Clinical Trial on 7-day Followed by Maintenance Therapy for 10 Weeks vs. 14-day and no Maintenance Course of Prednisolone for the Treatment of Infantile Epileptic Spasms Syndrome (IESS)

The goal of this clinical trial is to learn if short courses (7 days) of oral prednisolone are as effective as longer courses (14 days) in treating Infantile Epileptic Spasms Syndrome (IESS) in infants. The main questions it aims to answer are: 1. Does a 7-day course of oral prednisolone result in a similar or better reduction in spasm frequency compared to a 14-day course? 2. Does the duration of treatment (7 vs. 14 days) influence relapse rates and developmental outcomes in infants with IESS? 3. Researchers will compare the effects of the two treatment arms (7-day course vs. 14-day course of oral prednisolone) to see if there is a difference in efficacy and safety. Participants will: 1. Receive either a 7-day or 14-day course of oral prednisolone as part of their treatment 2. Be monitored for spasm frequency and any side effects during hospital observation for the first 48 hours 3. Maintain a spasm diary during the treatment period to track spasm frequency 4. Return for follow-up visits at 7 days, 14 days, 28 days, 42 days, 3 months, 6 months, and 12 months to assess treatment response, relapse, and developmental outcomes

NCT Number	NCT06838559
Lead Sponsor	University of Colombo
Conditions	Spasms, Infantile, Prednisolone
Enrollment	182 participants
Start Date	2025-01-01
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-02-24