What’s the trial about and how did I get on to it?

I feel I should tell you a bit about the trial and how I got this exciting opportunity to be part of expanding the knowledge of MS and its treatment.

It is a Phase III trial of a drug that it is hoped will slow the progression of Secondary Progressive Multiple Sclerosis. There are approximately 1500 subjects across the world, about 60 of whom are in the UK, spread across several sites. And I am one of them. There is a two thirds chance of being on the drug with the other third on a placebo, and it is double-blind. This means that neither the patient nor the assessing team know who is on it and who isn’t, and how well it works, until the results are compared at the end of the three year trial. Although it is possible to find out if necessary.

By January last year, I was losing the incentive to keep injecting myself with Rebif (beta-interferon) twice a week, or at all. I had been on it for ten years, but now I felt  that it was no longer helping. It used to let me push my limits and get away with it. I’m good at that… pushing my limits. I work on the basis that they change all the time with MS, so if I don’t push them, how do I know where they are? But it wasn’t doing that anymore. And for the last few relapses, things had flared up, got worse and stayed that way. My MS had become progressive rather than relapsing remitting.

That didn’t leave me with many options. Treatment for progressive MS is limited to symptom management, but there is much research. Then my local neurologist suggested he could refer me to a London Hospital, where there was a chance that I was suitable to take part in a trial for something new. It renewed my energy. I started to feel positive again. I had nothing to lose apart from a bit of time and a bit of blood.  And who knows? I might just gain.

Day 7 - Whatever the computer says, I'm not dead

It was a relief to remove the heart monitor which had been stuck to my chest all week, just above my left breast. It had itched madly and finding things to wear that hid it was a nightmare. I’ve only got a few tops with a high enough neckline.

It had accompanying mobile device that was supposed to pick up a signal from the monitor and send it to a computer in the hospital. Or not. Mine didn’t work. The nurse kept ringing me. “We’re not getting a signal. How are you?” “Yes I’m fine, no problems. I’m not dead.”  “That’s good.” I kept resetting it. It worked for an hour then it lost connection again. He told me not to worry, so I didn’t, and when I went up for Day 7, my ECG and vital signs were, of course, normal. I hadn’t had an adverse reaction. They agreed I could continue the trial.

It’s been an interesting experience so far. I’ve had to think hard about my MS history and how it has progressed. But fortunately not too hard. I dug out the copy of it I wrote for my Ill-health retirement application. I just needed to add the few years since then.

I had been fascinated by the cognitive tests. And Alistair, the doctor assessing me, had been full of wonder. “She’s really good as this,” he said to the nurse as he came back for me to draw the six shapes again ten minutes after I’d looked at them. I’d already twice looked at them for ten seconds then drawn them without looking. Could I remember the right shapes in the right places on the page? I’m pleased to report that I scored either very high or almost maximum. I scored high on the adding up test too. That was listening to a list of numbers and adding the last one said with the one before, but not adding them cumulatively. “You made that hard for me,” he said. “You said the answer as the next number was said, then gave that answer too.” I may be physically falling to bits, but my brain still works.

Day 1

So here we are. Day one. The assessments are done. I’m suitable for the trial.

I’ve had an MRI scan, lung function tests, blood tests, cognitive tests, an ophthalmology assessment, a dermatology assessment, ECG, EDSS (Extended Disability Status Scale), a widely used, and often derided, tool for measuring disability in Multiple Sclerosis, and goodness knows what else tests. The works. Good job I get my expenses paid; I’ve been all over the show.

I needed to get to the Research Centre early on Dosing Day 1. First a brief assessment from a doctor to check that I was healthy, then a baseline ECG, BP and pulse before taking the first dose. There were two of us starting the trial that day. Andrew was at the point that I had been at a few years previously, when MS had decided that he needed to stop working, the sick pay was running out and he was entering the minefield that is the benefits system. Although we had both brought a book to read, we spent most of the day talking, interrupted hourly by the nurse coming in to check our BP and pulse in case of adverse reaction. We also had two more ECGs, three and six hours post dose. A drop in blood pressure is a possible initial side effect of starting the drug, should I be in the two-thirds of the group that will be on it. So the dose was titrated (increased slowly) over the first week, during which I would have to wear a heart monitor linked to the hospital.

Finally, eight hours after arriving, we were declared fit to go home. We were issued with a diary to record what time we had taken our tablet each day, along with a card to say we are on the trial which we need to carry with us at all times. The bottle of tablets was put in a bag with an ice block to carry home. It is supposed to be kept at fridge temperature. That’s going to cause some fun on my upcoming trip to Oz.