A Study to Prevent Infantile Spasms Relapse

Last updated: May 5, 2025
Sponsor: University of California, Los Angeles
Overall Status: Active - Recruiting

Phase

2

Condition

Infantile Spasms

Seizure Disorders (Pediatric)

Pain (Pediatric)

Treatment

Famotidine

Prednisolone

Placebo

Clinical Study ID

NCT06819670
22-001710
20224426
  • Ages 2-18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 2 to 18 months, inclusive

  2. Clinical diagnosis of infantile spasms syndrome, with EEG-confirmed completeresponse to standard treatment (prednisolone, ACTH, and/or vigabatrin)

Exclusion

Exclusion Criteria:

  1. Presence of clinically significant hypertension, infection, or any other diagnosiswhich poses unreasonable risk in the setting of extended corticosteroid therapy, inthe 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 3 months of screening, or any changein stimulation parameters within 1 month of screening

  5. Treatment of IESS via epilepsy surgery

Study Design

Total Participants: 40
Treatment Group(s): 3
Primary Treatment: Famotidine
Phase: 2
Study Start date:
May 05, 2025
Estimated Completion Date:
June 30, 2028

Study 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.

Connect with a study center

  • UCLA

    Los Angeles, California 90095
    United States

    Active - Recruiting

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