Status:
COMPLETED
Nutritional and Neurotransmitter Changes in PKU Subjects on BH4
Lead Sponsor:
Emory University
Collaborating Sponsors:
BioMarin Pharmaceutical
Atlanta Clinical and Translational Science Institute
Conditions:
Phenylketonuria
Eligibility:
All Genders
4+ years
Brief Summary
HYPOTHESIS: The investigators hypothesize that KuvanTM therapy could influence nutritional and body composition parameters and neurotransmitter concentrations in pediatric and adult PKU subjects. SUM...
Detailed Description
BACKGROUND : Tetrahydrobiopterin (BH4) is a treatment option newly available to phenylketonuria (PKU) patients within the United States as the pharmaceutical KuvanTM. This small molecule functions as ...
Eligibility Criteria
Inclusion
- Diagnosed with PKU
- ability to provide informed consent (or have legal guardian who can provide informed consent)
- at least 4 years of age
- planning on trying BH4 treatment
Exclusion
- Pregnant
- unable to provide informed consent
- less than 4 years of age
- currently taking BH4
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00688844
Start Date
October 1 2008
End Date
October 1 2010
Last Update
June 8 2015
Active Locations (2)
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1
Emory Hospital, CIN/ACTSI
Atlanta, Georgia, United States, 30322
2
Emory University Genetics Clinic
Decatur, Georgia, United States, 30033