RecruitingPhase 2

A Study to Prevent Infantile Spasms Relapse

United States40 participantsStarted 2025-05-05

Plain-language 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

Age range2 Months – 18 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Incidence of treatment-emergent adverse events

Timeframe: From enrollment to 5-month visit.

Incidence of epileptic spasms relapse

Timeframe: From enrollment to last evaluation at age 2 years

Trial details

NCT IDNCT06819670

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-02-28

Contact for this trial

Shaun A. Hussain, MD, MS

310-206-7630 shussain@mednet.ucla.edu

View on ClinicalTrials.gov More Infantile Spasms trials