Clinical Trials Network for Progressive MS. Part 1

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You have been complaining that there is no interest in developing treatment for progressive MSer. However, you are wrong there has been lots of activity going on but it has not really surfaced.
 
Last week we were mentioning the International Progressive MS Collaborative which aims to expedite the development of effective disease modifying and symptom management therapies for progressive forms of MS.

But perhaps we should also introduce the Clinical Trials Network (CTN), which was set up specifically for Progressive MSers. This has been reported in some places but may not be common knowledge. As you know all too well, there are currently no disease modifying treatments (DMTs) available for
progressive MS hence this is a significant unmet need. The MS Society
is dedicated to supporting research in this important area and has been
committed to this from many years. They set up the CTN and have been committed to this since the beginning.

This was partially born following the involvement of UK Scientists and the MS Society of Great Britain and Northern Ireland with the Promise 2010 initative from the National (USA) Multiple Sclerosis Society. To their credit, it was evident that UK Clinicians could collaborate and get things off the ground with the initiation of some of the first major trials on progressive MS.

In late 2007 the MS Society established the UK MS Clinical Trials Network (CTN) and tasked the Network with planning and conducting large scale clinical trials for progressive MS. The CTN currently comprises a large number of UK-based clinicians,
scientists, statisticians and people affected by MS and is led by the MS
Society of Great Britain and Northern Ireland.

They comissioned some enabling studies to investigate outcomes, trial design, drug selection, patient outcome measures and drug screening of novel candidates

The MS Society then established the CTN steering group which was tasked with expediting the planning phase of the initiative. The Society appointed as independent Chair of the steering group who has extensive experience in planning and running large scale clinical trials. The steering group comprises a subset of members of the wider CTN and people affected by MS

In 2010 the Society identified several university-based Clinical Trials Units (CTU), which are expert in all areas of clinical trial design and execution and can assist with the logistical challenges of planning and running a clinical trial.CTUs in the UK that appeared to have the relevant skills and experience to assist with this particular trial and put out a call for expressions of interest. Two CTUs expressed an interest in partnering with the Society on this initiative. The steering group commended that the Society partner with one of them. Subsequently a Scottish-based CTU accepted an invitation to join as a partner to this initiative.

A Chief Investigator (CI) for the trial was appointed to lead on this particular trial through the CTN.

In recognition of the rigorous peer review and monitoring processes the MS Society received National Institute for Health Research (NIHR) portfolio status for the entire research portfolio, including activities of the CTN. This will ultimately reduce the cost of clinical trials by providing access to Department of Health funded resources such as neurologists, trial nurses and statisticians.

Drugs were selected for the trial and novel trial design based on suggestions from the HTA. This was an adaptive design aimed at running a number of agents side by side, the good ones continue and the bad ones failing are replaced.


In 2011 an application to the Health Technology Assessment programme (HTA) from the UK Government was made for funding to support the trial.

The trial was not supported due to cost and the HTA changed its mind about the trial designs it wanted to fund, so 4 years of planning down the pan. This shows that it is never plain sailing on any such study.

You dust yourself down, reflect and carry on and try again However, we are in good shape for the International Collaborative. More on the CTN soon.


Despite the disappointment  but you may be interested to know that there is another Clinical trials network in Australia where you can sign up to be part of a clinical trial (All types of MS)

About the author

MouseDoctor

15 comments

  • While one is glad trials for progressive MS are being arranged, the truth is that progression is the most malevolent aspect of multiple sclerosis, and it affects everyone with the disease. Some are badly affected within a relatively short period of time, for others it’s protracted but continuous. Progression is the insidious evil and it’s kicking all our asses.

    I read about that 13 year old kid with PPMS you’re treating. My heart sank. While I’m happy the neurologists at Barts made an effort with aggressive immunological treatments, the result is the child got still got very disabled. Did it slow down her progression? It doesn’t look like it.

    This post is merely an account of the designing and planning groundwork being done, there’s still a long while to wait to see if any of it pays off, and even then it doesn’t look like the drugs being trialled will be a giant leap forward.

    You most certainly have plans. I do not doubt that. The problem is that despite all the reporting you’ve done I’m none the wiser of what you hope these drugs will achieve. Will you be able to restore? Will you cease progression forever? Will it just be a marginal slowing down of progression?

    The CUPID trials were an embarrassing failure despite all the goodwill. Eight years, millions of pounds and nothing to show for it. I hope the CTN is not all hot air as is usually the case.

  • "You have been complaining that there is no interest in developing treatment for progressive MSer"

    My complaint isn't about the level of interest, but the fact that there are no current treatments / and no treatments on the horizon. Not an unreasonable complaint given that research has been going on for 50 years.

    When I was diagnosed 10 years ago, the national MS websites all talked abou big breakthroughs and repair. 10 years later – zilch.

    As poster above says – CUPID trial was a disaster. What smart alec came up with the theory that it might work? Anothe example is the lamotrigine trial – I followed this closely as the MS society said it could be the first treatment for progressive MS – it failed! While the baove looks interesting – it's all about organisational structures – I don't see any names of treatments. What happened to all the stem cell hope e.g. Prog Scolding?

    On the positive side, I like you Mouse Dr (apart from your crap taste in music). I think you see through some of the farce that surrounds MS research and the influence of big pharma.

  • This is an interesting blogpost about "Why haven’t we cured cancer yet, anyway?"
    http://scienceblogs.com/insolence/2011/02/21/why-cant-we-cure-cancer/

    Answer starts with:
    "… it’s a bit of a misleading question, given that we can actually cure quite a few cancers, …"
    Main answer:
    "Because it’s hard. It’s very, very hard. It’s harder than going to the moon; it’s harder than building the nuclear bomb; it’s harder than wiping out smallpox. All of those were, of course, also very, very hard too, but cancer is a harder nut to crack still. It’s hundreds, perhaps thousands, of diseases. Each type of cancer can be many, even dozens, of different diseases in itself. …"

    MS is a single disease, but maybe it is as hard as one of these currently incurable cancers.

    Re "What smart alec came up with the theory that it might work?" – You can never be sure a treatment will work, otherwise why do the trial at all? It's very disappointing, but there's always a chance a trial will be unsuccessful

  • "While the looks interesting – I don't see any names of treatments".

    When every thing is in place and the study is finalised and announced, then names of treatments will be anounced. Until that time it is watch this space.

    "What happened to all the stem cell hope e.g. Prof Scolding?"

    Its still ongoing I believe, as are other studies, but they are in their infancy. I think that there are massive hurdles to overcome with this approach.

    I personally think getting what is there to cause repair is the best chance of success rather than transplating cells in. But I am happy to be proved wrong.

  • Will you be able to restore? Will you cease progression forever? Will it just be a marginal slowing down of progression?

    These are different treatment paradigmsn restore is turning back the clock…this is the hardest task at the moment, this is were the stem cell approach is aimed.

    Ceasing progression may also be stem cells but it may be a different approach also. However if we control disease early and aggressively this may be a reality
    That is achieved now.

    Slowing down progression is the most realistic in the CTN approach.

  • My complaint isn't about the level of interest, but the fact that there are no current treatments / and no treatments on the horizon".

    There are no current treatments…yet available I agree but you may be wrong about no treatments on the horizon.

    Whilst I have my doubts about drugs like Gilenya being useful for all aspects of progressive MS, I bet there will some progressive MSers who get benefit from this treatment. This trial is ongoing now.

    BG12 is also a new drug that is being assessed by the regulators for RRMS at the moment.This should be available soon.

    Based on the mechanism of action of BG12 there is every reason to suspect that this will control disease processes that we think are important in progression. I am hopeful.

    As to drugs to be examined by CTN they are already used in humans in other disease conditions.

    It would be defeatist to think that nothing changes but within the last ten years there are now drugs that really impact on the disease process.

    Maybe if you treat aggressively at diagnosis then maybe that is that..this could be done now so ten years on there has been progress, but not quick enough

  • I have my fingers crossed for Team G's LP project because that would speed up the next decade enormously. If one somehow would achieve to make the trials quicker and at least 1 effective drug which slows progression considerably plus more symptom relief drugs and I would be contended (well, sort of).

  • I have my fingers crossed for Team G's LP project because that would speed up the next decade enormously

    Me too, legs crossed also and thats not because I'm desparate for the loo:-)

  • Seen the results of trial
    No effect overall

    but they said

    "There was signficant treatment benefits in people with lower disability score (EDSS less than 6) with strong evidence that treatmment effects (slows) time to progression p=0.00014".

    So about 1 in 5,000 likelihod of getting this result due to chance . This was based on results from about 100-120 MSers.

    The must have been a placebo effect also as there was less progression than expected

  • I posted about being interested in participating in a ppms trial and whether I would be eligible as I have turned 50. It seems to have been removed ? why. I have tried to send an email to the email address given under trials to no effect.Any ideas. I don't see my Neurologist for several months and fear it will be too late.

  • Re: "I posted about being interested in participating in a ppms trial and whether I would be eligible as I have turned 50. It seems to have been removed ? why?"

    You shouldn't have; to be in the trial you need to be referred to the Royal London Hospital for an assessment. Regarding contacts for the trial you can try:

    1. Dr Klaus Schmierer; k.schmierer@qmul.ac.uk
    2. Ms Guarnieri Ceri; Ceri.Guarnieri@bartshealth.nhs.uk
    3.Ms Jennifer Ross; Jennifer.Ross@bartshealth.nhs.uk

    Good news is the cut-off age has been extended to 55.

  • It was deleted Why.

    Prof G has answered this but it was not deleted. Comments are sometimes moved to unrelated blogger post on right.

    In the post above they have to be cleared for next months post but they are copied and pasted.

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