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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT03764956
Eligibility Criteria:
Inclusion Criteria:
* Children aged 1-15 years with drug resistant epilepsy
* Willing to come for regular follow-up according to study protocol Drug resistant epilepsy defined as
* Seizure frequency \>4 seizures per month, while on optimal doses of at least 2 prescribed antiepileptic drugs
* For West syndrome, drug resistant epilepsy will be defined as more than 4 clusters of spasms per month despite treatment with antiepileptic drugs and either ACTH(Adrenocorticotrophic hormone) or Vigabatrin
Exclusion Criteria:
* Surgically remediable causes for DRE
* Inborn errors of metabolism
* Previously received KD, MAD or LGIT
* Known case of
1. Chronic kidney disease
2. Chronic liver disease/GI illness
3. Congenital/acquired heart disease
4. Chronic respiratory illness
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
15 Years
Study:
NCT03764956
Study Brief:
Protocol Section:
NCT03764956