Study to Evaluate the Effects of Kuvan on Individuals With Phenylketonuria (PKU) With Maladaptive Behaviors

Completed

Conditions studied: Phenylketonuria

In brief

To validate the outcome measures and the tolerability of Kuvan treatment in the improvement of behavioral symptoms in 10 selected adults with Phenylketonuria (PKU) with or without mental retardation.

Key facts

Study ID

NCT00728676

Run by

Shoji Yano

People needed

10

Starts

2008-08-01

Expected to finish

2010-05-01

Last updated by the study team

2013-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Biochemical confirmation of PKU,
• Measurable maladaptive behavior at baseline,
• Signed informed consent,
• Not pregnant or lactating,
• Females on birth control if applicable,
• Willing to comply.

You may not qualify if…

• Subjects or care provider unreliable, use of investigational products within 30 days prior to enrollment,
• Pregnant or lactating,
• Concurrent disease or condition that would interfere with study participation or safety, ie multiple psychotropic meds, any condition the PI renders the subject at high risk, on drugs that inhibit folate synthesis,
• Concurrent use of levodopa.

Where it is running

• LAC+USC Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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