A Study to Prevent Infantile Spasms Relapse

Description

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

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Study Overview

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Study Details

Study 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.

A Multicenter Pilot Clinical Trial to Prevent Infantile Spasms Relapse

A Study to Prevent Infantile Spasms Relapse

Condition
Infantile Spasms
Intervention / Treatment

-

Contacts and Locations

Los Angeles

UCLA, Los Angeles, California, United States, 90095

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • 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 3 months of screening, or any change in stimulation parameters within 1 month of screening
  • 5. Treatment of IESS via epilepsy surgery

Ages Eligible for Study

2 Months to 18 Months

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, Los Angeles,

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

Study Record Dates

2028-06-30