Behavioral Effects of Kuvan in Children With Mild Phenylketonuria
Stopped early
Conditions studied: Phenylketonuria
In brief
The purpose of this study is to determine whether improvements in behavior occur in children with phenylketonuria (PKU) who are taking Kuvan.
Key facts
- Study ID
- NCT00827762
- Run by
- Washington University School of Medicine
- People needed
- 2
- Starts
- 2009-01-01
- Expected to finish
- 2010-01-01
- Last updated by the study team
- 2013-12-05
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Willing and able to provide informed consent and/or assent.
- Willing and able to comply with study procedures.
- Between 6 and 18 years of age, inclusive.
- Intention of physician to prescribe Kuvan.
- Phenylalanine levels between 360μmol/L and 600μmol/L, inclusive, when untreated with dietary restrictions.
- Negative pregnancy test if of childbearing potential.
- Willing to use contraception if sexually active.
You may not qualify if…
- Treatment with Kuvan within the past 6 months.
- Pregnant, breastfeeding, or planning to become pregnant during study.
- Use of investigational product less than 30 days prior to or during study.
- Concurrent condition that could interfere with participation or safety.
- Any condition creating high risk of poor compliance with study.
- History of major medical disorder unrelated to phenylketonuria.
- Perceived to be unreliable or unavailable for study.
- Use of L-Dopa, methotrexate, or other drugs that inhibit folate metabolism.
- Known hypersensitivity to sapropterin or excipients.
Where it is running
- Northwestern University/Children's Memorial Hospital — Chicago, Illinois, United States
- University of Missouri — Columbia, Missouri, United States
- Washington University — St Louis, Missouri, United States
- Oregon Health & Science University — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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