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From Medhelp:
sorte
In clinical trials, birinapant has been associated with the onset of cranial nerve palsies, meaning a weakness or paralysis of the areas served by the affected cranial nerve. Across the entirety of the clinical program to date, there have been 18 cases of cranial nerve palsy, of which all but two have been mild to moderate in severity. These events have been transient and responsive to therapy. Some subjects who reported a cranial nerve palsy elected to continue birinapant treatment, and none had a recurrent event of cranial nerve palsy.
The majority of events have affected the VII cranial nerve and caused a Bell’s palsy, i.e., a weakness affecting one side of the face. All but one case of Bell’s palsy has occurred in subjects receiving a weekly cumulative dose of birinapant of 22mg/m2 or higher. However, one event was reported in a subject receiving a cumulative dose of 4.2mg/m2. The onset of Bell’s palsy typically occurs after the third dose of birinapant and is preceded by a prodromal syndrome of headache, ear or eye pain. Thus, we believe it may be possible to mitigate the onset of the cranial nerve palsy by intervening with either non-steroidal anti-inflammatory drugs ( NSAIDs) or corticosteroids at the time of the prodromal syndrome and deferring the next dose of birinapant. This procedure is being implemented in all of the clinical programs.
http://ir.tetralogicpharma.com/s ... 370-15-186&cik=
stef2011
3 hours
To: 80percenthidebrain
it all depends if it can be recovered easily, prevented, controlled
if we consider hcc treatment you can bear sides like that if the other choice is death....if it is to clear an inactive hbv it must be a reversible side
studyforhope
2 hours
The Bell's palsy caused by BIRINAPANT is not the same as regular spontaneous Bell's palsy. It will typically disappear fast upon discontinuation of the drug. Methyl cobalamin injections will speed up recovery and might possibly have preventative effects. However i doubt that the situation is handled this way.
We do not know at which dose level and what frequency this problem occurred. One can only hope that the trial will continue after it has cleared up.
sorte
2 hours
thanks man !! the part hope in your nickname is well deserved, study as well btw 
twinboys1girl4me
1 hour
To: studyforhope
Good to know. This initially worried me as I do know someone that got Bell's out of the blue and is still completely debilitated for over 2 years now, without much improvement and tons of therapy.
Do you think they will restart the trial if others want to go forward, or do you think the FDA will shut it down? You are very knowledgeable and I am very new to the background of how trials function. I was really hoping for great news from this one, as I know we all were. Let's just hope it's not a complete wash.
studyforhope
11 minutes
To: twinboys1girl4me
it is hard to predict how the fda will react. the recovery process from the palsy and speed will also determine that. it should only take 2 weeks to recover, but i dont know if they will use methylcobalamine to speed up recovery.
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楼主: StephenW
发表于 2015-5-7 04:25
