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NCT05356377 · ClinicalTrials.gov registry record

Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU

A clinical trial, sponsored by University of Missouri-Columbia.

Completed
Registry status
6
Enrollment target

NCT05356377 is a clinical trial that has completed, run by University of Missouri-Columbia. The registered enrollment target is 6 participants.

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The verdict

NCT05356377 has completed, sponsored by University of Missouri-Columbia.

COMPLETED
Registry status
6 participants
Enrollment target

Study Summary

The goal of the proposed study is to elucidate neurologic and neuropsychological improvements associated with Palynziq-related reduction in plasma Phe levels in individuals with PKU. To this end, investigators will utilize state-of-the-art neuropsychological and multi-modal neuroimaging methods to examine the effects of large Phe level reduction (levels \<360 μmol/L for at least 3 consecutive months) on GM and WM brain structures, brain concentrations of Phe, functionality of brain networks, and associated cognitive functioning in a sample of individuals with PKU who are being treated with Palyzniq.

Interventions

  • DRUG Pegvaliase-Pqpz

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2022-05-25
Est. Completion 2025-07-01

Sponsor

University of Missouri-Columbia

291 total trials

What the Registry Record Tells You About NCT05356377

The ClinicalTrials.gov registry entry for NCT05356377 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Pegvaliase-Pqpz is the first listed.

NCT05356377 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05356377 about?

NCT05356377 is a clinical study titled "Preliminary Study of Brain Effects of Palynziq-Related Changes in Phenylalanine in Individuals With PKU". The goal of the proposed study is to elucidate neurologic and neuropsychological improvements associated with Palynziq-related reduction in plasma Phe levels in individuals with PKU. To this end, investigators will utilize state-of-the-art neuropsychological and multi-modal neuroimaging methods to e...

What is the current status of trial NCT05356377?

This trial is currently completed. The enrollment target is 6 participants. The study started on 2022-05-25. Estimated completion is 2025-07-01.

What interventions are being tested in trial NCT05356377?

The interventions under investigation include: Pegvaliase-Pqpz (DRUG).

Who is sponsoring clinical trial NCT05356377?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.