drugset
drugset / Trial / NCT02299115

Prednisolone Versus Vigabatrin in the First-line Treatment of Infantile Spasms

NCT02299115 ↗

Phase 3 Withdrawn The Hospital for Sick Children
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2017-09-05
Primary completion
2019-03-06
Completion
2019-03-06

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Prednisolone Other / unclassified — Oral
Comparator Vigabatrin Small molecule — Oral

Indications

infantile spasms