NCT00789828

Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)

A Randomized, Double-blind, Placebo-controlled Study of Everolimus in the Treatment of Patients With Subependymal Giant Cell Astrocytomas (SEGA) Associated With Tuberous Sclerosis Complex (TSC)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.

Conditions

• Tuberous Sclerosis
• Subependymal Giant Cell Astrocytoma

Interventions

Type	Name	Description
DRUG	Everolimus	Everolimus was formulated as tablets of 1.0-mg strength and was blisterpacked under aluminum foil in units of 10 tablets.
DRUG	Placebo	Placebo was provided as a matching tablet and was blisterpacked under aluminum foil in units of 10.

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-03-01
• Completion: 2014-10-01
• First posted: 2008-11-13
• Last updated: 2016-02-03
• Results posted: 2012-05-01

Locations

24 sites across 10 countries: United States, Australia, Belgium, Canada, Germany, Italy, Netherlands, Poland, Russia, United Kingdom