Intravenous Methylprednisolone Versus Oral Prednisolone for West Syndrome: A Randomized Open-Label Trial.

To compare intravenous methylprednisolone (IVMP) with oral prednisolone (OP) for the treatment of West syndrome. In this randomized, open-label trial, children aged 2 to 30 mo presenting with epileptic spasms with hypsarrhythmia or its variants on EEG were randomized to receive either IVMP (30 mg/kg/d for 3 d followed by oral prednisolone taper) or OP (4 mg/kg/d for two weeks followed by taper). The primary outcome measure was spasms cessation on day 14. Secondary outcomes included time to response, electroclinical remission at 2 and 6 wk, and frequency of adverse effects. ( ClinicalTrials.gov Identifier: NCT 03876444). Sixty children were enrolled; 31 in the IVMP and 29 in the OP arm. Proportion of children achieving spasms cessation at day 14 was similar in both groups (54.8% versus 68.9%, p = 0.26). Time to achieve remission was lower in the IVMP group (mean 5.4 ± 0.9 versus 9.5 ± 2.6 d, p < 0.0001). Electroclinical remission at 2 wk was similar in both groups (51.6% versus 44.8%, p = 0.59) but lower at 6 wk in the IVMP group (45.2% versus 75.9%, p < 0.015). Adverse effects like sleep disturbance, irritability and hypertension were more common in IVMP group whereas weight gain was more common in the OP group. There was no significant difference in spasms cessation between the groups on day 14 although remission was higher at 6 wk in OP group. Our study suggests that OP was better than IVMP in efficacy and sustained remission with fewer adverse effects.