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PKU EASY Microtabs Plus - Acceptability and Tolerance

NCT06694662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-11-26

No results posted yet for this study

Summary

PEMP-AT is a prospective, single-arm, open-label, 1-week acceptability study to evaluate PKU EASY Microtabs Plus for the dietary management of participants with phenylketonuria (PKU). Up to 10 participants aged 3 years and above will be recruited in a single-centre in the UK.

Conditions

  • Phenylketonuria (PKU)

Interventions

DIETARY_SUPPLEMENT

PKU EASY Microtabs Plus

PKU EASY Microtabs Plus is a food for special medical purposes (FSMP). This product is for use in the dietary management of Phenylketonuria (PKU) in patients from 3 years of age upwards. PKU EASY Microtabs Plus is a microtablet form, slow-release, phenylalanine-free protein substitute containing a blend of essential and non-essential amino acids, vitamins, minerals and trace elements.

Sponsors & Collaborators

  • Birmingham Women's and Children's NHS Foundation Trust

    collaborator OTHER

  • Galen Limited

    lead INDUSTRY

Principal Investigators

  • Anita MacDonald, Ph.D. · Birmingham Women's and Children's NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2025-08-13
Completion
2025-08-13

Countries

  • United Kingdom

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 NCT06694662 on ClinicalTrials.gov