A Study to Prevent Infantile Spasms Relapse
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of California, Los Angeles
- Study ID
- NCT06819670
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Infantile Epileptic Spasms Syndrome
- Infantile Spasms
- West Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Months - 18 Months
- Healthy Volunteers
- Not accepted
Interventions
- Prednisolone — DRUGactive drug
- Famotidine — DRUGactive drug
- Placebo — DRUGnon-active drug
Study Details
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.
Key Dates
- Start date
- May 5, 2025
- Status verified
- May 2025
- Primary completion
- Feb 28, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- PREVENTION
Arms
- Active Comparator: Low-dose prednisolonePrednisolone and famotidine.
- Placebo Comparator: PlaceboPlacebo (prednisolone) and placebo (famotidine)
Primary Outcome Measure
Incidence of treatment-emergent adverse events [ Time Frame: From enrollment to 5-month visit. ]
Central Contacts
- Shaun A. Hussain, MD, MS310-206-7630
- Angela L. Martinez310-206-7630
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCLA | Los Angeles | California | 90095 | Shaun Hussain, MD, MS (PRINCIPAL_INVESTIGATOR) |
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