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Behavioral Effects of Kuvan in Children With Mild Phenylketonuria

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Trial Status Terminated

Trial Identifier

NCT00827762

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

The purpose of this study is to determine whether improvements in behavior occur in children with phenylketonuria (PKU) who are taking Kuvan.

Eligibility Criteria

Birth Sex

All

Age

6 Years to 18 Years

Healthy Volunteers

No

Drug/Treatment:

Kuvan

Study Type:

Observational

Number of Participants:

2

Study Started:

2009-01

Study Updated:

2013-12-05

Trial Locations

  • 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

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

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