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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT05174559
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 18 years
* diagnosis of classical PKU (blood phenylalanine ≥1200 µmol pre-treatment or off-treatment
* ≥ 2 PKU-related symptoms with clinically meaningful negative impact on daily life
* is in regular clinical monitoring and is treated with a PKU diet with a natural protein restriction and medical foods
* average blood phenylalanine levels between 360 and 900 µmol in past one year
* able and willing to provide consent
* demonstrates capacity to complete all requirements of the protocol
* if on medications approved by the Principal Investigator agrees not to alter dose for duration of study
* has stable daily access to phone, internet, and physical address
Exclusion Criteria:
* women who are breastfeeding, pregnant or planning to become pregnant in the next year
* use of adjuvant PKU treatments (LNAAs, Kuvan®, Palinziq®) within past 3 months
* use of psychotropic medications, melatonin, or any serotonin-reuptake inhibitors within past 3 months
* demonstrates insufficient motivation or time required to complete full trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05174559
Study Brief:
Protocol Section:
NCT05174559