NL-OMON48912
Completed
Not Applicable
An open-label, explorative, post launch, multicenter, multi-country intervention study of PKU Synergy (an amino-acid mixture) to evaluate change in nutrient intake in PKU subjects with an increased Phe-tolerance/intake. - ESSENTIA
utricia Research0 sites2 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- utricia Research
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. PKU subjects identified by newborn screening and started low\-Phe diet before
- •3 months of age.
- •2\. PKU subjects with an increased Phe\-tolerance/intake due to: mild PKU
- •phenotype or BH4 treatment.
- •3\. If treated with BH4, PKU subjects should be on a stable BH4 treatment for at
- •least 26 consecutive weeks up to start test product intake.
- •4\. Age\*12 years.
- •5\. If subjects (irrespective whether BH4 users or mild PKU) use amino\-acid
- •mixture(s; AAM), then a maximum of 25 Protein Equivalents (PE) derived from the
- •AAM per day applies and usage on a daily basis for at least 26 consecutive
Exclusion Criteria
- •1\. For women: Currently pregnant or lactating.
- •2\. Current or prior use of the test product within six weeks prior to entry
- •into the study.
- •3\. Concurrent conditions (including renal failure and severe hepatic failure)
- •and medication that could interfere with participation, outcome parameters or
- •safety (as determined by Investigator).
- •4\. Psychotropic medication (i.e. medication affecting the nervous system) and
- •inotropic medication.
- •5\. Any condition creating high risk of poor compliance with study.
- •6\. Participation in any other studies involving investigational or marketed
Outcomes
Primary Outcomes
Not specified
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