NCT06838559

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)

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)

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: University of Colombo · Academic / Other
• Sex: All
• Age: 3 Months – 24 Months
• Healthy volunteers: Not accepted

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

Detailed description

Study Title: Comparison of Short (7-Day) versus Long (14-Day) Courses of Oral Prednisolone in the Treatment of Infantile Epileptic Spasms Syndrome (IESS) Study Overview: This is a clinical trial designed to compare the efficacy and safety of two treatment regimens using oral prednisolone for infants with Infantile Epileptic Spasms Syndrome (IESS). The study aims to evaluate the impact of treatment duration (7 days vs. 14 days) on spasm resolution, relapse rates, and developmental outcomes in infants with IESS. Participants will be randomized into two treatment arms to receive either a 7-day or 14-day course of oral prednisolone, and they will be followed for a year to assess outcomes related to spasm control, relapse, adverse effects, and long-term development. Study Population: The study will include infants diagnosed with IESS, aged 3 to 24 months, who are receiving care at participating clinical sites. Eligibility criteria ensure the inclusion of infants with confirmed spasms, with or without known aetiology, and those who have not previously received systemic treatment for IESS. Objectives: * Primary Objective: To compare the effectiveness of 7-day versus 14-day oral prednisolone treatment in reducing spasm frequency in infants with IESS. * Secondary Objectives: To evaluate the impact of treatment duration on relapse rates, developmental outcomes, and adverse effects. * Exploratory Objectives: To assess any differences in long-term neurodevelopmental progress, including cognitive and motor development, and to compare EEG findings between treatment groups. Methodology: 1. Randomization: Participants will be randomly assigned to receive either 7 days or 14 days of oral prednisolone, with blinding for the treatment duration. 2. Treatment Regimen: * Intervention Arm (7-Day Course): Participants will receive 3 mg/kg/day of oral prednisolone for 7 days. * Comparator Arm (14-Day Course): Participants will receive 3 mg/kg/day of oral prednisolone for 14 days. * In both arms, after 48 hours of in-hospital treatment, participants will be monitored for side effects, and parents will be educated on medication administration and spasm monitoring. 3. Adverse Event Monitoring: Adverse events will be tracked throughout the trial, with particular attention to common side effects associated with prednisolone use, including irritability, weight gain, and gastric irritation. Serious adverse events will be carefully documented and managed. 4. Follow-Up: Follow-up visits will be conducted at 7 days, 14 days, 28 days, 42 days, 3 months, 6 months, and 12 months to monitor spasm control, relapse, and developmental progress. At 24 months, a comprehensive developmental assessment will be conducted to evaluate the long-term effects of the treatment. Inclusion and Exclusion Criteria: * Inclusion Criteria: Infants diagnosed with IESS, aged 2 to 24 months, with confirmed spasms either due to a known or unknown aetiology. * Exclusion Criteria: Infants with a history of other significant neurological conditions, or who are contraindicated for oral prednisolone, including those with uncontrolled systemic infections, significant cardiovascular disease, or severe hypertension. Data Collection: Baseline Data: Clinical history, imaging (CT or MRI), and EEG results will be collected to help categorize participants into known or undetermined aetiology groups. A metabolic screening will be conducted for infants with undetermined aetiology.

Conditions

• Spasms, Infantile
• Prednisolone

Interventions

Type	Name	Description
DRUG	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).
DRUG	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-02-20
• Last updated: 2025-02-24

Locations

7 sites across 1 country: Sri Lanka