RECRUITING

A Study to Prevent Infantile Spasms Relapse

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

Quick Facts

Study Start:2025-05-05
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06819670

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:2 Months to 18 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. Age 2 to 18 months, inclusive
  2. 2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed complete response to standard treatment (prednisolone, ACTH, and/or vigabatrin)
  1. 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. 2. Exposure to any artisanal cannabinoid product within 14 days of screening
  3. 3. Ongoing therapy with the ketogenic diet
  4. 4. Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
  5. 5. Treatment of IESS via epilepsy surgery

Contacts and Locations

Study Contact

Shaun A. Hussain, MD, MS
CONTACT
310-206-7630
shussain@mednet.ucla.edu
Angela L. Martinez
CONTACT
310-206-7630
angelamartinez@mednet.ucla.edu

Principal Investigator

Shaun A. Hussain, MD, MS
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Shaun A. Hussain, MD, MS, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-05-05
Study Completion Date2028-06-30

Terms related to this study

Keywords Provided by Researchers

  • Relapse
  • Infantile Spasms
  • Prednisolone

Additional Relevant MeSH Terms

  • Infantile Spasms
  • Infantile Epileptic Spasms Syndrome
  • West Syndrome