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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)
Sponsor: University of Colombo
Summary
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
Official title: Multicentre, Randomized, Controlled 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)
Key Details
Gender
All
Age Range
3 Months - 24 Months
Study Type
INTERVENTIONAL
Enrollment
182
Start Date
2025-01-01
Completion Date
2027-12-31
Last Updated
2025-02-24
Healthy Volunteers
No
Conditions
Interventions
Short-Duration Oral Prednisolone with Extended Tapering
In treatment arm A, oral prednisolone will be administered in tablet form (5 mg strength) as follows: an initial phase of 10 mg four times daily (total 40 mg/day) for 7 days, followed by a 15-day tapering phase-10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. After tapering, a prolonged low-dose maintenance phase will be implemented, where 10 mg is given once daily twice a week for an additional 10 weeks. This regimen is designed to test whether a shorter high-dose course, combined with extended low-dose maintenance, can provide equivalent control of infantile epileptic spasms syndrome while reducing the adverse effects associated with longer high-dose therapy, compared to the standard 14-day high-dose regimen (treatment arm B).
Standard Oral Prednisolone Regimen with Tapering
Prednisone oral tablets, 10 mg, administered four times daily (40 mg/day) for 14 days, followed by a tapering phase over 15 days: 10 mg three times daily for 5 days, 10 mg twice daily for 5 days, and 10 mg once daily for 5 days. No further tapering will be implemented after the initial 14-day treatment period. This regimen represents the standard therapy for Infantile Spasms in Sri Lanka.
Locations (7)
Sirimavo Bandaranayake Specialized Children's Hospital
Peradeniya, Central Province, Sri Lanka
Teaching Hospital Anuradhapura
Anuradhapura, North Central Province, Sri Lanka
Teaching Hospital - Jaffna
Jaffna, Northern Province, Sri Lanka
Teaching Hospital - Karapitiya
Galle, Southern Province, Sri Lanka
Lady Ridgeway Hospital for Children
Colombo, Western Province, Sri Lanka
Colombo South Teaching Hospital
Kalubowila, Western Province, Sri Lanka
Colombo North Teaching Hospital
Ragama, Western Province, Sri Lanka