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:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT00348933
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of AS
* In stable condition with relatively good control of seizures
* Willing to comply with treatment, study visit schedule, and study assessments
* Willing to take oral or G-tube medication
* Willing to be contacted monthly during the course of the study
* Parent or guardian willing to provide informed consent
Exclusion Criteria:
* History of liver or kidney disease
* Currently being treated for a serious acute illness
* Known hypersensitivity to any of the study drugs
* Received high-dose folate drug treatment in the 12 months prior to study entry
* Other significant medical problems, including those involving the liver, kidney, or heart
* Other comorbidities, genetic disorders, or extreme prematurity; children with autism are not excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Maximum Age:
5 Years
Study:
NCT00348933
Study Brief:
Protocol Section:
NCT00348933