Purpose: To compare the cognitive and behavioural effects of clobazam versu
s standard monotherapy in the treatment of childhood epilepsy. Methods: A r
andomized, double-blind, prospective design was carried out at three Canadi
an pediatric epilepsy centres. This study was part of a larger multi-centre
study on the efficacy of clobazam. Children with newly diagnosed epilepsy
were assigned randomly to receive clobazam or carbamazepine. Children who h
ad failed previous treatment with carbamazepine were assigned randomly to c
lobazam or phenytoin. Children who had failed on any other antiepileptic dr
ug were assigned randomly to receive clobazam or carbamazepine. In a subset
of patients neuropsychological assessments were carried out at 6 weeks and
12 months after initiation of medication. Intelligence, memory, attention,
psychomotor speed, and impulsivity were assessed. Results: There were no d
ifferences between the clobazam and standard monotherapy groups on any of t
he neuropsychological measures obtained at 6 weeks or 12 months. There was
no evidence for a deterioration in performance for those children who remai
ned on clobazam for the entire 12-month study period. Conclusion: The cogni
tive and behavioural effects of clobazam appear to be similar to those of s
tandard monotherapy. (C) 1999 Elsevier Science B.V. All rights reserved.