Plain-English translation of NCT04302116 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.
This trial is testing whether babies with infantile spasms (a serious type of seizure disorder) do better when treated with vigabatrin combined with a steroid called prednisolone, compared to vigabatrin alone. Infantile spasms are a form of epilepsy that can affect a baby's development, and doctors want to find the most effective way to stop these seizures quickly. This study will help answer whether using two medications together is more powerful than using one.
Infantile spasms are a medical emergency that need quick treatment to prevent lasting harm to a baby's brain and development. While this medication is known to work, doctors are not yet sure whether combining it with a steroid gives babies a better chance of stopping the seizures completely compared to using the medication alone.
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If your baby is enrolled, you will be randomly assigned to give either the medication alone or the medication combined with a steroid. Both treatments start immediately and involve giving tablets by mouth — the doses are carefully calculated based on your baby's weight and may be adjusted if seizures continue. The treatment period lasts about one month, with the medications then gradually stopped over the following weeks. You will need to bring your baby to clinic visits for monitoring, and your baby will have EEG tests to measure brain activity and check if the seizures have stopped.
AI-generated summary from trial data · Jun 19, 2026 · Not medical advice
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