NCT06819670

A Study to Prevent Infantile Spasms Relapse

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 2 Months – 18 Months
• Healthy volunteers: Not accepted

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.

Detailed description

In this study, the investigators will enroll infants who have responded to standard therapy for treatment of Infantile Epileptic Spasms Syndrome (IESS). Patients will be randomized to receive either low-dose prednsiolone or placebo for 4 months. During the first 7 months, patients will be evaluated monthly, with clinic visits and electroencephalography (EEG). Patients will then return for a final visit at age 2 years. Key outcomes will be determination of IESS relapse, emergence of other types of seizures/epilepsy, and evaluation of developmental/behavioral status at age 2 years. We will attempt to determine whether or not the prednisolone intervention reduces the risk of any adverse outcome, but this may not be possible given the study design. We will also evaluate the feasibility of the intervention, study procedures, and recruitment.

Conditions

• Infantile Spasms
• Infantile Epileptic Spasms Syndrome
• West Syndrome

Interventions

Type	Name	Description
DRUG	Prednisolone	active drug
DRUG	Famotidine	active drug
DRUG	Placebo	non-active drug

Timeline

• Start date: 2025-05-05
• Primary completion: 2028-02-28
• Completion: 2028-06-30
• First posted: 2025-02-11
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study