Combination Therapy With Vigabatrin and Prednisolone Versus Vigabatrin Alone for Infantile Spasms.

ABSTRACT:

Objective

The study evaluated the effectiveness of combination therapy with vigabatrin and prednisolone versus vigabatrin alone for treating infantile epileptic spasms syndrome (IESS).

Methods

This single-center, single-blind, randomized trial enrolled infants aged 2-14 months with new-onset IESS, randomly assigned them (1:1) to receive either combination therapy with vigabatrin (100-150 mg/kg/day) and prednisolone (40-60 mg/day) or vigabatrin alone. The primary outcome was sustained spasm remission between days 14 and 42. The trial (ClinicalTrials.gov identifier) was terminated early due to an interim analysis revealing a significant difference between treatment groups.

Results

In all, 17 infants were assigned to combination therapy and 24 to vigabatrin alone. The me

SUBMITTER: Boonkrongsak R 

PROVIDER: S-EPMC12093345 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature