NCT06838559Active, not recruitingPhase 4
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)
Source: ClinicalTrials.gov · Last updated 24 Feb 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- First submitted
- 17 Feb 2025
- Start date
- 1 Jan 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- University of Colombo
- Diseases
- Epilepsy
- NCT number
- NCT06838559
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 182
- From 1 Jan 2025 to the primary completion date, 31 Dec 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ever treated previously for infantile epileptic spasms syndrome with steroids or other anticonvulsants
Other illness
- Infants already on steroids or ACTH for any other illness
- Contraindication for the use of high dose steroids such as underlying infection, immune deficiency, hypertension etc.
- Children in critical conditions such as severe infections, congenital heart disease or requiring ventilation or care in an ICU
Other
- Infants with tuberous sclerosis complex
- Not accompanied by parent/s or parent's inability to complete follow up
Who the study is looking for
- Infants between ages of 3 to 24 months
- Newly confirmed diagnosis of infantile epileptic spasms syndrome made by the referring paediatrician/ paediatric neurologist based on the diagnostic criteria outlined in the recent ILAE classification and definition of epilepsy syndrome with onset in neonates and infants in 2022
- Hypsarrhythmia recorded on pre-treatment EEG. This will be those who show a BASED score of 4 or 5 in a standard EEG
Age in the registry: 3 months to 24 months · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Teaching Hospital Anuradhapura Coordinator of this site? Confirm its status | Anuradhapura | Sri Lanka | Unknown status |
| Lady Ridgeway Hospital for Children Coordinator of this site? Confirm its status | Colombo | Sri Lanka | Unknown status |
| Teaching Hospital - Karapitiya Coordinator of this site? Confirm its status | Galle | Sri Lanka | Unknown status |
| Teaching Hospital - Jaffna Coordinator of this site? Confirm its status | Jaffna | Sri Lanka | Unknown status |
| Colombo South Teaching Hospital Coordinator of this site? Confirm its status | Kalubowila | Sri Lanka | Unknown status |
| Sirimavo Bandaranayake Specialized Children's Hospital Coordinator of this site? Confirm its status | Peradeniya | Sri Lanka | Unknown status |
| Colombo North Teaching Hospital Coordinator of this site? Confirm its status | Ragama | Sri Lanka | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.