Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT06838559
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* Infants with tuberous sclerosis complex
* Ever treated previously for infantile epileptic spasms syndrome with steroids or other anticonvulsants
* 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
* Not accompanied by parent/s or parent's inability to complete follow up
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
24 Months
Study:
NCT06838559
Study Brief:
Protocol Section:
NCT06838559