A Study to Prevent Infantile Spasms Relapse
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Prednisolone, Famotidine, Placebo.
- Who it may be relevant to
- Registry conditions: Infantile Spasms, Infantile Epileptic Spasms Syndrome, West Syndrome. Basic parameters: 2 months — 18 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse
Overview
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.
Detailed 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 attempt to determine whether or not the prednisolone intervention reduces the risk of any adverse outcome, but this may not be possible given the study design. We will also evaluate the feasibility of the intervention, study procedures, and recruitment.
Interventions
- Drug Prednisolone
active drug - Drug Famotidine
active drug - Drug Placebo
non-active drug
Primary outcome measures
- Incidence of treatment-emergent adverse events [Time frame: From enrollment to 5-month visit.]
- Incidence of epileptic spasms relapse [Time frame: From enrollment to last evaluation at age 2 years]
Secondary outcome measures (2)
- Incidence of autism spectrum disorder [Time frame: From enrollment to last evaluation at age 2 years]
- Developmental/Behavioral Level [Time frame: From enrollment to last evaluation at age 2 years]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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
- Treatment of IESS via epilepsy surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- UCLA — Los Angeles
Publications
- Hussain SA. Treatment of infantile spasms. Epilepsia Open. 2018 Oct 23;3(Suppl Suppl 2):143-154. doi: 10.1002/epi4.12264. eCollection 2018 Dec. PMID 30564773
Identifiers
NCT: NCT06819670 · 22-001710 · 20224426