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)

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

Conditions

• Spasms, Infantile
• Prednisolone

Interventions

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.

Sponsors & Collaborators

• University of Colombo

  lead OTHER

Principal Investigators

• Jithangi Wanigasinghe, MD, MPhil · Department of Paediatrics at the Faculty of Medicine, University of Colombo, Sri Lanka

• Carukshi Arambepola, MSc, MD · Department of Community Medicine, Faculty of Medicine, University of Colombo, Sri Lanka

• Shalini Sri Ranganathan, MD, PhD · Department of Pharmacology, Faculty of Medicine, University of Colombo, Sri Lanka

• Nimesha Gamhewage, MD, DCH · Department of Paediatrics, University of Sri Jayewardenepura, Sri Lanka

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Months

Max Age

24 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Sri Lanka

Study Locations