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) (SLISS)

NCT06838559 PHASE4 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	University of Colombo
Phase	PHASE4
Status	ACTIVE_NOT_RECRUITING
Enrolment	182
Start date	Wed Jan 01 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Dec 31 2027 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Spasms, Infantile
• Prednisolone

Interventions

• Short-Duration Oral Prednisolone with Extended Tapering
• Standard Oral Prednisolone Regimen with Tapering

Countries

Sri Lanka