Actively Recruiting
A Study to Prevent Infantile Spasms Relapse
Led by University of California, Los Angeles · Updated on 2025-05-08
40
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
U
University of California, Los Angeles
Lead Sponsor
P
Pediatric Epilepsy Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Prevent Infantile Spasms Relapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2 to 18 months, inclusive
- Clinical diagnosis of infantile spasms syndrome
- EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin)
You will not qualify if you...
- Clinically significant hypertension, infection, or any other diagnosis posing unreasonable risk for extended corticosteroid therapy
- Use of any artisanal cannabinoid product within 14 days of screening
- Current therapy with the ketogenic diet
- Vagal nerve stimulator implanted within 3 months or parameter changes within 1 month of screening
- Treatment of IESS with epilepsy surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
S
Shaun A. Hussain, MD, MS
CONTACT
A
Angela L. Martinez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
PREVENTION
Number of Arms
2
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