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
This trial does not accept healthy volunteersQualifiers
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
Design model
Factorial
Treatments tested in this trial
Prednisolone
Drugactive drug
Famotidine
Drugactive drug
Placebo
Drugnon-active drug
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Low-dose prednisoloneActive comparator 2 interventions
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of treatment-emergent adverse events
The investigators will tabulate of adverse events and determine whether any adverse event is associated with prednisolone treatment during the first 5 months of the study.
Time frame
From enrollment to 5-month visit.2
Incidence of epileptic spasms relapse
The investigators will record whether or not study participant experience a relapse of epileptic spasms during the study. Relapse is classified as present or absent and based on interpretation of EEG.
Time frame
From enrollment to last evaluation at age 2 yearsSecondary outcomes
1
Incidence of autism spectrum disorder
At the final study visit, the investigators will use DSM-V criteria to determine if study participants fulfill diagnostic criteria for autism spectrum disorder.
Time frame
From enrollment to last evaluation at age 2 years2
Developmental/Behavioral Level
At the final study visit at age 2 years, the investigators will measure adaptive behavior using the Vineland-3 questionnaire.
Time frame
From enrollment to last evaluation at age 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
Pediatric Epilepsy Research Foundation
Collaborator
Source ClinicalTrials.gov