Completed OBSERVATIONAL NCT01274026

Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression Kuvan Nonresponders (IST)

Evaluation of Behavior, Executive Function, Neurotransmitter Function and Genomic Expression in PKU Nonresponders to Kuvan® (Sapropterin Dihydrochloride)

Sponsor: BioMarin Pharmaceutical

Conditions Behavior and Behavior Mechanisms PAH Gene Expression Phenylketonuria

Interventions sapropterin dihydrochloride

Updated 8 times since 2017 Last updated: Aug 10, 2023 Started: Jan 31, 2011 Primary completion: Dec 31, 2013 Completion: Dec 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Behavior and Behavior Mechanisms and PAH Gene Expression, this trial is completed. The trial is conducted by BioMarin Pharmaceutical and has accumulated 8 data snapshots since 2011. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed
Jul 2024 — Sep 2024 [monthly]

Completed
Sep 2023 — Jul 2024 [monthly]

Completed
Jan 2021 — Sep 2023 [monthly]

Completed
Oct 2018 — Jan 2021 [monthly]

Completed

Status: Unknown Status → Completed · Phase: NA → None

▶ Show 3 earlier versions

Jun 2018 — Oct 2018 [monthly]

Unknown Status NA
Feb 2017 — Jun 2018 [monthly]

Unknown Status NA
Jan 2017 — Feb 2017 [monthly]

Unknown Status NA

First recorded

Jan 2011

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

BioMarin Pharmaceutical
Tulane University School of Medicine

Data source: Tulane University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• New Orleans, United States