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

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Trial Status Completed

Trial Identifier

NCT00728676

Condition

Phenylketonuria

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial Summary

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.

Eligibility Criteria

Birth Sex

All

Age

From 18 Years

Healthy Volunteers

No

Study Type:

Observational

Number of Participants:

10

Study Started:

2008-08

Study Updated:

2013-01-18

Trial Locations

  • LAC+USC Medical Center

    Los Angeles, California, United States

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

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