Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures.

ABSTRACT:

Objective

To evaluate the efficacy and safety of adjunctive topiramate (sprinkle capsules or oral liquid) in reducing daily rates of partial-onset seizures (POS) in infants with refractory POS.

Methods

In this double-blind, placebo-controlled, parallel-group, international study, infants (n = 149) with clinical or EEG evidence of refractory POS were randomly allocated (1:1:1:1) to receive adjunctive topiramate 5, 15, or 25 mg/kg/d or placebo for 20 days. The primary variable was the median percentage reductions in daily POS rate from baseline to final assessment as recorded on a 48-hour video-EEG.

Results

Of the 149 infants (mean age 12 months) included in the intent-to-treat analysis set, 130 completed the study. Median percentage reduction from baseline in daily POS

SUBMITTER: Novotny E 

PROVIDER: S-EPMC2836871 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature