Combining vigabatrin and high dose prednisolone for treating infantile spasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of a combination therapy of vigabatrin and high dose prednisolone against vigabatrin alone in treating infantile spasms, a severe form of epilepsy in infants. The trial will enroll Thai infants aged 2 to 14 months who have been clinically diagnosed with infantile spasms. The study will assess both the cessation of spasms and the electrographic response to treatment, which are critical for optimal neurodevelopmental outcomes. Given the challenges of ACTH availability and cost in developing countries, this research seeks to provide a viable alternative treatment option.

Why it matters

Who can join: the full rules

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

Where it's running

• Queen Sirikit National Institute of Child Health
  Ratchathewi, Bangkok, Thailand Recruiting

Study contacts

• Principal investigator: Kullasate Sakpichaisakul, MD — Queen Sirikit National Institute of Child Health
• Study coordinator: Kullasate Sakpichaisakul, MD
• Email: kullasate.s@rsu.ac.th
• Phone: 66-2-354-8333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.