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

NCT00789828 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2016-02-03

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticlas · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2011-03-31
Completion
2014-10-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Russia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00789828 on ClinicalTrials.gov