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

Recruiting now · Not applicable

Conditions studied: Infantile Spasm, West Syndrome

In brief

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.

Key facts

Study ID

NCT04302116

Run by

Kullasate Sakpichaisakul

People needed

250

Starts

2020-05-18

Expected to finish

2026-12-01

Last updated by the study team

2021-08-25

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Queen Sirikit National Institute of Child Health — Ratchathewi, Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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