Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm

Launched by KULLASATE SAKPICHAISAKUL · Mar 6, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how effective a combination of two treatments—vigabatrin and high-dose prednisolone—is for treating infantile spasms, a serious type of seizure disorder in babies. The goal is to see if using both treatments together works better than using vigabatrin alone. Infantile spasms can significantly affect a child's development, so finding the best treatment is very important.

To participate in this trial, children must be between 2 to 14 months old and diagnosed with infantile spasms by a pediatric neurologist. They also need to be Thai nationals. However, children who have been treated with vigabatrin or steroids in the last 28 days, or who have certain other health conditions, cannot join. Families interested in this study can expect regular check-ups and support throughout the trial. It's important to note that this study aims to provide more accessible treatment options for families in Thailand, especially since some treatments can be expensive or hard to find.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age at 2-14 months at date of enrollment
• • Clinical diagnosis of infantile spasm assessed by pediatric neurologist and hypsarrhythmic pattern or variants interpreted by pediatric epileptologist
• • Thai nationality
• Exclusion Criteria:
• • Previous treatment (within the last 28 days) with vigabatrin or corticosteroid
• • Previous diagnosis of epileptic encephalopathy e.g. early infantile epileptic encephalopathy and early myoclonic epileptic encephalopathy
• • Has a clinical suspicious or diagnosis of tuberous sclerosis complex characterized by one of these; known affected parent, previously diagnosed cardiac rhabdomyoma, hypomelanotic macules, forehead fibrous plaque, shagreen patch, retinal phakoma, or known polycystic kidneys
• • A contraindication to vigabatrin or corticosteroid such as recent varicella or herpes zoster infection, gastrointestinal hemorrhage etc.
• • Thai language ability of the parents or guardians is that they may not understand what is being requested of them.
• • Predictable lack of availability of follow up