Should I participate in MS Trial Or Not? BG112 Oral Meds Posted: 10-16-07 05:23am
Hi all!
My neuroligist has givein me the option of
partaking in the trial outlined below. Im
24 n was told i had MS about 4years ago
after i got blurred vision (optic
neurities), i was takeing beta-interferon
for about 3 years and he advised me that i
could take a break for awhile around
6months ago as i was starting to have some
discomfort wit injection sites. iv been
off it now for 6 months and so am an ideal
candidate for these trials (nothing in the
system). The problem is that im starting
to feel like he only told me to take this
break so i could go ahead with the trial.
im pure confused as to if i should do it
or not. cant find any info on this BG112,
all i know is that it is in tablet form
which sounds fantastic to me! the copaxone
is an injection which wouldnt be the end
of the world as i wouldnt be any better or
worse off than i was 6 months ago! if
anyone can give me any info/advice id
really appreciate it! (The neuroligists
e-mail to me is below)
Thanks,
John
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John
The trial is of an agent called BG112 (it
hasn't got a 'real' name yet) which is an
oral medication that is being tested in
MS. The early studies (Phases I and II)
have already been done showing promise for
this drug and the study we hope to be
involved with is the Phase III - the last
hurdle before the drug is approved for
usage. It is a randomised controlled
trial. This means that any volunteer or
their doctor cannot choose the treatment
they receive. If they agree to go into the
study they can be 'randomised' to receive
either the new treatment or the older
treatment to which it is being compared.
If that process is not randomised the
results may not be accepted by the
scientific world as that would have
introduced a 'bias' into the results. The
advantages of taking part in a trial are
that you might receive the new treatment
and that you are monitored very closely -
usually every 6-8 weeks throughout the
trial and afterwards. You are also helping
to test this new treatment for other
people. The disadvantage is that you must
accept the randomisation at the start of
the trial which means you might get the
new treatment or the treatment it is being
compared to. Sometimes the comparison is a
placebo, i.e. no treatment at all just a
'coloured pill'. In this trial the
comparison is between BG112 and the older,
already established treatment of Copaxone
which is already shown to be of benefit.
If the person's condition deteriorates at
any time during the trial the patient and
the doctor are entitled to withdraw from
the study and go ahead with whatever
approved tried and tested treatment is
available.