A Phase 2 interventional study of Prednisolone and Famotidine in Infantile Spasms, Infantile Epileptic Spasms Syndrome and West Syndrome, sponsored by University of California, Los Angeles. Recruiting at 1 site in United States. Open to participants aged 2 Months to 18 Months. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by University of California, Los Angeles · Phase 2, Interventional, and Prevention
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.
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.
47 studies on the registry are indexed under Spasms, Infantile; 8 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 33 interventional studies indexed under Spasms, Infantile.
Browse Spasms, Infantile studies →University of California, Los Angeles is the lead sponsor of 1,170 studies on the registry; 195 are open to participants now.
Of its 95 completed or terminated interventional studies of FDA-regulated products, 70 (74%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Prednisolone and famotidine.
Drug: Prednisolone · Drug: Famotidine
Placebo (prednisolone) and placebo (famotidine)
Drug: Placebo
active drug
active drug
non-active drug
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.
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 years
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 years
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 years
Plan to share: Yes — Deidentified study data will be shared with other researchers upon reasonable request, after publication of results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: IPD will be shared upon reasonable request after publication of study results.
Access criteria: Deidentified patient data, study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code.
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Studies of the drugs tested here: Prednisolone · Famotidine
University of California, Los Angeles →