We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Jeremy
Chataway
+44 (0)203 108 1955
j.chataway@ucl.ac.uk
Dr
Cheryl
Pugh
+44 (0)207 670 4700
mrcctu.octopus@ucl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Primary progressive multiple sclerosis and secondary progressive multiple sclerosis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 16/10/2024:
Core Inclusion Criteria:
1. Participants with a confirmed diagnosis of MS
2. A diagnosis of Secondary Progressive MS (SPMS) or Primary Progressive MS (PPMS)
3. Steady progression as assessed by the treating clinician, rather than relapse, must be the major cause of increasing disability in the preceding 2 years. Progression can be evident from either an increase of at least 1 point if on the Expanded Disability Status Scale (EDSS) score <5.5, or an increase of at least 0.5 point if EDSS score ≥5.5, and/or clinical documentation of increasing disability
4. EDSS 4.0 – 8.0 (inclusive) as assessed at the time of randomisation by the assessing clinician
5. Aged 25 - 70 years old inclusive on the day of randomisation
6. Adequate renal function at screening, defined as eGFR ≥60ml/min/1.73m² (as per local method)
7. Normal liver function at screening consisting of all the following:
7.1. Serum bilirubin <1.5 x ULN (except for participants with Gilbert’s disease, for whom the upper limit of serum bilirubin is 51.3 μmol/l or 3mg/dl)
7.2. Either aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <3 x ULN; (it must be stated whether one or both tests were performed. Where both results are available, both must confirm eligibility)
7.3. Alkaline phosphastase <3 x ULN
8. Must be able and willing to comply with the treatment and assessment schedule and requirements including being able to start trial treatment ≤ 2 weeks after randomisation.
9. Written informed consent provided
10. Must have a QC-approved (as defined in MRI guide) MRI ≤ 4 weeks before randomisation (Stage 1 of study ONLY)
11. Willing and able to have MRI scans in accordance with the assessment schedule and no contraindication to MRI (Stage 1 of study ONLY) please refer to MRI Procedures and Protocol for further detail.
Redacted drug B Inclusion Criteria:
Participants will be considered eligible for randomisation in this trial if they fulfil all the core inclusion criteria and none of the exclusion criteria as defined in sections 3.1 and 3.2 in the main protocol in addition to the arm specific criteria below. If a participant is ineligible for this arm, they can be assessed for eligibility and randomised to other open arms.
Redacted drug A Inclusion Criteria:
Participants will be considered eligible for randomisation in this trial if they fulfil all the core inclusion criteria and none of the exclusion criteria as defined in sections 3.1 and 3.2 in the main protocol in addition to the arm specific criteria below. If a participant is ineligible for this arm, they can be as
You may not be able to take part if:
1. Relapse ≤ 12 weeks before randomisation2. Significant comorbidity (as confirmed by treating clinician)2.1. Cardiac failure (clinical diagnosis)2.2. Significant Respiratory comorbidity2.3. Renal failure2.4. Malignancy (except if in complete remission) – e.g. solid organ or haematological or melanoma2.5. Uncontrolled thyroid disease3. Rare hereditary problems of galactose intolerance or glucose-galactose malabsorption4. Active partial or total malabsorptive disease (e.g. coeliac disease)5. Has a history of alcohol use disorder and/or drug abuse (excluding cannabis for symptomatic relief)6. Female participants that are pregnant or breast-feeding.7. Women of child-bearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception whilst on trial treatment and up to 12 weeks after the last dose of study drug.8. Participation in another clinical trial of an investigational medicinal product or medical device ≤ 26 weeks before randomisation9. Men with a partner of child-bearing potential unwilling to use an acceptable method of contraception during the trial and for 12 weeks after the last dose of trial treatment.10. Male participants unwilling to desist from sperm donation during the trial and for 12 weeks after the last dose of trial treatment.11. Been treated with steroids (intravenous and/or oral) for MS relapse or progression ≤ 12 weeks before randomisation*Note: Participants on steroids for another medical condition may be included in the trial provided the steroid prescription is not for any aspects of their MS.12. Current or previous treatment with Analysis Stage 1 IMPs ≤ 26 weeks before randomisation. With the exception of participants taking [redacted drug name and dosage]. These participants can be randomised but must wait 7 days from the last dose before randomisation.13. Commencement of DMT and/or fampridine ≤ 26 weeks before randomisation*14. Contraindicated medications that are not permitted with Analysis Stage 1 IMPs. Please note a careful approach should be applied to those listed with caution. Please contact the OCTOPUS team if further advice is required.15. Participants who are not eligible for any of the trial IMPs, according to the eligibility criteria listed in the individual drug appendices. Please note that participants can enter the trial if they are eligible for at least one of the trial treatment arms, but do not need to be eligible for all.*These participants may undergo a further screening visit once the specified window has expired and may be included if no further treatment has been administered in the intervening period.
Redacted drug B Exclusion Criteria:Arm-specific exclusion criteria to be added when drug names released
Redacted drug A Exclusion Criteria:Arm-specific exclusion criteria to be added when drug names released
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Cheryl
Pugh
+44 (0)207 670 4700
mrcctu.octopus@ucl.ac.uk
Prof
Jeremy
Chataway
+44 (0)203 108 1955
j.chataway@ucl.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University College London; Griffith University and funded by Multiple Sclerosis Society.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 54274
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
