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Open-label, Randomized, 2-way Crossover, Monocentric, Controlled Study to Evaluate the Effect on Daily PHE Fluctuation of PKU GOLIKE Versus SoC in Patients With PKU.

NCT05827536 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2026-03-11

Study results available
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Summary

This is an open-label, randomized, 2-way crossover, monocentric controlled study in patients (≥ 16 years old) with phenylketonuria (PKU).

The comparison will be between the test product (PKU GOLIKE, a prolonged-release amino-acids (AAs) mixture) and standard of care.

Conditions

  • Phenylketonurias

Interventions

DIETARY_SUPPLEMENT

PKU GOLIKE

PKU GOLIKE is a food for special medicinal purposes (FSMP) for the dietary management of PKU.

DIETARY_SUPPLEMENT

Standard of Care

Protein substitute

Sponsors & Collaborators

  • APR Applied Pharma Research s.a.

    lead OTHER

Principal Investigators

  • Valentina Rovelli, MD · ASST Santi Paolo e Carlo, Presidio Ospedale San Paolo, Via Antonio di Rudinì 8 - 20142, Milano (Italy)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2024-11-27
Completion
2024-11-27

Countries

  • Italy

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 NCT05827536 on ClinicalTrials.gov