A Phase 3 interventional study of Pyridoxal 5'-Phosphate in Pyridox(am)Ine 5'-Phosphate Oxidase Deficiency, sponsored by Medicure. Recruiting at 5 sites in 2 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Medicure · Phase 3, Interventional, and Treatment
Continued access to MC-1 is required by subjects who have participated in the MEND-PNPO study, as no other pharmaceutical grade P5P is currently commercially available. The protocol duration is planned for until the finished product is commercially available in the respective countries where subjects are participating in the study.
Medicure is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oral MC-1
Drug: Pyridoxal 5'-Phosphate
Oral tablets
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
All adverse and serious adverse events will be collected, along with monitoring for symptoms and signs of B6 intoxication and changes to liver enzymes (evaluation for potential hepatotoxicity).
Time frame: Through study completion, up to 4 years
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Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Pyridoxal Phosphate
Medicure