There is a trial underway that some people on here would be interested to hear about.
I will try to explain it as best i can. I am on this trial myself.
I have failed on the rebif after 9 years. I did very well on it but i had to come off it as i started to feel very unwell.
The new oral drug ‘Tecfidera’ is being trialled alongside aspirin to see if the aspirin has any effect on the flushing side effects of the tecfidera. They want to find out if taking aspirin can reduce frequency and severity of the flushing side effect of tecfidera.
There are 240 of us on the trial. We are all getting the Tecfidera which has already been trialled and licenced but we all have different doses of aspirin. We are all taking 2 tecfidera tablets a day. The aspirin/placebo has to be taken between 4 and 12 hours appart. The tecfidera has to be taken with food or within an hour of eating. I am allowed to eat what i want.
We have been put into 3 groups. placebo = dummy pill (nothing in it!). so we are having 2 tecfidera + 4 more tablets which are either aspirin or placebo per day.
group 1 = 2 placebo tablets twice a day
group 2 = 1aspirin,1 placebo morning and 2 placebo evening
group 3 = 2 aspirin morning and 2 aspirin evening.
We have an electrical device which is linked to the drug company on which we report our flushing side effects.
Flushing can be redness of skin/warmth/itchy/tingling. We are reporting on severity of flushing/how often flushing happens and for how long episodes last.
I am not allowed any aspirin or simular painkiller for the first part of the trial… I obviously dont know what group i am in.
The above dosage is for the first 4 weeks and then they take you off the aspirin/placebo. So therefore weeks 4 to 8 you are taking the tecfidera on its own.
From week 9 i can decide by myself if i want/need to take aspirin with my tecfidera. I will fill in a diary of what i am taking and any side effects.i experience.
I have to see the trial team at weeks 0,4,8,12,24,36 and 48.
I have questionaires to fill in about how i am feeling/side effects and how my ms is bahaving… I am being weighed/blood tests/urine samples. There is NOTHING they don’t know about me now!!! ha ha!! I must not get pregnant on the trial.
I will be monitored closely for 48 weeks.
This is a brief outline of the trial. Hope it’s been helpful.
I am doing very well so far with just a bit of flushing. I have no stomach problems so far. I am on week 6 so am on just the tecfidera on its own part of the trial.