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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)

Trial Profile

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 of Trial: Phase III

Latest Information Update: 23 Jul 2019

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At a glance

  • Drugs Everolimus (Primary)
  • Indications Astrocytoma; Tuberous sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms EXIST-1
  • Sponsors Novartis
  • Most Recent Events

    • 19 Jul 2018 Results assessing the effect of everolimus on renal function in patients with tuberous sclerosis complex from EXIST-1 and EXIST-2 studies, published in the Nephrology Dialysis Transplantation.
    • 21 Apr 2016 Results (n=119) of pooled analysis of 3 studies (NCT00411619, NCT00789828 and NCT00790400) analysing endocrine and menstrual cycle-related events in females presented at the 68th Annual Meeting of the American Academy of Neurology
    • 08 Mar 2016 Long-term results from this trial and from EXIST-2 trial presented at the 74th Annual Meeting of the American Academy of Dermatology
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