The Psychosocial Functioning of Adults With Phenylketonuria. (CoMet-PCU)

February 5, 2026 updated by: Central Hospital, Nancy, France
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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study will be offered to all adult subjects and their close relatives who know the person well as part of the follow-up for PKU at the Centre de Référence des maladies héréditaires du métabolisme at the Nancy CHRU.

This study will be offered to a second metabolic reference center.

Description

Inclusion Criteria:

Patients :

  • Age ≥ 18 years and < 59 years (age limit for ASEBA questionnaire)
  • Person being monitored for PKU / HMP
  • Relative living with the person
  • Person who has received full information on the organization of the research and has not objected to the use of this data
  • Compulsory membership of a social security scheme

Relatives:

  • Age ≥ 18 years
  • Person who has received full information on the organization of the research and has not objected to the use of this data
  • Compulsory membership of a social security scheme

Exclusion Criteria:

  • Refusal or linguistic, physical or psychological incapacity to to participate in the study
  • Subjects under court protection
  • Subjects under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient
Relative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score ASEBA
Time Frame: single time point upon the study enrollment
Total score ASEBA
single time point upon the study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

June 15, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PI020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Phenylketonuria (PKU)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe