Phase
Condition
N/ATreatment
Pyridoxal Phosphate
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with confirmed PNPO deficiency via genetic analysis, whose seizures aretypically controlled on P5P (oral) therapy. a. Typically controlled is defined as receiving multiple doses of P5P daily tocontrol seizures. Receiving P5P for a minimum of 30 days.
Male and/or female patients.
Patients with previous failed treatment on pyridoxine are eligible for the study (patient should be off pyridoxine for at least 24 hours).
Written informed consent (by parent or guardian if under the age of 18).
Exclusion
Exclusion Criteria:
The patient has any condition or abnormality which may, in the opinion of theInvestigator, compromise the safety of the patient, or influence their ability tocomply with study procedures.
Known or suspected allergy to the trial drug or the relevant drugs given in thetrial.
Involvement in a clinical research study within 4 weeks prior to screening and/orprior enrollment in the study. Participation in observational registry studies ispermitted.
Study Design
Connect with a study center
Queensland Children's Hospital
South Brisbane, Queensland
AustraliaSite Not Available
Children's Hospital of Alabama
Birmingham, Alabama 35233
United StatesActive - Recruiting
Lucile Packard Children's Hospital
Palo Alto, California 94304
United StatesActive - Recruiting
Boston Children's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Duke Children's Hospital
Durham, North Carolina 27705
United StatesSite Not Available
Akron's Children's Hospital
Akron, Ohio 44308
United StatesActive - Recruiting
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