A Study to Prevent Infantile Spasms Relapse

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Infantile Spasms, Infantile Epileptic Spasms Syndrome, West Syndrome

In brief

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.

Key facts

Study ID

NCT06819670

Run by

University of California, Los Angeles

People needed

40

Starts

2025-05-05

Expected to finish

2028-06-30

Last updated by the study team

2025-05-08

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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
• Exposure to any artisanal cannabinoid product within 14 days of screening
• Ongoing therapy with the ketogenic diet
• Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
• Treatment of IESS via epilepsy surgery

Where it is running

• UCLA — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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