Epilepsy Outcome at Four Years in a Randomized Clinical Trial Comparing Oral Prednisolone and Intramuscular ACTH in West Syndrome

Pediatr Neurol. 2021 Jun;119:22-26. doi: 10.1016/j.pediatrneurol.2021.01.008. Epub 2021 Mar 8.


Background: This article explores the role of initial treatment on control of spasms and other epilepsies at four years in children previously treated for West syndrome.

Methods: The Sri Lanka Infantile Spasm Study is a prospective clinical trial evaluating response to intra-muscular adrenocorticotropic hormone (ACTH) versus oral prednisolone. A previous report documented response through age 12 months. This article provides four-year follow-up data.

Results: At age four years, 65 of the original 97 were available for follow-up; another 13 had died, and 19 moved and could not be contacted. Of the 65 children, 37 (57%) continued to have seizures and 28 were seizure free. In the 37 children with ongoing epilepsy, 32.4% continued to have spasms, either alone or in combination with other seizure types. The epilepsy types seen in these children were focal epilepsy (59.4%), mixed focal and generalized epilepsy (24%), generalized epilepsy only (10.8%), and uncertain (5%). The majority of those still having epilepsy (66.7%) were controlled on medication. There was no significant difference in the rate of epilepsy or spasms or their control by medication between those treated with ACTH or oral prednisolone. Spasm control at day 14 did not influence the four-year spasm or epilepsy outcome.

Conclusions: A majority of children diagnosed with West syndrome continued to have seizures at age four years, although most were controlled on antiseizure medication. The long-term risk of developing epilepsy or its control was the same, regardless of whether ACTH or prednisolone was initially used as treatment.

Keywords: ACTH; Epilepsy; Epileptic spasms; Infantile spasms; Outcome; Prednisolone; West syndrome.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adrenocorticotropic Hormone / administration & dosage
  • Adrenocorticotropic Hormone / pharmacology*
  • Child, Preschool
  • Female
  • Follow-Up Studies
  • Glucocorticoids / administration & dosage
  • Glucocorticoids / pharmacology*
  • Humans
  • Infant
  • Injections, Intramuscular
  • Male
  • Outcome Assessment, Health Care*
  • Prednisolone / administration & dosage
  • Prednisolone / pharmacology*
  • Spasms, Infantile / drug therapy*


  • Glucocorticoids
  • Adrenocorticotropic Hormone
  • Prednisolone