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Effect of Large Neutral Amino Acids in Adults With Classical Phenylketonuria

NCT06337864 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-06

No results posted yet for this 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.

Conditions

  • Brain Diseases
  • Brain Diseases, Metabolic
  • Brain Diseases, Metabolic, Inborn
  • Genetic Diseases, Inborn
  • Metabolism, Inborn Errors
  • Amino Acid Metabolism, Inborn Errors
  • Metabolic Disease
  • Phenylketonurias

Interventions

OTHER

PreKUnil® LNAA Medical Food for PKU

PreKUnil® LNAA Medical Food for PKU is a commercially available active LNAA treatment product for PKU.

Sponsors & Collaborators

  • Prekulab Ltd ApS

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Allan Lund, Professor, MD, DMSc · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06337864 on ClinicalTrials.gov