A Study to Prevent Infantile Spasms Relapse
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-18
SponsorUniversity of California, Los Angeles
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Exposure to any artisanal cannabinoid product within 14 days of screening
Ongoing therapy with the ketogenic diet
Implantation of a vagal nerve stimulator within 3 months of screening, or any change in stimulation parameters within 1 month of screening
Trial design
Treatments tested in this trial
- Prednisolone
- Famotidine
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of California, Los Angeles
Lead sponsor
Pediatric Epilepsy Research Foundation
Collaborator
Source ClinicalTrials.gov