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

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Trial Status Completed

Trial Identifier

NCT00964236

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

Eligibility Criteria

Birth Sex

All

Age

From 6 Years

Healthy Volunteers

Yes

Drug/Treatment:

Sapropterin

Study Type:

Observational

Number of Participants:

20

Study Started:

2009-08

Study Updated:

2018-01-04

Trial Locations

  • University of Missouri

    Columbia, Missouri, United States

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

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