A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

What this Trial Is About

Researchers are investigating how to prevent relapse in infants with Infantile Epileptic Spasms Syndrome (IESS) who have responded to standard treatment. This study aims to find out if low-dose prednisolone is safe, well tolerated, and can reduce the risk of relapse, which is linked to poor long-term outcomes like autism and other types of epilepsy. The study is a Phase 2 randomized clinical trial with a quadruple-blind design conducted by the University of California, Los Angeles. Participants will be randomly assigned to receive either low-dose prednisolone with famotidine or matching placebos for 4 months. During the first 7 months, patients will have monthly clinic visits including electroencephalography (EEG) to monitor their condition. After this period, they will have a final evaluation at age 2 years to assess relapse, development of other seizures, and behavioral outcomes. The study also evaluates the feasibility of the treatment and study procedures. Throughout the trial, infants will be closely monitored for any treatment-related side effects and for relapse of epileptic spasms. Researchers will assess developmental and behavioral status at age 2 years and track the incidence of autism spectrum disorder. Safety is monitored from enrollment through the 5-month visit, and participants are followed until their last evaluation at age 2 years. Total participation lasts until the child reaches 2 years of age, with regular visits and assessments to ensure careful observation.

A Study to Prevent Infantile Spasms Relapse