A Randomized Controlled Trial on the Study of Effectiveness and Safety of Hormonal (ACTH) Treatment Alone versus Hormonal (ACTH) with Levetiracetam for Epileptic Spasms.

West's syndrome (WS) is a triad of epileptic spasms (ESs), psychomotor delay, and hypsarrhythmia. The treatment of ESs is still controversial. Hence, we designed a randomized controlled trial (RCT) to compare the outcomes in children with WS treated with adrenocorticotropic hormone (ACTH) alone versus ACTH and levetiracetam (LEV).  To compare the treatment outcomes and side effects in children treated with ACTH alone versus ACTH and LEV.  This prospective randomized controlled trial was conducted from December 2017 to May 2019 in tertiary care center, Bangaluru. Children from 2 months to 5 years of age, diagnosed with WS were included. Fifty children in each group were analyzed for efficacy and side effects.  There was no difference in the baseline characteristics in both groups. There was no difference in spasms response at the end of 2 weeks between the groups (88 vs. 82%) with -value of 0.813. The relapse rates were less in ACTH and LEV group (20%) compared with ACTH alone (22%) but statistically not significant (  > 0.1). There was no difference observed in subsequent epilepsy rates (18%) in ACTH versus 19% in ACTH with LEV group (  > 0.1) and side effects. There was improvement in milestones 48% in ACTH with LEV group versus 37% in ACTH alone however statistically not significant (  > 0.1).  There was no difference in children treated with ACTH alone versus ACTH and LEV in terms of control of spasms and subsequent epilepsy rates. The relapse rate is less, and developmental outcome is better in ACTH with LEV group but statistically not significant.