A Randomized Placebo-Controlled Study of Lovastatin in Children With Neurofibromatosis Type 1

PHASE2CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

May 31, 2014

Study Completion Date

December 31, 2016

Conditions
Neurofibromatosis Type 1
Interventions
DRUG

Lovastatin ™

Lovastatin starting at 20mg for 2 weeks, increasing to 40mg for 14 weeks. Total duration of trial is 16 weeks.

DEVICE

placebo

Starting at 20mg for 2 weeks, then increasing to 40mg for 14 additional weeks for a total duration of treatment of 16 weeks.

Trial Locations (12)

2145

The Children's Hospital at Westmead, Westmead

19096

Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Medical Center, Washington D.C.

20892

NIH, Bethesda

35294

The University of Alabama at Birmingham, Birmingham

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

60637

University of Chicago, Chicago

63110

Washington University - St. Louis, St Louis

75235

Childrens Medical Center - Univ. of Texas SW Medical Center, Dallas

84132

University of Utah, Salt Lake City

90027

Children's Hospital Los Angeles, Los Angeles

02115

Children' Hospital Boston, Boston

All Listed Sponsors
collaborator

Boston Children's Hospital

OTHER

collaborator

Children's Hospital of Philadelphia

OTHER

collaborator

Children's National Research Institute

OTHER

collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

collaborator

National Cancer Institute (NCI)

NIH

collaborator

University of Chicago

OTHER

collaborator

University of Utah

OTHER

collaborator

Washington University School of Medicine

OTHER

collaborator

Sydney Children's Hospitals Network

OTHER

collaborator

University of Texas Southwestern Medical Center

OTHER

lead

University of Alabama at Birmingham

OTHER