Phenylketonuria Trial, Recruiting
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
Who might be able to join this trial:
- You are 18 years of age or older
- You have been diagnosed with Classical PKU (a condition affecting how the body processes a substance called phenylalanine), confirmed either through genetic testing showing two faulty copies of a specific gene, or through historical blood test results showing very high phenylalanine levels
- Your PKU treatment was started within the first month of your life
- You scored above 84 on an IQ test carried out as part of the study's initial assessments
- You followed a special low-phenylalanine diet as your main treatment until at least 15 years of age
- You are willing and able to follow all the study requirements and procedures
- You have signed a form giving your informed consent to take part
Who may not be able to join:
- You are unable or unwilling to follow the study's requirements
- You are female and are currently pregnant, breastfeeding, or planning to become pregnant during the study period
- You are taking certain medications that could affect a specific brain scan (called a PET scan) used in this study (confirm with trial site)
- You have a serious mental health or neurological condition that could affect your ability to take part, as decided by the study doctor
- You are currently being treated with sapropterin (also known as BH4) or a medication called Pegvaliase/PALYNZIQ
- You have not provided at least one home blood sample to measure your phenylalanine levels in the year before the study begins
- You have any condition or implant that would prevent you from safely having an MRI scan (confirm with trial site)
- Your body weight is over 110 kg (approximately 243 lbs or 17 stone)
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.
Contact this trial
Principal Investigator: Allan Lund, Professor, MD, DMSc, Rigshospitalet, Denmark
Phone: +4535451303
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
Where this trial is recruiting
Primary endpoints
Dynamic positron emission tomography (PET) imaging with the fluorine-18-labeled tracer [18F]-(E)-N-(3-iodoprop-2-enyl)-2β-carbofluoroethoxy-3β-(4'-methyl phenyl)nortropane ([18F]FE-PE2I)
Can't join this trial?
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.