Groundbreaking 'mega trial’ for people with multiple sclerosis launched in Southampton

University Hospital Southampton (UHS) has opened a groundbreaking ‘’mega trial” for people living with progressive forms of the debilitating neurological condition, multiple sclerosis (MS).

MS is a condition which occurs when the immune system attacks the protective lining of the nerve fibres in the brain and spinal cord, causing damage and scarring.

This can lead to a range of symptoms including movement, vision and balance problems, numbness and tingling and muscle stiffness and spasms which gradually worsen and, currently, there is no cure.

Known as Octopus – which stands for Optimal Clinical Trials Platform for Multiple Sclerosis – the trial will see several drugs tested simultaneously.

UHS has been selected as one of four national regional hubs to help boost support and recruit trial participants. The Trust will recruit around 125 people with progressive forms of the condition and is one of 30 sites expected to open across the UK.

The design of the trial means it works up to three times faster than traditional trials because of the ability to test multiple drugs at the same time, dropping those which aren’t successful and adding in new ones based on emerging results.

Funded by the charity the MS Society, Octopus has been hailed as a “major moment for MS research”.

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.

There are three main types of MS – relapsing (a form of the condition where symptoms get worse then recover), primary progressive (gradual worsening of symptoms from the start) and secondary progressive (follows initial course of relapsing but moves to progressive).

More than 130,000 people live with MS in the UK and tens of thousands have progressive forms of the condition. There are few treatment options available to stop the condition from worsening.

Frank Bailey, 57, lives with his wife near Chichester and runs his own landscaping business. Eight years ago, he was diagnosed with progressive MS.

He said: “It was a relief. I can actually say I did cry when the neurologist told me. I didn’t cry because I had MS, but because I finally had an answer to what was wrong with me.

“I’d gone through ten years of people telling me it was my back. The last stop was a neurologist, and she told me I had MS. Having that diagnosis meant I could deal with it.”

The condition meant Mr Bailey, who could previously lay 40 square metres of paving a day, can now only manage half that.

He added: “I stumble, and my balance is rubbish. It’s affected my eyesight – I never used to wear glasses, but now I do, just to see the fine detail.

“It’s frustrating and has massively affected my way of life. I have to find other ways of doing things, but for now I’m still doing the job I love doing and hope to continue doing that for as long as I can.”

Currently there are no further treatments to prevent his type of MS from getting worse, but one way for Mr Bailey to take back control was to join the Octopus trial.

He said: “I’ll be overjoyed if the treatment I receive works and stops my condition from getting worse, but my main reason for joining the trial was to help future generations.

“MS needs to be driven forward and put in the limelight more – especially my type, progressive MS.”.

The drugs being tested in the first two ‘arms’ of the Octopus trial are metformin and a version of alpha-lipoic acid.

Metformin is a drug commonly used to treat a type of diabetes while alpha-lipoic acid is a food supplement that acts as an antioxidant, but both have shown promise in treating the nerve condition neuropathy.

Octopus will test whether these drugs are able to protect nerves from damage in MS and establish the right formula and dose that is safe, with more drugs set to be added to the trial in the future.

The trial in Southampton is being led by Professor Ian Galea, neurological consultant at UHS and Professor of clinical and experimental neurology at the University of Southampton.

He said: “Octopus is a landmark trial that is designed to maximise the probability of finding a treatment for progressive forms of MS in the shortest possible time.

“Southampton has a long-standing expertise in progressive MS studies and because progression of the disease is likely to have many influencing factors, we take a number of different approaches.”

A recent study examined the link between infections and spinal cord shrinkage. Southampton is also participating in a trial testing a cholesterol-lowering drug in secondary progressive MS.

Scientific studies are also examining the role of two potential drivers of progression - haemoglobin, the red pigment in blood, and the blood-brain barrier which serves to protect the brain during infections.

Prof Galea added: “Octopus will therefore be another important study in a local portfolio of research that is dedicated to stopping progression in MS.”

Dr Emma Gray, assistant director of research at the MS Society, said: “This is a major moment for MS research – Octopus has the potential to change the clinical trials landscape around the world. It's thanks to all the wonderful participants that trials like this can happen.”

The Octopus trial in Southampton is open to people with progressive MS. To find out more or to register your interest visit the MS Society website.