Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU

PHASE3CompletedINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

July 29, 2013

Primary Completion Date

January 13, 2016

Study Completion Date

February 5, 2019

Conditions
Phenylketonuria (PKU)
Interventions
DRUG

BMN165 20mg/day

BMN165 20mg/day self-administered daily

DRUG

BMN165 40mg/day

BMN165 40mg/day self-administered daily

DRUG

Placebo

Non-drug placebo, self-administered daily

Trial Locations (29)

10029

Icahn School of Medicine at Mount Sinai Medical Center, New York

12208

Albany Medical Center, Albany

15224

Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh

19134

St. Christopher's Hospital for Children, Philadelphia

30322

Emory Universty, Department of Human Genetics, Division of Medical Genetics, Atlanta

32610

University of Florida Clinical Research Center, Gainesville

33606

University of South Florida, Tampa

37232

Vanderbilt Children's Hospital, Nashville

40202

University of Louisville, Kosair Charities Pediatric Clinical Research Unit, Louisville

40536

University of Kentucky Medical Center, Lexington

44106

University Hospitals Case Medical Center, Cleveland

46202

Indiana CTSI Clinical Research Center, Indianapolis

48202

Wayne State University Clinical Research Center at the Mott Center, Detroit

53226

Medical College of Wisconsin, Milwaukee

60611

Ann and Robert H Lurie Children's Hospital of Chicago, Chicago

63110

Washington University Center for Applied Research Sciences, St Louis

65212

University of Missouri Health Center, Columbia

68198

University of Nebraska Medical Center, Omaha

73104

University of Oklahoma Health Sciences Center, Oklahoma City

77030

University of Texas Houston Medical School, Houston

80045

Children's Hospital Colorado, Aurora

84108

University of Utah Hospital, Salt Lake City

92093

University of California, San Diego Clinical and Translational Research Institute, La Jolla

94609

UCSF Benioff Children's Hospital Oakland, Oakland

97239

Oregon Health and Science University, Portland

98195

University of Washinton, Seattle

02115

Boston Children's Hospital, Boston

08103

Cooper Health Systems, Camden

07960

Atlantic Health System - Morristown Medical Center, Morristown

Sponsors
All Listed Sponsors
lead

BioMarin Pharmaceutical

INDUSTRY