Tests low-dose prednisolone to prevent infantile spasms from returning
Tests low-dose prednisolone in infants whose spasms were initially controlled, to lower relapse risk.
Plain-language title generated from the registry record
Registry title: A Study to Prevent Infantile Spasms Relapse
Key facts
- Where
- Los Angeles, United StatesSee the site
- Phase
- Phase 2
Where in United States
- UCLALos Angeles, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of California, Los Angeles
- Trial code
- NCT06819670
- Record updated
- 8 May 2025
- Original description
After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.Read full original descriptionShow less
A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
After initially successful treatment, many children with infantile spasms unfortunately have a relapse, and relapse is linked to poor long-term outcomes such as autism and other forms of epilepsy. The aim of this study is to determine if treatment with low-dose prednisolone is safe, well tolerated, and effective in reducing the risk of relapse.
Inclusion: Age 2 to 18 months, inclusive; Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin).
Exclusion: Ongoing therapy with the ketogenic diet; Presence of clinically significant hypertension, infection, or any other diagnosis which poses unreasonable risk in the setting of extended corticosteroid therapy, in the view of the study physician; Treatment of IESS via epilepsy surgery; Exposure to any artisanal cannabinoid product within 14 days of screening; Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening.