Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU)

Launched by EMORY UNIVERSITY · May 26, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new medication called Palynziq on patients with Phenylketonuria (PKU), a genetic condition that makes it hard for the body to process an important amino acid called phenylalanine (Phe). When Phe builds up in the body, it can cause serious problems, including difficulties with thinking and learning. Palynziq is designed to help lower Phe levels in the blood, which may allow patients to enjoy a less restricted diet while improving their overall health and well-being. The study aims to learn more about how this treatment affects diet quality, brain health, and patients' feelings about their mental and social health.

To participate in this trial, you need to be at least 16 years old and have a confirmed diagnosis of PKU. You should also be able to give consent for medical tests and be enrolled in a specific program that monitors the use of Palynziq. During the trial, participants can expect to undergo various assessments to track their health and dietary changes while using the medication. This research is important because it will help us understand how Palynziq can improve the lives of people living with PKU.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 16 years of age or older
• • diagnosed with PKU through newborn screening or via diagnosis later in life
• • capable of providing consent for medical tests and procedures
• • prescription for Palynziq and be enrolled in the Palynziq Risk Evaluation and Mitigation Strategy (REMS) program
• • Substudy: Participants must have completed visit 2 of the main study
• Exclusion Criteria:
• • unable to provide consent
• • a diagnosis of, or take medication for psychiatric, behavioral, or other inherited metabolic disorders