a disease modifying therapy (DMT) straight away. But in 2015 I had a relapse which I didn’t get better from. Ever since my mobility has been permanently affected. It’s better or worse depending on the day, but I always use a walking aid, a two-wheel walker or a wheelchair. I also have an electric trike I use to go for a walk.

"In February 2022 my neurologist told me my MS had progressed to secondary progressive MS - something I knew was coming as my MS had got worse but didn’t really want to hear. There are two treatments available that can help some people with secondary progressive MS but I’m sadly not eligible for them. I’m a positive person but facing progressive MS feels quite different from living with the relapsing form.

"It’s a strange thing to say, but a family friend said to me ’it’s a good time to have MS as there’s so much happening in research’ and they’re right! My husband read about the Octopus trial in an MS Society newsletter last year. I said I had enough to focus on just managing my MS to sign up and asked him to instead! Since then, and after being accepted last month, I feel excited that I’m joining a long line of people who have helped progress MS research. Octopus has the potential to find treatments for people, like me, living with progressive MS - it’s given me hope."

Anyone who has primary or secondary progressive MS in the UK can register their interest via the UK MS Register. Visit: www.ukmsregister.org/octopus

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