Safety and Therapeutic Effects of Sapropterin Dihydrochloride on Neuropsychiatric Symptoms in Phenylketonuria (PKU) Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

206

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

March 31, 2013

Study Completion Date

March 31, 2013

Conditions
Phenylketonuria
Interventions
DRUG

Sapropterin dihydrochloride

A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).

DRUG

Placebo

Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.

Trial Locations (36)

Unknown

La Jolla

Los Angeles

Palo Alto

San Francisco

Aurora

Washington D.C.

Gainesville

Tampa

Atlanta

Chicago

Indianapolis

Boston

Minneapolis

Albany

Buffalo

Rochester

Chapel Hill

Cleveland

Portland

Hershey

Philadelphia

Pittsburgh

Nashville

Dallas

Madison

Milwaukee

Calgary

Edmonton

Vancouver

Winnipeg

Halifax

Hamilton

Kingston

London

Toronto

Montreal

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY