RecruitingPhase 2NCT06819670

A Study to Prevent Infantile Spasms Relapse

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

Sponsor

University of California, Los Angeles

Enrollment

40 participants

Start Date

May 5, 2025

Study Type

INTERVENTIONAL

Conditions

West Syndrome Infantile Spasms Infantile Epileptic Spasms Syndrome

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.

Eligibility

Min Age: 2 MonthsMax Age: 18 Months

Inclusion Criteria2

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 Criteria5

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

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