Melatonin as an add-on anti-seizure medication in children with epilepsy: An open-label randomized controlled trial

The primary objective of this study is to measure the effect of melatonin in decreasing seizure frequency in intervention group as compared to controls in children with drug-resistant epilepsy. An open-label randomized controlled trial was conducted from July 2020 to June 2022 in children between 2 and 14 years with drug-resistant epilepsy attending Pediatric and Neurology outpatient department and inpatient department. After noting down baseline seizure frequency, children were randomized into the melatonin group and control group. In the melatonin group, add-on melatonin was added to the existing ASM, and in the control group, ASMs were continued. The primary and secondary outcomes were measured after 3 months of follow-up. The percentage change in the seizure frequency between both groups at the end of 3 months of follow-up was not statistically significant, but the percentage reduction of seizure frequency was more than 50% in the melatonin group. Melatonin was well tolerated in our children except for 4 (22%) who developed minor adverse effects. Add-on melatonin decreases seizure frequency to some extent which was not statistically significant with no major side effects. Further studies are needed to assess add-on melatonin’s long-term effectiveness and safety in children with drug-resistant epilepsy.