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

Completed

Conditions studied: Phenylketonuria

In brief

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.

Key facts

Study ID

NCT02468570

Run by

BioMarin Pharmaceutical

People needed

9

Starts

2015-08-05

Expected to finish

2017-02-01

Last updated by the study team

2020-06-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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