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:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
NCT ID:
NCT04210206
Eligibility Criteria:
Inclusion Criteria:
* Men and women with classical PKU
* Age ≥ 18 years
* Good metabolic control during childhood (at least until 12 years of age)
* Plasma Phe levels ≥ 15 mg/dl for ≥ 1 year
* Written informed consent prior to study participation
Exclusion Criteria:
* Reduced cognitive function (unability to perform test battery)
* Drug and or alcohol abuse
* Treatment with BH4
* Treatment with drugs known to affect cognitive function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT04210206
Study Brief:
Protocol Section:
NCT04210206