Evaluation of efficacy of add on oral Magnesium to standard therapy in children with Infantile Epileptic Spasms Syndrome aged 2-24 months: Open-labelled randomized controlled trial

Infantile Epileptic Spasms Syndrome is a severe developmental and epileptic encephalopathy of infancy that requires early and effective treatment to improve seizure control and neurodevelopmental outcomes. Standard first-line therapy includes hormonal treatment with oral prednisolone and vigabatrin. A substantial proportion of children have incomplete response or experience treatment-related adverse effects. Magnesium is an essential regulator of neuronal excitability and acts as a physiological N-methyl-D-aspartate  receptor antagonist. Emerging evidence suggests that magnesium supplementation may have an adjunctive role in improving seizure control and electroencephalographic outcomes in children with IESS, but data on oral magnesium therapy remain limited. This study is an open-label, parallel-group randomized controlled trial conducted at a tertiary care center. Children aged 2–24 months with newly diagnosed IESS will be randomized to receive either standard therapy alone with oral prednisolone and vigabatrin or standard therapy with add-on oral magnesium sulphate for four weeks. The primary outcome is spasm cessation at four weeks. Secondary outcomes include change in spasm frequency, EEG improvement using the BASED score, developmental and behavioural outcomes, serum magnesium levels, and adverse effects.