Who may be eligible for the The Psychosocial Functioning of Adults With Phenylketonuria. trial?

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

ClinicalTrials.gov record NCT07406009

The Psychosocial Functioning of Adults With Phenylketonuria.

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

The Psychosocial Functioning of Adults With Phenylketonuria.

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old to 59 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This prospective, family-based observational study measures psychosocial functioning in adults with phenylketonuria (PKU) and a close relative using the ASEBA questionnaire at enrollment. It collects ASEBA total scores at a single time point to describe cognitive, emotional and psychosocial status in adults with PKU. The study is offered to adult patients followed at metabolic reference centers together with a relative who knows them well.

What it is studying. The study is testing how adults with PKU score on a standardized psychosocial questionnaire (ASEBA) and how psychosocial, cognitive and emotional measures vary between individuals when reported by the patient and a close relative.

What the researchers hope to learn. To describe psychosocial functioning of adults with PKU using ASEBA scores and to provide data that may inform understanding of variability in adult outcomes related to phenylalanine levels and individual responsiveness.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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 description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Both the person with PKU and their participating relative will complete questionnaires about psychosocial functioning, including the ASEBA, at a single time point on enrollment. The study will use information from the participant's PKU follow-up if they have not objected to its use. The registry record does not list any invasive procedures and gives no further details about additional tests or visits.

How the study is structured. A prospective, family-based observational study: adult PKU patients and a close relative complete the ASEBA psychosocial questionnaire; ASEBA total score is collected once at enrollment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on phenylketonuria

Clinical trials38 trials listed for phenylketonuriaEvery trial the registry lists for phenylketonuria, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in phenylketonuria researchLatest monthly update: September 2026. Includes: Diet supply gaps. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Jan 15, 2026 (estimated)
Primary completion: Mar 15, 2027 (estimated)
Study completion: Jun 15, 2027 (estimated)
Target enrollment: 30 participants (estimated)
Last updated on registry: Feb 12, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Central Hospital, Nancy, France

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Eva Feigerlova, MD, PhD, MMEd 📞 +330383154796 ✉ e.feigerlova@chru-nancy.Fr
François Feillet, MD, PhD 📞 +330383154796 ext. +330383154796 ✉ f.feillet@chru-nancy.fr

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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