Clinical Trials Directory

Trials / Not Yet Recruiting

Not Yet RecruitingNCT07406009

The Psychosocial Functioning of Adults With Phenylketonuria.

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years – 59 Years
Healthy volunteers
Accepted

Summary

Current recommendations are to maintain Phe levels \< 360 µmol/L throughout life (US consensus) or \< 600 µmol/L from the age of 12 (European consensus). Nevertheless, these recommendations do not take into account the individuality of each PKU patient who, in reality, reacts differently to Phe levels, with some patients with high levels (\> 1200 µmol/L) escaping the neurological consequences of high Phe levels without this being well understood (OJRD 2018; 13: 149. Can untreated PKU patients escape from intellectual disability? A systematic review). It is therefore unclear what blood levels of phenylalanine are required during adolescence and adulthood to maintain an optimal cognitive, emotional and neurophysiological state in individual PKU patients, depending on their personal responsiveness to Phe.

Conditions

Timeline

Start date
2026-01-15
Primary completion
2027-03-15
Completion
2027-06-15
First posted
2026-02-12
Last updated
2026-02-12

Source: ClinicalTrials.gov record NCT07406009. Inclusion in this directory is not an endorsement.