A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
University of California, Los Angeles
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.
Description
In this study, the investigators will enroll infants who have responded to standard therapy for treatment of Infantile Epileptic Spasms Syndrome (IESS). Patients will be randomized to receive either low-dose prednsiolone or placebo for 4 months. During the first 7 months, patients will be evaluated monthly, with clinic visits and electroencephalography (EEG). Patients will then return for a final visit at age 2 years. Key outcomes will be determination of IESS relapse, emergence of other types of seizures/epilepsy, and evaluation of developmental/behavioral status at age 2 years. We will attem…
Eligibility
- Age range
- 0–1 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPrednisolone
active drug
- DrugFamotidine
active drug
- DrugPlacebo
non-active drug
Location
- UCLALos Angeles, California