A Study to Prevent Infantile Spasms Relapse
Recruiting
Phase 2
Interventional Study
Infantile Spasms
Infantile Epileptic Spasms Syndrome
West Syndrome
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 Months – 18 Months
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 40 (estimated)
- Sponsor
- University of California, Los Angeles · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 oth…
Contacts