Phenylketonuria Trial, Recruiting NCT06969209 Sponsor: Insel Gruppe AG, University Hospital Bern Condition: Phenylketonuria
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Phenylketonuria Trial, Recruiting

NCT06969209
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

For people with PKU (Phenylketonuria):

Who might be able to join this trial:

  • You have taken part in the PICO Study, or meet the criteria listed below
  • You were diagnosed with PKU through a newborn screening test
  • You started a low-phenylalanine (Phe) diet within the first 30 days of life
  • You are 18 years old or older
  • You are willing and able to give written consent to take part

Who may not be able to join:

  • You have not been following a low-phenylalanine diet in the 6 months before the study
  • Your phenylalanine blood levels were too high (above a certain level) in the 6 months before the study (confirm with trial site)
  • You have another health condition that could significantly affect the study results (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have metal particles in your head or brain, a pacemaker, deep brain stimulators, a cochlear implant, braces, or permanent retainers, as these interfere with MRI scans

For healthy volunteers (people without PKU):

Who might be able to join this trial:

  • You are 18 years old or older
  • You are willing and able to give written consent to take part

Who may not be able to join:

  • You have a health condition that could significantly affect the study results (confirm with trial site)
  • You are currently pregnant or breastfeeding
  • You have difficulty following study instructions, for example due to not speaking German or French fluently, psychological disorders, or dementia
  • You have metal particles in your head or brain, a pacemaker, deep brain stimulators, a cochlear implant, braces, or permanent retainers, as these interfere with MRI scans

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Regula Everts, Prof. Dr. phil., Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital and University of Bern, Switzerland

Phone: +41 31 63 2 84 97

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Insel Gruppe AG, University Hospital Bern
Registry
ClinicalTrials.gov
Start date
13 January 2025
Est. completion
30 May 2030

Where this trial is recruiting

🇨🇭 Switzerland

Primary endpoints

Brain Age Gap; Sustained Attention; Cognitive flexibility; Plasma concentration of Phe; Diffusion tensor imaging (DTI); Arterial Spin Labeling (ASL)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov