117
Participants
Start Date
August 31, 2009
Primary Completion Date
March 31, 2011
Study Completion Date
October 31, 2014
Everolimus
Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets.
Placebo
Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.
Novartis Investigative Site, Brussels
Novartis Investigative Site, Randwick
Novartis Investigative Site, Berlin
Novartis Investigative Site, Genova
Children's Regional Outpatients Center SC, Fairfax
Children's Healthcare of Atlanta, Atlanta
University of Alabama at Birmingham, Birmingham
Novartis Investigative Site, Heidelberg
Texas Scottish Rite Hospital for Children, Dallas
Barrow Tuberous Sclerosis Center, Phoenix
University of California at Los Angeles, Los Angeles
Novartis Investigative Site, Moscow
Children's Hospital Oakland Hematology/Oncology Dept, Oakland
University of CHicago Comer Children's Hospital, Chicago
Massachusetts General Hospital Mass General, Boston
Children's Hospital Boston SC-1, Boston
Minnesota Epilepsy Group - PA, Saint Paul
Cincinnati Children's Hospital Medical Center Cincinnati Children's Hosp, Cincinnati
Novartis Investigative Site, Toronto
Novartis Investigative Site, Québec
Novartis Investigative Site, Roma
Novartis Investigative Site, Utrecht
Novartis Investigative Site, Warsaw
Novartis Investigative Site, Bristol
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY