A Randomized Controlled Trial of Phenobarbital and Levetiracetam in Childhood Epilepsy

Levetiracetam has been introduced for the control of seizures besides phenobarbital as monotherapy in children with epilepsy. This study was aimed to compare the effectiveness of these two drugs for the control of seizures in epilepsy. This randomized controlled trial was done to assess the efficacy and tolerability of levetiracetam compared to phenobarbital in childhood epilepsy and was conducted in Institute of Pediatric Neurodisorder and Autism (IPNA), Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka, Bangladesh among children between 1 month to 15 years who were diagnosed as cases of epilepsy (idiopathic focal, generalized, focal with secondary generalization) according to ILAE to assess the effect of Levetiracetam (n=50) and Phenobarbital (n=68) from May 2015 to July 2016. The children were followed up for 12 months at 3 months interval to compare the seizure remission and side effects of Levetiracetam and Phenobarbital. The children in levetiracetam group was about 10 months older along with older age of onset of seizure (p=0.02) than those of phenobarbital group (p=0.03 and 0.02 respectively). GTCS was the most common type of seizure in both groups. During 3 months of intervention 55.8% patients of levetiracetam group achieved 50-75% seizure remission compared to 44.2% in phenobarbital group, at 6 months period 75-100% seizure remission observed among 57.4% patients of levetiracetam group compared to 42.6% of phenobarbital group (p=0.06), which continued to increase at 9 months in levetiracetam (n=33, 55.9%) compared to phenobarbital (n=26, 44.1%) and this value is statistically significant (p=0.05). No further improvement observed at 12 months follow up. Behavioral problem was reported among 4 patients of phenobarbital group without any evidence of cognitive deterioration, only 3 patients of levetiracetam experienced irritability, but no children of both group discontinued treatment due to side effects. Levetiracetam mono-therapy is more effective in controlling seizures in focal, generalized and focal with secondary generalization epilepsy compared to phenobarbital with minimum side effects.