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 @ 4:38 PM
Ignite Modification Date:
2025-12-24 @ 4:38 PM
NCT ID:
NCT01278966
Eligibility Criteria:
Inclusion Criteria:
* age: 2-18 years
* At least 3 epileptic seizures per week
* Tried at least two anti-epileptic drugs without satisfactory seizure control
* Willing to try diet treatment for 6 months
Exclusion Criteria:
* Too difficult for the family to adhere to a strict diet
* Not able to fill in a seizure calendar
* Local authorities will not approve the treatment
* VNS stimulator the last 12 months or changes made to VNS stimulator during the last three months
* Other disease where a diet high in fat is contra indicated
* Diet treatment is not possible because of poor intake of food or fluids
* Cortisol or other medication that influence energy metabolism or epileptic drug metabolism last month
* Patient has the last month used alternative medicine which may influence the diet
* Patient has tried the ketogenic fiet og Modified Atkins diet the last three years
* pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
18 Years
Study:
NCT01278966
Study Brief:
Protocol Section:
NCT01278966