In two years of blogging about anything and everything to do with living with CRPS, this is probably the most exciting article I’ve ever written. Truly. This is news that could potentially be life-changing for CRPS sufferers everywhere.
Some history first: almost exactly two years ago, I wrote about a new CRPS treatment available in Italy that those doctors described as the cure for CRPS. That article was hopeful, with a few caveats: there was little data out there beyond the anecdotal to suggest that this drug really was as effective as claimed, and crucially, the treatment was only available in Italy and only accessible to those who could afford thousands of Euros to pay for it.
Well, that’s not the case any more. Neridronate infusions are now available, for free, in the UK as part of a large-scale clinical trial. Read on to find out how you can get this treatment.
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The major pharmaceutical company, Grünenthal, has now started its Phase III trial of neridronate for CRPS that was announced earlier this year. Neridronate was given a Breakthrough Therapy Designation for CRPS back in 2017 by the American Food and Drug Administration; this means that neridronate is viewed as a potentially revolutionary treatment for this formerly largely untreatable condition and therefore it’s been put on the fast track for approval.
What does the initial stage of the trial involve for participants?
Everyone who signs up to the trial will initially be randomly allocated to a group where they either receive a placebo or the real medicine. No-one will know which group they’re in; not the patients nor the doctors. This is so the researchers can ensure that reactions to the medicine are genuine and not influenced by expectation.
Participants will then receive 4 infusions over 10 days of either placebo or neridronate, where the medicine is administered through a drip into a vein. These infusions will happen in a hospital or clinic with constant monitoring from medical personnel. You’ll be asked to keep a detailed diary of how you feel for six months afterwards, covering pain levels and any other effects you may experience. You’ll be asked to take supplements of Vitamin D and calcium too, as a precaution because neridronate has an effect on bones, and you’ll be given paracetamol to take after the first infusions as occasionally they can cause flu-like symptoms, but these should pass fairly quickly.
What’s the next phase?
After six months, you’ll be reassessed and then may have the option to have further infusions. This will likely happen if you’ve been given the dummy medicine in phase 1, or if the doctors think you might benefit from further neridronate infusions. What this means is that everyone will have the chance to experience the real medicine, regardless of whether you receive placebo in the first phase.
If you do go into this next phase, you’ll again receive 4 infusions over 10 days, but these will definitely be of the real medicine. You’ll once again need to keep a diary for the next six months to monitor the effects. The experience of patients who’ve had the treatment in Italy suggests that it may take as long as six months to start feeling the benefits of the medicine, hence the long follow-up period. Don’t expect that you’ll necessarily feel better overnight and don’t assume the treatment has failed if you don’t quickly see a change in your pain levels. Overall, participation in the trial is likely to take about 14 months so you need to be sure you can make that commitment.
This is the only piece of ‘bad’ news I have to impart: the trial is only open to those who’ve had CRPS for less than two years. That means, regardless of when you received a diagnosis, this trial is only open to those who’ve had symptoms of CRPS for less than two years. Although this is disappointing to anyone who’s suffered with the disease for longer (like me), the rationale behind it is understandable; as many sufferers would attest, the longer you have the condition, the more problems it tends to cause, ranging from issues with the central nervous system to thyroid deficiency to problems with the eyes, bladder, bowel, heart and other organs. This trial needs to understand if this treatment works for pure, simple CRPS, unencumbered by other medical problems that tend to arise after you’ve had CRPS for a while, and thus they’re limiting participation to those who haven’t had it too long. Like I said, disappointing but understandable.
Even if you don’t have a CRPS diagnosis…
Trial participants can have CRPS type 1 or 2 and they don’t even need to have a confirmed diagnosis as yet; the trial locations can also diagnose, so if you think you’ve developed CRPS within the last two years, regardless of whether a doctor’s told you that’s correct, it’s well worth getting in touch.
Are there are contraindications?
Women cannot get pregnant whilst using neridronate as it’s known to cause birth defects, so if you’re planning a pregnancy anytime soon that could rule you out. You have to have an average daily pain score of more than 4 (not generally a problem for anyone with CRPS, sadly!) and you must be taking no more than a morphine equivalent dose of 200mg daily if you’re on an opioid painkiller. Your medications must be stable and you’re asked to keep them that way during the trial. Throughout the study you’ll have regular blood tests done and the infusion will be given through a drip into your vein, so if you’re scared of needles that might be problematic.
How do I find out more?
The UK trial is being headed up by a team from St Pancras Clinical Research in London. If you visit the linked page, you can fill in a short form and they’ll contact you to discuss the trial further.
Where is it taking place?
The trial is happening in 8 locations across the country: Liverpool, Manchester, Barnsley, Cannock, Blackpool, Leeds, Stockton-on-Tees and London. If you participate, then they’ll reimburse all reasonable travel expenses and you don’t have to live locally; the St Pancras team in London, for example, stress that they’d be very happy to deal with trial participants from anywhere in the UK.
What about the rest of us?
Although it’s disappointing that those of us with longer-standing CRPS can’t take part in the trial, I still think that overall this is fantastic news. The truth is that this really may be the cure for CRPS; the doctors I spoke to, whilst inevitably cautious, are very hopeful that this may just be the case. And even though they’re limiting participation, there’s still anecdotal evidence coming from Italy that the treatment can be hugely beneficial to people who’ve had the illness for a very long time.
This is the last clinical trial before the drug goes forward for licensing, so if everything proceeds as hoped with the medicine in terms of showing significant benefit to trial participants, we may only be a few years away from this being available on the NHS. In a world where all doctors can do for CRPS sufferers is attempt to manage the symptoms, we are on the verge of having something that is truly a treatment for this hateful illness. And that means that right now the future looks brighter for every CRPS sufferer than it has done ever before. And that’s amazing. Watch this space.