I am dx with rrms and am currently waiting to be enrolled in a clinical trial for an oral dmd. This is being run by my neurologist and based at a second hospital. I just wondered if many others have been involved in clinical trials, what your experiences were/are? Also if there are any questions I should be asking? Or things I should take into consideration before committing 100%. Thanks.
I participated in a clinical trial that took only 6 months, between May and November last year. I was diagnosed in February 2012 after a thankfully short investigation period which involved MRI and LP (I had first symptoms in November 2011). I was on a “wait and watch” period after diagnosis for almost a year (before I changed hospitals after moving home), but had discussed treatment, including the possibility of clinical trials with my new neuro when I met him in January 2013. I heard about the trial during the MS Research Day (February 2013) and immediately volunteered as my attitude was (and is) “nothing ventured, nothing gained”.
The positive things about being on the trial (although the protocols for other trials will probably be different, as will the duration) were many:
I had a monthly assessment by the lead neuro, which included EDSS scoring
A monthly brain (though not spine) MRI
I was able to contact the trial co-ordinator and the neurologist at any time I had a question (it was all so well explained and I felt so supported, I didn’t have any)
I was reminded that I could opt-out at any stage (I relapsed during the trial and it was pointed out on many occasions that I could leave the trial and start a DMT) and it was stressed constantly that my health was the important thing.
The only potentially negative thing was that whilst I was on the clinical trial I wasn’t on a DMT, but at the time I was only eligible for first line DMTs and I wasn’t particularly impressed with what they offered. As a result of the trial and the monthly MRIs, there was proof that I had highly active MS, so once the trial was completed, my neurologist applied for Tysabri for me and I have been on it since the end of November.
As an aside, I found that being on the trial also lifted my mood as I felt I was contributing something to the fight against this bl00dy disease! We all want the doctors and researchers to magic us a cure, but without some of us volunteering to be guinea pigs, it is very difficult for them to progress. My attitude is that even if a clinical trial does not prove the hypothesis and so does not directly translate to a cure, by helping them to cross off questions and theories from the list of possible cures, we are helping to narrow the focus and one day there will be a cure, whether in our lifetimes or later.
I was on the Fingolimod trial (now Gilenya), from 2010 and my experience was very similar to LooLaa’s.
If your neurologist and the trials team didn’t think you were a potential candidate who could benefit then you wouldn’t have been invited to take part, so they think that this new drug would be beneficial to you and those in a simlar position.
I had regular check-ups with the trial team and various doctors and specialists to check that everything was working the way it should: poked, prodded, bled dry, scanned, pushed, pulled and generally very well looked after. And if something came up that was new or unexpected then it was straight to the relevant department to find out what it was, why it happened and would it happen again.
You also need to be aware that they might take you off the trial if something isn’t right. My liver function was completely screwed for a couple of months and they came close to taking me off because of that, so you will be well properly cared for and they won’t just experiment on you regardless of what happens.
Overall they looked after me exceptionally well, and they also paid my expenses which I used to buy them lots of cupcakes - if someone’s going to be sticking needles into me month after month then I want them to be well fed and feel appreciated!
I think id be looking into whether or not you could be given a placebo, if this is the case you could be on nothing, and that might not suit you. Garry are you still on gilenyn and how have you found it, people are just being offered this and it would be really good to hear experiences. X
Thanks all, it’s really helpful to hear your experiences. They sound largely positive! It’s not a blind trial so no chance of placebo, which is goo as I’m anxious to take something. Think it will feel good to do something purposefull for a change. Thanks for your input.
I am and haven’t had any really serious relapses for over 18 months. It also seems to have slowed the progression because the number of smaller relapses has dropped and my day-to-day symptoms seem to be behaving themselves! Again, it could just be coincidence because there’s no real way of knowing until you look at the long-term trends.
I was on Rebif and that really srewed up my liver so had to stop*,* and while my liver function results are still elevated they’re nowhere near as bad as they were on Rebif. Get the occassional moment when they shoot up, so I still get my blood taken regularly to check.
Biggest issue I have is with colds and coughs; because Gilenya’s an immuno-suppressant whenever I catch a cold it can take 3/4 weeks to clear instead of 3/4 days. A couple of bacterial infections that have taken horse-strength antiobiotics to clear. I also started getting regular migraines a month after I started taking Gilenya, but that could have been coincidental as none of the investigations the hospital carried out could find a link. I haven’t had any for 4/5 months (touch wood), so hopefully it was just a phase.
All in, it’s been a really positive experience and if I get 2/3 months back each year then that could be 120 months over the next 40yrs, which is an extra 10yrs of life! I really recommend trials because if we never tried anything new then we’d still be in the dark ages…
I have been on Gilenya for almost 3 years now (started when I was in Australia)
In that time I have had no relapses or progression but have had a couple of new lesions
When I started I had some chest pain and shortness of breath but these all resolved themselves
I would recommend it