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A Phase 3 Substudy to Evaluate Executive Function in Adults With PKU Who Are Participating in the Phase 3 Study, 165-302

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Trial Status Completed

Trial Identifier

NCT02468570

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

A Phase 3 substudy to evaluate executive function in adults with phenylketonuria who are participating in the phase 3 Study, 165-302. Approximately 100 subjects, aged ≥ 18 to ≤ 70 years old, with PKU will be enrolled.

Eligibility Criteria

Birth Sex

All

Age

18 Years to 70 Years

Healthy Volunteers

No

Drug/Treatment:

Administration of CANTAB and Subject Global Assessment

Study Type:

Observational

Number of Participants:

9

Study Started:

2015-08-05

Study Updated:

2020-06-04

Trial Locations

  • University of Kentucky Medical Center

    Lexington, Kentucky, United States

  • University of Nebraska Medical Center

    Omaha, Nebraska, United States

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States

  • Oregon Health and Science University

    Portland, Oregon, United States

Inclusion Criteria

  • Are currently participating in Part 1 of Study 165-302 and meet the criteria for participation in Part 2 of 165-302
  • Are willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any research-related procedures.
  • Have the ability to complete the CANTAB and subject global assessment.
  • Are willing and able to comply with all study procedures.

Exclusion Criteria

  • Any condition that, in the view of the investigator, places the subject at high risk of poor compliance or terminating early from the stud

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