NCT00790400 - Efficacy and Safety of RAD001 in Patients Aged 18 and Over With Angiomyolipoma Associated With Either Tuberous Sclerosis Complex (TSC) or Sporadic Lymphangioleiomyomatosis (LAM) | Biotech Hunter

Enrollment

118

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

June 30, 2011

Study Completion Date

November 30, 2015

Conditions

Tuberous Sclerosis Complex (TSC)Lymphangioleiomyomatosis (LAM)

Interventions

DRUG

Everolimus (RAD001)

Everolimus is used in 5 mg strength tablets, blister-packed under aluminum foil in units of ten tablets and dosed on a daily basis. 10mg daily dosing throughout the trial.

DRUG

Everolimus Placebo

Matching placebo was provided as a matching tablet and was also blister-packed under aluminum foil in units of ten.

Trial Locations (25)

10098

Novartis Investigative Site, Berlin

10126

Novartis Investigative Site, Torino

35294

University of Alabama at Birmingham, Birmingham

38103

LeBonheur Childrens Medical Group SC-2, Memphis

53100

Novartis Investigative Site, Siena

69003

Novartis Investigative Site, Lyon

80336

Novartis Investigative Site, München

85013

Barrow Tuberous Sclerosis Center, Phoenix

127412

Novartis Investigative Site, Moscow

02114

Massachusetts General Hospital Massachussetts General Hospita, Boston

55102-2383

Minnesota Epilepsy Group, Saint Paul

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

M5G 2C4

Novartis Investigative Site, Torono

00137

Novartis Investigative Site, Roma

060-8648

Novartis Investigative Site, Sapporo

565-0871

Novartis Investigative Site, Suita

990-9585

Novartis Investigative Site, Yamagata

3584CX

Novartis Investigative Site, Utrecht

01138

Novartis Investigative Site, Warsaw

04-730

Novartis Investigative Site, Warsaw

08025

Novartis Investigative Site, Barcelona

BN2 5BE

Novartis Investigative Site, Brighton

BT63 5QQ

Novartis Investigative Site, Craigavon

CF14 4XN

Novartis Investigative Site, Cardiff

SW17 0QT

Novartis Investigative Site, London