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NCT04706013 · ClinicalTrials.gov registry record · Phase 3
Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency
A Phase 3 study of Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency, sponsored by Medicure.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 7
- Study locations
NCT04706013 is a Phase 3 study of Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency that is actively recruiting participants, run by Medicure. The registered enrollment target is 15 participants. The trial reports 7 study locations across 7 states.
The verdict
NCT04706013, a Phase 3 study of Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency, is actively recruiting participants, sponsored by Medicure.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
- 7
- Study locations
Study Summary
The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available. Patients will receive pharmaceutical grade P5P according to their normal oral P5P dosing regimen, as previously established by their physicians.
Conditions Studied
Interventions
- DRUG Pyridoxal Phosphate
Study Locations (7)
Alabama
- Children's Hospital of Alabama - Birmingham
California
- Lucile Packard Children's Hospital - Palo Alto
Colorado
- Children's Hospital Colorado - Aurora
Massachusetts
- Boston Children's Hospital - Boston
North Carolina
- Duke Children's Hospital - Durham
Ohio
- Akron's Children's Hospital - Akron
Queensland
- Queensland Children's Hospital - South Brisbane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-02-16 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04706013
The ClinicalTrials.gov registry entry for NCT04706013 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medicure, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Pyridoxal Phosphate is the first listed.
NCT04706013 reports 7 study locations spanning 7 distinct geographic areas - top geographies include Alabama, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04706013 about?
NCT04706013 is a clinical study titled "Oral Pyridoxal 5'-Phosphate for the Treatment of Patients With PNPO Deficiency". The proposed clinical study is intended to evaluate oral P5P for the treatment of patients confirmed to have Pyridox(am)ine 5'-Phosphate Oxidase (PNPO) deficiency via genetic analysis. There is an unmet clinical need for pharmaceutical grade P5P, as to date none has been made commercially available....
What is the current status of trial NCT04706013?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2024-02-16. Estimated completion is 2026-11.
What conditions does trial NCT04706013 study?
This clinical trial studies the following conditions: Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency.
What interventions are being tested in trial NCT04706013?
The interventions under investigation include: Pyridoxal Phosphate (DRUG).
Who is sponsoring clinical trial NCT04706013?
This trial is sponsored by Medicure, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04706013 being conducted?
This trial has 7 study locations across Alabama, California, Colorado, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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