drugset / Trial / NCT00838435

Effect of Kuvan on Neurocognitive Function, Blood Phenylalanine Level, Safety, and Pharmacokinetics in Children With PKU

NCT00838435

Phase 3 Completed 95 enrolled BioMarin Pharmaceutical
NaSingle-groupOpen-labelTreatment

Summary

This multicenter, open label study is designed to evaluate the safety of Kuvan® and its effect on neurocognitive function, blood Phe concentration, and growth in children with PKU who are 0-6 years old.

Timeline

Start
2009-02
Primary completion
2018-09-14
Completion
2018-09-14

Drugs

EvaluationDrugModalityDoseRoute
Subject sapropterin Unknown 20 mg/kg Oral

Indications