Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
Status:
Recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
Infantile spasms (IS) are seizures associated with a severe infantile epileptic
encephalopathy. Both cessation of spasms and electrographic response are necessary for the
best neurodevelopmental outcomes. Adrenocorticotrophic hormone (ACTH), or prednisolone, or
vigabatrin are considered the first-line treatment individually. However, ACTH expense and
availability are the barriers in developing countries including Thailand. Vigabatrin,
therefore, is the first recommended by Epilepsy Society of Thailand due to ACTH
unavailability. Recently, combined steroid treatments (either ACTH or high dose prednisolone)
with vigabatrin are superior in cessation of spasms compared to steroid treatment alone.
Thus, this study is aimed to compare the efficacy of vigabatrin with high dose prednisolone
combination therapy and vigabatrin alone.