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

C

Central Hospital, Nancy, France

Status

Not yet enrolling

Conditions

Phenylketonuria (PKU)

Study type

Observational

Funder types

Other

Identifiers

NCT07406009
2025PI020

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 59 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

30 participants in 2 patient groups

Patient
Relative

Trial contacts and locations

0

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Central trial contact

François Feillet, MD, PhD; Eva Feigerlova, MD, PhD, MMEd

Data sourced from clinicaltrials.gov

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