end of my FTY720 phase lll trial and beginning of ...

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end of my FTY720 phase lll trial and beginning of ...

Postby carolew » Sat Dec 06, 2008 10:09 am

the extension phase.
This week was so packed with all kinds of appointments... :roll:
the eyes twice, the lungs, the heart, 2 neurologists, dermatologist, MRI, my work schedule... I skipped my wine course....it was too much....
That week was scary... but now, next week , I start the extension phase. They keep me under observation for 6 hrs again...
I will get either 1.25 mg or 5 mg of the FTY720. No one will know until sept. 09. I will give it a try and if after a few months, I continue to deteriorate, I will ask for something else.
I am afraid of stronger drugs because I want to be able to continue to work.
I will keep you posted.
I have almost quit my exercise routine... lack of motivation... I have to go back to it....just can't do it so regularly now.... anyway, hope you are well... take care , Carole
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Postby Lyon » Sat Dec 06, 2008 10:28 am

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Last edited by Lyon on Sun Nov 27, 2011 12:02 pm, edited 1 time in total.
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Postby mjs » Sun Dec 07, 2008 4:00 pm

I thought they'd given up on the 5mg dose - and that the 1.25mg was just as effective (with less symptoms)....?
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Postby carolew » Mon Dec 08, 2008 5:02 am

I read also on here that the smallest dose was as effective but the extension phase still compares the two doses...For the longest time, I thought I was on placebo until my lymphocytes came back below normal at my annual check up. The new pill starts Wednesday the 10th of dec. therefor I don't have to wait too long. I am looking forward to it.
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Postby dignan » Mon Dec 08, 2008 9:07 am

I think the phase 3 trials are testing 1.25mg vs. 0.5mg. The 5.0mg dose isn't part of phase 3 at all from what I've read.
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Postby carolew » Mon Dec 08, 2008 5:08 pm

I am reading the protocol of the study now and it is confusing. They say that if you were on 5 mg in the core study... you stay on that dose. Then they say they are testing 1.25mg against 0.5mg... ? Then, if I read the protocol of the core study... they clearly state that they were testing 1.25 against 0.5 mg... I think they used 5 mg in the phase l trial and that I may be getting confused. I do believe the extension study, will be of 0.5 against 1.25mg.... I they may have made a mistake or made things unclear for me.... I will ask the study people again... will tell you later... take care, Carole.
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Postby CureOrBust » Mon Dec 08, 2008 7:05 pm

I think you are right, in that the new study (Phase III) was at the two lower doses (ie 1.25mg & .5mg). I remember applying for this trial, and that detail stuck in my head at the time. I looked for the original documents provided to me by the study neuro, but didn't find them, so didn't post.

I checked the clinical trials web site, and confirmed it there.

A 24-Month Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Versus Placebo in Patients With Relapsing-Remitting Multiple Sclerosis
http://www.clinicaltrials.gov/ct2/show/NCT00355134?term=multiple+sclerosis&rank=23
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Postby carolew » Wed Dec 10, 2008 9:18 pm

ok, I have started the drug for real. I spent 8hrs at the hospital today and stared the prolongation study. It is between 0.5 and 1.25mg.
Funny thing happened. There was another lady on the study there and she too, thought that she had been on placebo the whole time because she got worse and had no side effect what so ever.... Will give it a few months and will reevaluate... take care, Carole
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Postby dignan » Wed Dec 10, 2008 10:27 pm

Carole, thanks for the update. I really hope you have no MS activity at all now that you're on the real deal.
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Postby carolew » Thu Dec 11, 2008 8:23 am

thanks Dignan, I will be able to answer that in a few months....
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