A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 1
Healthy Volunteers: f
View:
• 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)
Locations
United States
California
UCLA
RECRUITING
Los Angeles
Contact Information
Primary
Shaun A. Hussain, MD, MS
shussain@mednet.ucla.edu
310-206-7630
Backup
Angela L. Martinez
angelamartinez@mednet.ucla.edu
310-206-7630
Time Frame
Start Date: 2025-05-05
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 40
Treatments
Active_comparator: Low-dose prednisolone
Prednisolone and famotidine.
Placebo_comparator: Placebo
Placebo (prednisolone) and placebo (famotidine)
Related Therapeutic Areas
Sponsors
Leads: University of California, Los Angeles
Collaborators: Pediatric Epilepsy Research Foundation