drugset / Trial / NCT06819670

A Study to Prevent Infantile Spasms Relapse

NCT06819670

RandomizedFactorialQuadruple-blindPrevention

Summary

After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.

Timeline

Start
2025-05-05
Primary completion
2028-02-28
Completion
2028-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Famotidine Other / unclassified 1 mg/kg
Comparator Prednisolone Other / unclassified 1 mg/kg

Indications