Effects of Palynziq on diet and health in patients with PKU

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the nutritional impacts of Palynziq, a newly approved medication for patients with Phenylketonuria (PKU). It aims to assess changes in diet quality, neurological health, nutritional status, and patient perceptions of mental and social health among individuals receiving Palynziq therapy. By capturing these effects, the study seeks to provide insights into how this treatment can improve metabolic control and overall well-being for PKU patients. Participants must be 16 years or older and enrolled in the Palynziq Risk Evaluation and Mitigation Strategy program.

Why it matters

Who can join: the full rules

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

Where it's running

• Emory University Hospital Georgia Clinical Research Center
  Atlanta, Georgia, United States Recruiting
• The Emory Clinic
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Rani Singh, PhD, RDN, LD — Emory University
• Study coordinator: Rani Singh, PhD, RDN, LD
• Email: rsingh@emory.edu
• Phone: 778-404-8519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Investigating the impact of dietary guidelines on well-being in patients with Phenylketonuria

  This study looks at how following dietary guidelines affects the health and well-being of people with Phenylketonuria (PKU) who are 10 years and older.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.