A multicentre, interventional, multi-arm, multi-stage trial including randomisation, double blinding, placebo control evaluation of treatments for slowing the progression of disability in participants with Secondary Progressive Multiple Sclerosis (SPMS) and Primary Progressive Multiple Sclerosis (PPMS), together termed Progressive Multiple Sclerosis (PMS) (OCTOPUS)

Research summary

Multiple sclerosis (MS) affects more than 130,000 people in the UK and over 2.5 million people worldwide. MS often begins with a relapsing-remitting phase (RRMS). However,over time,many people with RRMS start to find that they no longer recover after a flare-up (also known as a relapse) and get steadily worse,resulting in increased disability. This is known as secondary progressive MS (SPMS). A smaller number of people experience a gradual decline from the beginning,known as primary progressive MS (PPMS). SPMS and PPMS together are known as progressive MS. Recently,the first treatments have become available through the NHS for people with progressive MS. However,these treatments are only available to those who have had a relapse or have shown activity on an MRI scan. There are few clinical trials testing for effective treatments in progressive MS even though it is a major unmet need. The main aim of OCTOPUS is to find treatments that can slow down,and ultimately stop,the progression of disability in people with progressive MS. This will be done by testing “repurposed” treatments (i.e. treatments already in use for other conditions),over several years,using the multi-arm multi-stage (MAMS) trial design. This method has many advantages over traditional trials. Firstly,it allows several treatments to be tested at the same time against a common control (i.e. “multi-arm”). Secondly,it allows data to be analysed while the trial is ongoing,rather than only at the end. This means that decisions can be made on early results about stopping treatments that do not show promise. Thirdly,when new information about different treatments becomes available,these treatments can be added into the trial. Finally,treatments which appear to be effective from the early data can continue onto the next trial phase without the team having to stop and set up a new trial (i.e. “multi-stage”). Using repurposed treatments means there is already an understanding of their safety and possible side effects and it will take less time to test them for progressive MS. By using this approach and adding new treatment arms when promising treatments are found,we can find effective new treatments for progressive MS quicker.

Principal Investigator

Dr Ruth Fernandes Geraldes

Contact us

Email: dendron@ouh.nhs.uk

IRAS number

1003943