Preventing relapses in infants with spasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety and effectiveness of low-dose prednisolone in preventing relapse in infants diagnosed with Infantile Epileptic Spasms Syndrome (IESS) who have initially responded to standard treatments. Infants aged 2 to 18 months will be randomly assigned to receive either prednisolone or a placebo for four months, with monthly evaluations including clinic visits and EEG monitoring. The study will assess relapse rates, the emergence of other seizure types, and developmental outcomes at age two. The goal is to determine if prednisolone can reduce the risk of adverse outcomes associated with relapse.

Why it matters

Who can join: the full rules

Inclusion 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)

Exclusion Criteria:

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

Where it's running

• UCLA
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Shaun A. Hussain, MD, MS — University of California, Los Angeles
• Study coordinator: Shaun A. Hussain, MD, MS
• Email: shussain@mednet.ucla.edu
• Phone: 310-206-7630

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.