A Study 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 red
| Condition(s) | Infantile Spasms, Infantile Epileptic Spasms Syndrome, West Syndrome |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Age 2 to 18 months, inclusive 2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin) Exclusion Criteria: 1. 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 2. Exposure to any artisanal cannabinoid product within 14 days of screening 3. Ongoing therapy with the ketogenic diet 4. Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening 5. Treatment of IESS via epilepsy surgery |
| Ages | 2 Months to 18 Months |
| Sex | All |
| Lead sponsor | University of California, Los Angeles |
| Locations | Los Angeles, California, United States |
| Start date | 2025-05-05 |
| NCT ID | NCT06819670 |
| Official listing | https://clinicaltrials.gov/study/NCT06819670 |