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Compares treatment options for Infantile Spasm
Official title Vigabatrin With High Dose Prednisolone Combination Therapy vs Vigabatrin Alone for Infantile Spasm
ClinicalTrials.gov ID: NCT04302116
What this study is testing
What is Combination therapy with vigabatrin and prednisolone?
Combination therapy with vigabatrin and prednisolone is an investigational medicine, given as an once-daily, being studied as a potential treatment for infantile spasm.
Also referred to as Sabril with prednisolone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 14
You may be able to join 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 likely can't join 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Ratchathewi, Bangkok, Thailand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 months to 14 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ratchathewi, Bangkok, Thailand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.