Phenylketonuria Trial, Recruiting NCT04404530 Sponsor: Emory University Condition: Phenylketonuria
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Phenylketonuria Trial, Recruiting

NCT04404530
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 16 years of age or older
  • You have been diagnosed with PKU (phenylketonuria), either through newborn screening or through a diagnosis later in life
  • You are able to give your own consent to take part in medical tests and procedures
  • You have a prescription for Palynziq and are already enrolled in the Palynziq REMS (a special safety program required for this medication)
  • (For the sub-study only) You have already completed the second visit of the main study

Who may not be able to join:

  • You are not able to give your own consent to take part in the trial
  • You have been diagnosed with, or take medication for, a psychiatric condition, a behavioral disorder, or another inherited metabolic disorder

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Rani Singh, PhD, RDN, LD, Emory University

Phone: 778-404-8519

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
8 October 2019
Est. completion
1 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Intra-subject Change in Intact Protein Intake; Intra-subject Change in Medical Food Protein Intake; Sub study: Intra-subject change in intact protein and medical food protein intake.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov