Phase III: Dexpramipexole

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I remember reading some where that all the participants would get the real medicine at the end of the trial. Has anyone else seen this and remember where? Also, I understand that the trial was closed as of Aug. 31, 2011. Does it means their 12 month trial period would end in something like Aug. or Sept. 2012 and all folks would get the real medicine from that time onward. TIA


I believe that they are planning a phase III B to start this spring, so the trial is far from over.
 
I think they're increasing the dosage (doubling it?) for the new Phase 3B... but the original phase 3 is supposed to end around this Sept. Curious as to whether they'll continue the part A part and give everyone the meds and keep monitoring us all.
 
The clinic said the end is Sept and then we get the real meds. The next trial is double this trials dose. I think it's 600mg.
 
Has anyone been hearing anything about untolerable side effects?
 
Anybody had thrush and high liver counts?
 
Re. thrush and liver abnormalities. I had rash problems early on in the study but the rash cleared up with meds. Also, first lab work indicated lowered white blood cell but the count reverted to normal at the next blood draw. My CK levels continue to be about twice the normal rate but I understand that is normal for PALS. I am so, so pleased to have been able to be admitted to this study ! ! !
 
Hi All, went to month 8 of the Dex trial yesterday... blood draw, muscle and breathing tests, etc.

Interesting discussion about the "phase 3B" of the Dex trial... seems that it MAY be on hold for now. Evidently it was applied for pretty quickly, yet nothing has been heard about the criteria? Not sure I'm saying this correctly, but it seems that either some of the data they want gathered may be changed and that is delaying it, or may not happen at all. Don't know for sure at this point, but it WAS expected to have started already for the next phase.
 
We head over to Mayo next Fri. for month 6. Shes pretty sure shes on placebo. We were diagnosed in May and stared trial in aug, so we really cant judge if progression slowed or not. We really didn't have much of a baseline.
 
Spoke with Neurologist here in the UK today and he doesnt expect the the DEX trial to start again untill October.The reason given for this is that the data from phase 2 has not been followed yet.
 
That should say collected
 
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