Randomised Controlled Trial on Sodium Valproate and Levetiracetam in Children with New-Onset Epilepsy

To compare the efficacy of sodium valproate (VPA) and levetiracetam (LEV) as initial maintenance monotherapy in children with new-onset epilepsy.

This randomised controlled trial was conducted in tertiary pediatric epilepsy and neurology clinics. Children 2-18 y with new-onset epilepsy were enrolled as participants. Patients were prescribed VPA (n = 58) or LEV (n = 58) at 20 mg/kg/d in two doses with increments of 20 mg/kg/d to a maximum of 60 mg/kg/d (Maximum daily dose: VPA 2 g/d and LEV 3 g/d). Primary outcome was the proportion of patients who achieved seizure control for three consecutive months. Secondary outcomes included the proportion of patients who achieved a 50% reduction in seizures from baseline and those who developed side-effects.

A total of 116 patients were analysed using intention-to-treat analysis. There was no difference in the primary outcome between LEV vs. VPA groups [58.6% vs. 65.5%; relative risk (RR) 0.89 (95% CI, 0.67-1.19), p = 0.444]. There was no difference in patients who achieved a 50% seizure reduction from baseline between the two groups (70.7% vs. 70.7%) and side-effect profile (32.8% vs. 46.6%, p = 0.128) other than median (IQR) weight gain (kg), which was significantly lower in the LEV group (1.35, 0.70-1.60) as compared to the VPA group (2.15, 1.40-2.60) (p < 0.001). One patient in the VPA group had Stevens-Johnson syndrome. No mortality occurred.

No difference was noted between sodium valproate and levetiracetam in seizure control. With a favorable side-effect profile, levetiracetam can be safely considered as initial maintenance monotherapy in children with new-onset epilepsy.