Phenylketonuria (PKU)CoMet-PCUNCT07406009
The Psychosocial Functioning of Adults With Phenylketonuria.
An observational study of Phenylketonuria (PKU), run by Central Hospital, Nancy, France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Phenylketonuria (PKU)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2026to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Refusal or linguistic, physical or psychological incapacity to to participate in the study
- Subjects under court protection
- Subjects under guardianship or curatorship
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Phenylketonuria (PKU)
- Medical subject headings
- Phenylketonurias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Not described | |
| Relative | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total score ASEBA
Total score ASEBA
Measured: single time point upon the study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start15 Jan 2026 (estimated)
- Primary completion15 Mar 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phenylketonuria (PKU)Studies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406009
- Sponsor's protocol ID
- 2025PI020
- Acronym
- CoMet-PCU
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychosocial Functioning of Adults With Phenylketonuria.
- ClinicalTrials.gov ID
- NCT07406009
- Acronym / sponsor ID
- CoMet-PCU / 2025PI020
- Conditions
- Phenylketonuria (PKU)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Mar 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | – |
| Relative | – | – |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- Refusal or linguistic, physical or psychological incapacity to to participate in the study
- Subjects under court protection
- Subjects under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total score ASEBA
Time frame: single time point upon the study enrollment
Total score ASEBA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Phenylketonuria (PKU), run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eva Feigerlova, MD, PhD, MMEd (+330383154796, e.feigerlova@chru-nancy.Fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total score ASEBA (time frame: single time point upon the study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.