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TRANSLATE

Monday, October 14, 2013

SAFINAMIDE CLINICAL TRIAL RESULTS



6th September 2013 - New research


European Journal of Neurology [2013] September 11 [Epub ahead of print] 
 (A.H.Schapira, F.Stocchi, R.Borgohain,
 M.Onofrj, M.Bhatt, P.Lorenzana, V.Lucini, R.Giuliani, R.Anand) 



Safinamide is believed to have both dopaminergic and non-dopaminergic 
actions, including the inhibition of MAO-B and inhibition of glutamate release. 
It is undergoing  Phase III clinical development as a once-daily add-on to
 dopamine agonists for the treatment of early Parkinson's Disease.


In a one year clinical trial people with Parkinson's 
Disease received 100mg or 200mg Safinamide daily. 
They were assessed according to how long it was 
 before they had to increase their dopamine
agonist dose 
or add another Parkinson's Disease treatment. 
People receiving 100 mg/day safinamide experienced 
a significantly lower rate of intervention compared with placebo, of 25% 
instead of 51% and a small delay before the need to increase other
 Parkinson's Disease treatments of 9 days.
In a previous study of once daily dosages of 50mg to 100mg Safinamide
 improved Parkinson's Disease symptoms after six months and reduced
 "off" time when added on to the use of existing Parkinson's Disease 
treatments. However, the reduction in "off" time in comparison to
 the use of a placebo was minimal. The increase in "on" time beyond 
that of a placebo was only 40 minutes for 50mg safinamide, and 50 minutes 
for 100mg safinamide.

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