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NCT07406009: CoMet-PCU

The Psychosocial Functioning of Adults With Phenylketonuria.

Not yet recruiting Last updated 12 February 2026
What this trial tests

trial in Phenylketonuria (PKU) in 30 participants. Not yet recruiting.

Timeline
15 January 2026
Primary endpoint
15 March 2027
15 June 2027

Quick facts

Lead sponsorCentral Hospital, Nancy, France
StatusNot yet recruiting
Study typeOBSERVATIONAL
Enrollment30
Start date15 January 2026
Primary completion15 March 2027
Estimated completion15 June 2027

Conditions studied

Sponsor

Central Hospital, Nancy, France

Who can join

Adults 18 to 59, any sex, with Phenylketonuria (PKU). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Phenylketonuria (PKU)

Currently open trials in the same condition.

Other Central Hospital, Nancy, France trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07406009.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing