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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: Completed study, sponsored by University of Missouri-Columbia.
NCT05356377 is a clinical trial that has completed, run by University of Missouri-Columbia. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Brain phenylalanine (Phe) levels, white matter integrity, gray matter integrity, functional connectivity as measured using magnetic resonance imaging (MRI)
Interventions
- DRUG Pegvaliase-Pqpz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2022-05-25 |
| Est. Completion | 2025-07-01 |
What the finished NCT05356377 record still lists
NCT05356377 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Pegvaliase-Pqpz is the first listed.
NCT05356377 does not publish any study locations in the registry export this page uses.
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.
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