The Effects of Kuvan on Functional Brain Connectivity in Individuals With Phenylketonuria (PKU)

Completed

Conditions studied: Phenylketonuria

In brief

The objective of the study is to determine whether Kuvan™ (sapropterin) improves the strength of the functional connectivity between brain regions in individuals with PKU.

Key facts

Study ID

NCT00964236

Run by

University of Missouri-Columbia

People needed

20

Starts

2009-08-01

Expected to finish

2011-08-01

Last updated by the study team

2018-01-04

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Willing and able to provide informed consent or assent.
• Willing and able to comply with study procedures.
• Greater than or equal to 6 years of age.
• For phenylketonuria, intention of physician to prescribe sapropterin.
• For phenylketonuria, phenylalanine level greater than or equal to 300μmol/L.
• For phenylketonuria, negative pregnancy test if of childbearing potential.
• For phenylketonuria, willing to use contraception if sexually active.

You may not qualify if…

• 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.
• Perceived to be unreliable or unavailable for study.
• Use of L-Dopa, methotrexate, or other drugs that inhibit folate metabolism.
• For phenylketonuria, known hypersensitivity to sapropterin or excipients.

Where it is running

• University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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