Tecfidera/aspirin trial

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.


Yes anon!

Back to condoms which i am informed have to be used with spermicide!

I was hoping it would force my hubby to have the snip but he seems to have gone very quiet on this subject!


okay… let’s divert the topic of coversation away from bollock chopping and back onto the aspirin trial, which, sounds awesome!

one might hope that seeing as you have some flushing now, being at week 6, you will find out that you have been munching white smarties instead of aspirin; the trial hypothesis being that any flush blushes are transitory and can be easily managed as your body grows accustomed to the new drug regime?

are all participants brand new tecfidera users, presumably having the half dose for the first 7 days before going up to the full 480mg daily?

LOL! chopping of a certain part of the anatomy is also an awesome subject! ha ha ha!!

We are all new tecfidera users. Starting with the 120mg dose for the first week and then up to 240mg for the rest of the trial.

Is there a 480mg dose? I didn’t know about it if there is!!! or are they going to give me that later on in the trial? - they have not mentioned it. I thought 240mg was the full dose?

Are you on tecfidera Paolo?

Perhaps i need to investigate the dosages.

Silly me!!! my excuse is that it’s late and i am tired now!

I understand what you meant now! you mean 480mg as 2 x 240mg tablets each day!

It took me a while at this time of night…i think i better go and sleep now…zzzzzzzzzzzz!!!

I am hoping to start Tecfidera in late Autumn. Rebif made me too poorly and Copaxone, although it has been great has caused damage to fat layer. After one year one site was no longer usable and four more sites showing signs of going the same way…sooooo shall be watching to see how trials go for Tecfidera and crossing my fingers side effects can be managed this time!

Hope side effects not too bad for you.

mish x

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Thank you for this post Teresa - it’s really useful

jane x

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