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

PHASE3CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

September 14, 2018

Study Completion Date

September 14, 2018

Conditions
Phenylketonuria
Interventions
DRUG

sapropterin dihydrochloride

A dose of 20 mg/kg will be administered dissolved in water or apple juice, based on subject's age and ability, and taken orally once daily with food.

Trial Locations (19)

Unknown

La Jolla

Orange

Tampa

Chicago

Boston

Kansas City

Cleveland

Columbus

Hershey

Nashville

Salt Lake City

Milwaukee

Edmonton

Vancouver

Winnipeg

Hamilton

Toronto

Montreal

Sainte-Foy

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY