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A Study to Prevent Infantile Spasms Relapse

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

Who can join

2 Months – 18 Months · All sexes

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

About the study

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.

What is being tested

• Prednisolone (drug)
• Famotidine (drug)
• Placebo (drug)

Sponsor: University of California, Los Angeles · Participants: 40 · Started: May 5, 2025

Contact the study team

• Shaun A. Hussain, MD, MS · Phone: 310-206-7630
• Angela L. Martinez · Phone: 310-206-7630

Official record on ClinicalTrials.gov — NCT06819670

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.