• Principal Investigator/s: Dr Gavin McDonnell

• Name of the Study: OCTOPUS (Optimal Clinical Trials Platform for Progressive Multiple Sclerosis).

• Why is this Study important?

MS is the commonest progressive neurological disease of young adults, affecting over 130,000 patients across the UK. Treatments for MS have advanced considerably over the past 20 years but effective options for patients with progressive and more advanced disease remain limited. This revolutionary trial is being conducted UK-wide and uses a multi-arm multi-stage (MAMS) adaptive platform design to evaluate a number of potential treatments for such patients.

• What is the Research question/aim?

To speed up the assessment and development of novel and repurposed treatments that slow or stop the accumulation of disability progression in MS, through the broad mechanisms of neuroprotection and remyelination.

• What the Study involves:

The initial stage of the trial tests two repurposed drugs (Alpha Lipoic Acid and Metformin) that target key mechanistic pathways in progressive MS. There will be a comparator placebo group with 1/3 of patients randomised equally to the two drug groups and placebo. Patients entering phase 1 of the trial will attend the NICRF for regular assessments and will undergo regular MR imaging of the brain and spinal cord.

An interim analysis, based on MRI brain atrophy, will occur once patients in each of the arms have had at least 18 months follow-up (3 years after recruitment commences). Those treatments meeting pre-specified criteria suggestive of efficacy will continue to phase 2 of the trial and may be joined by other potential treatments.

It is anticipated that 38 patients in NI will be recruited to phase 1 and 85 to phase 2.

• Who can take part in the Study?

Among the key criteria are that patients must have a definite diagnosis of MS and be following either a primary or secondary progressive course, aged 25-70yo. There should have been a progression in disability over the previous 2 years and in terms of the disability rating scale used in MS, the EDSS, patients should be between 4.0-8.0.

• Contact Information: Patients considering participation in the trial can register their interest at org/octopus or by contacting the NICRF OCTOPUS team at OctopusTrial@belfasttrust.hscni.net

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