Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms
Status:
Withdrawn
Trial end date:
2019-03-06
Target enrollment:
Participant gender:
Summary
Infantile Spasms, is an rare age-specific epilepsy of early infancy. A 2012 American Academy
Neurology/ Child Neurology Society practice parameter update on the medical treatment of
infantile spasms concluded: adrenocorticotrophic hormone or vigabatrin may be offered for
short-term treatment of infantile spasms. There was insufficient evidence to recommend the
use of prednisolone, dexamethasone, and methylprednisolone. The cost of ACTH and the side
effects of vigabatrin have led to the consideration of alternative medications to treat
infantile spasms. The United Kingdom Infantile Spasms Study (UKISS) in 2004, comparing the
efficacy of intramuscular synthetic ACTH to high dose oral prednisolone, showed a response
rate of 74% for ACTH and 70% for prednisolone. Since the UKISS paper was published, many
institutions in the United States and Australia have used oral prednisolone instead of ACTH,
partly due to the exorbitant cost of intramuscular ACTH but also its ease of use and better
adverse event profile compared to ACTH. Prednisolone and vigabatrin are both oral
medications, which can be initiated promptly upon diagnosis of infantile spasms, expediting
treatment and shortening treatment lag time. Because the UKISS trial is the only Class 3
study providing evidence for oral prednisolone in the first-line treatment of infantile
spasms, further prospective studies are needed.