Effect of Large Neutral Amino Acids in Adults With Classical Phenylketonuria
Condition(s) studied
Investigational drug(s) / intervention(s)
PreKUnil® LNAA Medical Food for PKU: PreKUnil® LNAA Medical Food for PKU is a commercially available active LNAA treatment product for PKU.
Study summary
The overall aim of this study is to evaluate LNAA treatment as a potential alternative to conventional dietary treatment for PKU. This study investigates the effects of LNAA treatment compared to the classic dietary treatment on cerebral dopamine synthesis in patients with classic PKU. We will assess LNAAs effectiveness on neurotransmitter synthesis, cognitive function, mental health, and safety, compared to the standard diet.
Eligibility
Primary outcome measure(s)
- 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) — Crossover study: at 8, 10 and 18 weeks from baseline, Extension study: at 12 months from baseline
Change in specific binding ratio of dopamine transporter (DaT) with \[18F\]FE-PE2I
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Center for Inherited Metabolic Diseases | Copenhagen | Denmark | Recruiting |
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark | Not Yet Recruiting |
More Copenhagen University Hospital, Rigshospitalet trials in Denmark
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06337864 on ClinicalTrials.gov ↗ ← All trials in Denmark