Plain-English translation of NCT06819670 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing whether , a low-dose steroid medication, can help prevent infantile spasms from coming back in babies whose seizures have already stopped with standard treatment. Infants who have successfully responded to initial therapy will receive either the medication or a placebo for 4 months, and doctors will monitor them closely over the next 2 years to see if the treatment reduces the chance of seizures returning.
Once infantile spasms are controlled with standard treatment, they can sometimes return—and this relapse can affect a child's development. Researchers want to know whether using this medication for a few months after successful treatment can prevent seizures from coming back and protect the baby's long-term development.
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Your baby will be randomly assigned to receive either the low-dose medication or a placebo for 4 months. During the first 7 months, you'll visit the clinic monthly for check-ups and EEG tests to monitor your baby's brain activity. After that, you'll return for one final visit when your baby reaches 2 years old. Doctors will track whether seizures return, watch for any new seizure types, and assess your child's development and behavior over time.
AI-generated summary from trial data · Jun 10, 2026 · Not medical advice
United States
Phase
Testing effectiveness
Sponsor
University of California, Los Angeles
Collaborators
Pediatric Epilepsy Research Foundation
Enrollment target
~40 participants
Started
May 2025
Primary completion
February 2028
Age range
2 Months – 18 Months
Last updated on clinicaltrials.gov in May 2025.
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Central contact
Shaun A. Hussain, MD, MS
University of California, Los Angeles
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