A Study to Prevent Infantile Spasms Relapse
Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Feb 4, 2025
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking to find out if a low dose of a medication called prednisolone can help prevent relapses in children who have previously been treated successfully for infantile spasms. Infantile spasms are a type of seizure that can affect very young children and, unfortunately, some of these children may experience a return of their symptoms after treatment. This study aims to see if using prednisolone can safely reduce the chances of these relapses, which can lead to more serious long-term issues like autism or other types of epilepsy.
To be eligible for this study, children must be between 2 to 18 months old and diagnosed with infantile spasms syndrome. They should have shown a complete response to standard treatments like prednisolone, ACTH, or vigabatrin, confirmed by an EEG test. Unfortunately, some children won't be able to participate due to other health issues or recent treatments. If eligible, participants will be monitored closely to see how well they tolerate the medication and if it helps to keep their symptoms from coming back. This study is not yet recruiting participants, but it represents an important step towards better care for children with this condition.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age 2 to 18 months, inclusive
- • 2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin)
- Exclusion Criteria:
- • 1. 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
- • 2. Exposure to any artisanal cannabinoid product within 14 days of screening
- • 3. Ongoing therapy with the ketogenic diet
- • 4. Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
- • 5. Treatment of IESS via epilepsy surgery
About University Of California, Los Angeles
The University of California, Los Angeles (UCLA) is a prestigious academic institution renowned for its commitment to research and innovation in the biomedical field. As a clinical trial sponsor, UCLA leverages its cutting-edge facilities, expert faculty, and collaborative environment to advance medical knowledge and improve patient care. The university is dedicated to conducting rigorous clinical research that adheres to the highest ethical standards, aiming to translate scientific discoveries into effective therapies and interventions. Through its diverse array of clinical trials, UCLA seeks to address critical health challenges while fostering the development of future healthcare leaders.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Patients applied
Trial Officials
Shaun A. Hussain, MD, MS
Principal Investigator
University of California, Los Angeles
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported