Double-blind, placebo-controlled study of @entity5305 ( XXXX ) in drug-resistant @entity302 .

@entity1 @entity410 @entity390 @entity5305 @entity146 @entity18125 @entity911 @entity302 @entity1142
@entity5305 ( @entity18125 ) (3 g/day) and placebo were compared as an add-on to standard therapy in therapy-resistant @entity302 @entity1 using a double-blind crossover design with randomized treatment allocation. Twenty-three @entity1 entered the trial, with four dropping out due to either increased @entity410 frequency following the cross-over from GVG to placebo (n = 1), intolerance to GVG therapy (n = 2), or poor @entity410 record (n = 1). Of the 19 @entity1 who completed the study, 17 had partial @entity410 , eight of whom had secondary generalization and two who had primary generalized @entity410 . Compared with placebo, GVG was associated with a significant reduction in @entity410 frequency (p less than 0.01), with 11 of 19 @entity1 experiencing greater than 50% reduction in weekly @entity410 occurrence, two showing a 25-50% reduction, four unchanged, and two showing an increase in @entity410 . Global efficacy ratings were greater in the GVG period for 15 @entity1 (p less than 0.05) compared with one in whom there was no period difference and two in whom ratings were higher in the placebo period. Fourteen of the 19 @entity1 indicated a preference for the GVG period. Adverse effects observed during GVG treatment were generally mild and consisted of drowsiness, @entity911 , @entity390 , @entity146 , and @entity1142 . No clinically significant alterations in laboratory test results were observed. No treatment-related changes in plasma concentrations of concomitant antiepileptic drugs were noted. These results confirm the antiepileptic efficacy of oral GVG in refractory @entity302 .
