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A Study to Prevent Infantile Spasms Relapse

NCT06819670 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-05-08

No results posted yet for this 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.

Conditions

  • Infantile Spasms
  • Infantile Epileptic Spasms Syndrome
  • West Syndrome

Interventions

DRUG

Prednisolone

active drug

DRUG

Famotidine

active drug

DRUG

Placebo

non-active drug

Sponsors & Collaborators

Principal Investigators

  • Shaun A. Hussain, MD, MS · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
2 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-05
Primary Completion
2028-02-28
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06819670 on ClinicalTrials.gov